Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)

• ClinicalTrials.gov Identifier: NCT04624204
• Recruitment Status: Recruiting
• First Posted: November 10, 2020
• Last Update Posted: June 8, 2023
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Study Description

Brief Summary:

The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).

Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.

Hypothesis (H2): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.

Hypothesis (H3): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to OS.

Hypothesis (H4): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to OS.

Condition or disease	Intervention/treatment	Phase
Small Cell Lung Cancer	Biological: Pembrolizumab 200 mg; Biological: Pembrolizumab 400 mg; Drug: Pembrolizumab placebo (saline); Drug: Olaparib 300 mg BID; Drug: Olaparib matching placebo; Drug: Etoposide 100 mg/m^2; Drug: Platinum, investigator's choice; Radiation: Standard Thoracic Radiotherapy; Radiation: Prophylactic Cranial Irradiation (PCI)	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 672 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants With Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC)
• Actual Study Start Date: December 8, 2020
• Estimated Primary Completion Date: October 28, 2027
• Estimated Study Completion Date: October 28, 2027

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group A - Pembrolizumab 200 mg; Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab 200 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab 400 mg every 6 weeks (Q6W) plus olaparib matching placebo twice daily (BID) for 12 months or until specific discontinuation criteria are met.	Biological: Pembrolizumab 200 mg; Pembrolizumab 200 mg Q3W; Other Names: MK-3475; KEYTRUDA®; Biological: Pembrolizumab 400 mg; Pembrolizumab 400 mg Q6W; Other Names: MK-3475; KEYTRUDA®; Drug: Olaparib matching placebo; Olaparib matching placebo BID; Drug: Etoposide 100 mg/m^2; Etoposide 100 mg/m^2 intravenous (IV) Q3W, Day 1-3; Drug: Platinum, investigator's choice; Carboplatin titrated to an area under the plasma drug concentration time curve (AUC) of 5 mg/mL/min IV Q3W OR Cisplatin 75 mg/m^2 IV Q3W on Day 1 of each cycle; Radiation: Standard Thoracic Radiotherapy; Standard Thoracic Radiotherapy; Radiation: Prophylactic Cranial Irradiation (PCI); PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
Experimental: Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID; Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab 200 mg Q3W concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab 400 mg Q6W plus olaparib 300 mg BID for 12 months or until specific discontinuation criteria are met.	Biological: Pembrolizumab 200 mg; Pembrolizumab 200 mg Q3W; Other Names: MK-3475; KEYTRUDA®; Biological: Pembrolizumab 400 mg; Pembrolizumab 400 mg Q6W; Other Names: MK-3475; KEYTRUDA®; Drug: Olaparib 300 mg BID; Olaparib 300 mg twice daily (BID); Other Names: MK-7339; LYNPARZA®; Drug: Etoposide 100 mg/m^2; Etoposide 100 mg/m^2 intravenous (IV) Q3W, Day 1-3; Drug: Platinum, investigator's choice; Carboplatin titrated to an area under the plasma drug concentration time curve (AUC) of 5 mg/mL/min IV Q3W OR Cisplatin 75 mg/m^2 IV Q3W on Day 1 of each cycle; Radiation: Standard Thoracic Radiotherapy; Standard Thoracic Radiotherapy; Radiation: Prophylactic Cranial Irradiation (PCI); PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
Placebo Comparator: Group C (Pembrolizumab and Olaparib Matching Placebos); Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab placebo (saline) Q3W concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab placebo (saline) Q6W plus olaparib matching placebo for 12 months or until specific discontinuation criteria are met.	Drug: Pembrolizumab placebo (saline); Pembrolizumab placebo (saline) Q3W; Drug: Pembrolizumab placebo (saline); Pembrolizumab placebo (saline) Q6W; Drug: Olaparib matching placebo; Olaparib matching placebo BID; Drug: Etoposide 100 mg/m^2; Etoposide 100 mg/m^2 intravenous (IV) Q3W, Day 1-3; Drug: Platinum, investigator's choice; Carboplatin titrated to an area under the plasma drug concentration time curve (AUC) of 5 mg/mL/min IV Q3W OR Cisplatin 75 mg/m^2 IV Q3W on Day 1 of each cycle; Radiation: Standard Thoracic Radiotherapy; Standard Thoracic Radiotherapy; Radiation: Prophylactic Cranial Irradiation (PCI); PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.

Outcome Measures

Primary Outcome Measures :

1. Progression-free Survival Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); the time from randomization to progression or death due to any cause, whichever occurs first [ Time Frame: Up to approximately 59 months ]
   Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) is the time from randomization to progression or death due to any cause, whichever occurs first.
2. Overall Survival: the time from randomization to death due to any cause [ Time Frame: Up to approximately 82 months ]
   Overall Survival (OS) is the time from randomization to death due to any cause.

Secondary Outcome Measures :

1. Number of Participants Experiencing an Adverse Events (AEs) [ Time Frame: Up to approximately 82 months ]
   An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
2. Number of Participants Discontinuing Study Treatment Due to Adverse Events (AEs) [ Time Frame: Up to approximately 82 months ]
   An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
3. Objective Response (OR): Complete Response (CR) or Partial Response (PR) [ Time Frame: Up to approximately 82 months ]
   Percentage of participants in the analysis population who have a best overall response of either confirmed CR or a PR per RECIST 1.1.
4. Duration of Response (DOR): the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first [ Time Frame: Up to approximately 82 months ]
   DOR is the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first.
5. Change from Baseline at Cycle 1 in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 & 30) Scale Score [ Time Frame: Baseline and 82 months post randomization ]
   The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 scores will be presented.
6. Change from Baseline at Cycle 1 in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score [ Time Frame: Baseline and 82 months post randomization ]
   The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score will be presented.
7. Change from Baseline at Cycle 1 in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score [ Time Frame: Baseline and 82 months post randomization ]
   The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How was your chest pain?" are scored on a 4 point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score will be presented.
8. Change from Baseline at Cycle 1 in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score [ Time Frame: Baseline and 82 months post randomization ]
   The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 dyspnea (Item 8) score will be presented.
9. Change from Baseline at Cycle 1 in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score [ Time Frame: Baseline and 82 months post randomization ]
   The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented.
10. Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score [ Time Frame: Up to approximately 82 months post randomization ]
    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 Items 29 and 30 scale scores.
11. Time to True Deterioration (TTD) in Cough (LC13/Item 1) Scale Score [ Time Frame: Up to approximately 82 months post randomization ]
    The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in cough EORTC QLQLC13 cough (Item 1) scale score.
12. Time to True Deterioration (TTD) in Chest Pain (LC13/Item 10) Scale Score [ Time Frame: Up to approximately 82 months post randomization ]
    The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How was your chest pain?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-LC13 chest pain (Item 10) scale score.
13. Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score [ Time Frame: Up to approximately 82 months post randomization ]
    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 dyspnea (Item 8) scale score.
14. Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score [ Time Frame: Up to approximately 82 months post randomization ]
    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 physical functioning (Items 1 to 5) scale scores.
15. Objective Response (OR, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels [ Time Frame: Up to approximately 82 months ]
    Percentage of participants in the analysis population who have a best overall response of either confirmed CR or a PR per RECIST 1.1, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.
16. Duration of Response (DOR, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels [ Time Frame: Up to approximately 82 months ]
    DOR is the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.
17. Progression-free Survival (PFS, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels [ Time Frame: Up to approximately 59 months ]
    Progression-free Survival Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); the time from randomization to progression or death due to any cause, whichever occurs first, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.
18. Overall Survival (OS) assessed by programmed cell death ligand 1 (PD-L1) expression levels [ Time Frame: Up to approximately 82 months ]
    Overall Survival: the time from randomization to death due to any cause, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Has pathologically (histologically or cytologically) confirmed Small Cell Lung Cancer (SCLC).

   Note: Note: Participants with histology showing a mixed tumor with small cell and non-small cell elements are not eligible.

2. Has Limited-Stage SCLC (Stage I-III, by AJCC 8th Edition Cancer Staging), and can be safely treated with definitive radiation doses.
3. Has no evidence of metastatic disease by whole body positron emission tomography /computed tomography (PET/CT scan), CT or magnetic resonance imaging (MRI) scans
4. Has at least 1 lesion that meets the criteria for being measurable, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
5. Has not received prior treatment (chemotherapy or radiotherapy or surgery resection) of LS-SCLC.
6. Is not expected to require tumor resection during the course of the study.
7. Must submit a pre-treatment tumor tissue sample (formalin-fixed, paraffin embedded blocks are preferred to slides) including cytologic sample, if tissue sample unavailable.
8. Has Eastern Cooperative Oncology Group (ECOG) Performance score 0 or 1 assessed within 7 days prior to the first administration of study intervention.
9. Has a life expectancy of at least 6 months.
10. Has adequate organ function.
11. Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention.
12. Male and female participants who are at least 18 years of age at the time of signing the information consent.
13. Male participants must refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention.

14. Abstains from breastfeeding during the study intervention period and for at least the following period after the last study intervention:

    • Pembrolizumab: 120 days
    • Olaparib: 7 days

Exclusion Criteria:

1. Has history, current diagnosis, or features suggestive of myelodysplastic syndrome/ acute myeloid leukemia (MDS/AML).
2. Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PDL1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
3. Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
4. Had major surgery <4 weeks prior to the first dose of study intervention (except for placement of vascular access).
5. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
8. Has severe hypersensitivity (≥ Grade 3) to study intervention and/or any of its excipients.
9. Has an active autoimmune disease that has required systemic treatment in past 2 years
10. Has a history of (non-infectious) pneumonitis/interstitial lung disease that requires steroids
11. Has an active infection requiring systemic therapy.
12. Has a known history of human immunodeficiency virus (HIV) infection or Hepatitis B or known active Hepatitis C virus infection.

Contacts and Locations

Contacts

Contact: Toll Free Number; 1-888-577-8839; Trialsites@merck.com

Locations

United States, Arizona

Ironwood Cancer & Research Centers ( Site 0007); Recruiting

Chandler, Arizona, United States, 85224

Contact: Study Coordinator 480-398-7674

United States, California

Loma Linda University Cancer Center ( Site 0011); Recruiting

Loma Linda, California, United States, 92350

Contact: Study Coordinator 909-558-4050

United States, District of Columbia

Georgetown University ( Site 0017); Completed

Washington, District of Columbia, United States, 20007

United States, Indiana

Fort Wayne Medical Oncology and Hematology ( Site 0034); Recruiting

Fort Wayne, Indiana, United States, 46804

Contact: Study Coordinator 260-436-0800

United States, Kentucky

University of Kentucky Chandler Medical Center ( Site 0138); Recruiting

Lexington, Kentucky, United States, 40536

Contact: Study Coordinator 859-323-5000

United States, Louisiana

Overton Brooks VAMC ( Site 0041); Completed

Shreveport, Louisiana, United States, 71101

United States, Maryland

Harry & Jeanette Weinberg Cancer Institute ( Site 0045); Recruiting

Baltimore, Maryland, United States, 21237

Contact: Study Coordinator 443-777-7364

United States, Michigan

VA Ann Arbor Healthcare System ( Site 0050); Recruiting

Ann Arbor, Michigan, United States, 48105

Contact: Study Coordinator 734-769-7100

United States, Montana

St. Vincent Healthcare Frontier Cancer Center ( Site 0056); Completed

Billings, Montana, United States, 59102

United States, Nebraska

Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0061); Recruiting

Omaha, Nebraska, United States, 68130

Contact: Study Coordinator 308-398-5450

United States, New Jersey

Memorial Sloan Kettering - Basking Ridge ( Site 0133); Recruiting

Basking Ridge, New Jersey, United States, 07920

Contact: Study Coordinator 646-608-3793

John Theurer Cancer Center ( Site 0064); Completed

Hackensack, New Jersey, United States, 07601

Memorial Sloan Kettering - Monmouth ( Site 0135); Recruiting

Middletown, New Jersey, United States, 07748

Contact: Study Coordinator 848-225-6000

Memorial Sloan Kettering - Bergen ( Site 0130); Recruiting

Montvale, New Jersey, United States, 07645

Contact: Study Coordinator 646-608-3793

Rutgers Cancer Institute of New Jersey ( Site 0123); Recruiting

New Brunswick, New Jersey, United States, 08901

Contact: Study Coordinator 732-235-2465

United States, New York

Memorial Sloan Kettering- Commack ( Site 0132); Recruiting

Commack, New York, United States, 11725

Contact: Study Coordinator 646-608-3793

Memorial Sloan Kettering - Westchester-Thoracic Oncology ( Site 0134); Recruiting

Harrison, New York, United States, 10604

Contact: Study Coordinator 646-608-3793

Memorial Sloan Kettering Cancer Center ( Site 0069); Recruiting

New York, New York, United States, 10021

Contact: Study Coordinator 646-608-3793

Memorial Sloan Kettering - Nassau ( Site 0131); Recruiting

Uniondale, New York, United States, 11553

Contact: Study Coordinator 646-608-3793

United States, Ohio

Cleveland Clinic ( Site 0139); Recruiting

Cleveland, Ohio, United States, 44195

Contact: Study Coordinator 216-636-6888

United States, Pennsylvania

Penn State Hershey Cancer Institute ( Site 0081); Completed

Hershey, Pennsylvania, United States, 17033

United States, South Carolina

Saint Francis Cancer Center ( Site 0087); Completed

Greenville, South Carolina, United States, 29607

United States, Tennessee

The University of Tennessee Medical Center ( Site 0116); Recruiting

Knoxville, Tennessee, United States, 37920

Contact: Study Coordinator 865-305-4893

United States, Texas

Texas Oncology - Dallas (Presbyterian)_McIntyre ( Site 0098); Completed

Dallas, Texas, United States, 75231

Texas Oncology - Dallas (Sammons) ( Site 0093); Recruiting

Dallas, Texas, United States, 75246

Contact: Study Coordinator 214-826-9797

MD Anderson Cancer Center ( Site 0100); Recruiting

Houston, Texas, United States, 77030

Contact: Study Coordinator 844-215-4940

United States, Washington

Providence Regional Cancer Partnership ( Site 0106); Recruiting

Everett, Washington, United States, 98201

Contact: Study Coordinator 425-297-5577

Multicare Institute For Research And Innovation ( Site 0108); Completed

Tacoma, Washington, United States, 98405

Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0112); Recruiting

Yakima, Washington, United States, 98902

Contact: Study Coordinator 509-574-3400

Australia, New South Wales

Campbelltown Hospital ( Site 3002); Recruiting

Campbelltown, New South Wales, Australia, 2560

Contact: Study Coordinator +61246344300

Nepean Hospital ( Site 3001); Recruiting

Kingswood, New South Wales, Australia, 2747

Contact: Study Coordinator +61247343500

Calvary Mater Newcastle ( Site 3000); Recruiting

Waratah, New South Wales, Australia, 2298

Contact: Study Coordinator +61240143282

Australia, Queensland

Gold Coast University Hospital ( Site 3003); Recruiting

Southport, Queensland, Australia, 4215

Contact: Study Coordinator +61756870000

Australia, Victoria

Frankston Hospital-Oncology and Haematology ( Site 3007); Recruiting

Frankston, Victoria, Australia, 3199

Contact: Study Coordinator +61397847175

Austin Health-Austin Hospital ( Site 3006); Recruiting

Heidelberg, Victoria, Australia, 3084

Contact: Study Coordinator +61394969863

Western Health-Sunshine Hospital ( Site 3004); Recruiting

St Albans, Victoria, Australia, 3021

Contact: Study Coordinator +61385959167

Belgium

Saint-Luc UCL ( Site 1005); Recruiting

Brussels, Bruxelles-Capitale, Region De, Belgium, 1200

Contact: Study Coordinator +3227642833

Grand Hopital de Charleroi ( Site 1003); Recruiting

Charleroi, Hainaut, Belgium, 6000

Contact: Study Coordinator +3271104766

C.I.U. Hopital Ambroise Pare ( Site 1001); Recruiting

Mons, Hainaut, Belgium, 7000

Contact: Study Coordinator +3265413746

CHU UCL Namur Site de Godinne ( Site 1004); Recruiting

Yvoir, Namur, Belgium, 5530

Contact: Study Coordinator +3281422111

UZ Leuven ( Site 1002); Recruiting

Leuven, Vlaams-Brabant, Belgium, 3000

Contact: Study Coordinator +3216346802

AZ Delta ( Site 1000); Recruiting

Roeselare, West-Vlaanderen, Belgium, 8800

Contact: Study Coordinator +3251237216

Bulgaria

MHAT "Uni Hospital" OOD ( Site 2507); Recruiting

Panagyurishte, Pazardzhik, Bulgaria, 4500

Contact: Study Coordinator 00359885797096

Canada, Alberta

Cross Cancer Institute ( Site 0206); Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Contact: Study Coordinator 7804328762

Canada, Ontario

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0212); Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Contact: Study Coordinator 905-387-9495

Canada, Quebec

CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0202); Recruiting

Montreal, Quebec, Canada, H3T 1M5

Contact: Study Coordinator 5143453511 x6734

McGill University Health Centre ( Site 0210); Recruiting

Montréal, Quebec, Canada, H4A 3J1

Contact: Study Coordinator 5149341934 ext38930

CIUSSS de la Mauricie et du Centre du Quebec ( Site 0200); Recruiting

Trois-Rivieres, Quebec, Canada, G8Z 3R9

Contact: Study Coordinator 8196973333

China, Beijing

Peking Union Medical College Hospital ( Site 3102); Recruiting

Beijing, Beijing, China, 100006

Contact: Study Coordinator +86 10 69156114

Cancer Hospital Chinese Academy of Medical Sciences ( Site 3104); Active, not recruiting

Beijing, Beijing, China, 100021

Beijing Cancer Hospital ( Site 3127); Recruiting

Beijing, Beijing, China, 100142

Contact: Study Coordinator 13701224460

Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 3140); Active, not recruiting

Beijing, Beijing, China, 100142

China, Chongqing

Chongqing Cancer Hospital ( Site 3135); Active, not recruiting

Chongqing, Chongqing, China, 400030

Daping Hospital,Third Military Medical University ( Site 3136); Active, not recruiting

Chongqing, Chongqing, China, 400042

China, Fujian

Fujian Provincial Cancer Hospital ( Site 3126); Recruiting

Fuzhou, Fujian, China, 350014

Contact: Study Coordinator +8613906900190

The First Affiliated Hospital of Xiamen University ( Site 3121); Recruiting

Xiamen, Fujian, China, 361003

Contact: Study Coordinator 8613806000926

China, Guangdong

Peking University Shenzhen Hospital ( Site 3118); Recruiting

Shenzhen, Guangdong, China, 518036

Contact: Study Coordinator +8613823394076

Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3113); Recruiting

Shenzhen, Guangdong, China, 518116

Contact: Study Coordinator 0755-66619602

China, Henan

Henan Cancer Hospital ( Site 3105); Recruiting

Zhengzhou, Henan, China, 450008

Contact: Study Coordinator 865512922342

China, Hubei

Wuhan Union Hospital ( Site 3123); Active, not recruiting

Wuhan, Hubei, China, 430022

Tongji Medical College Huazhong University of Science and Technology ( Site 3138); Completed

Wuhan, Hubei, China, 430030

Hubei Cancer Hospital ( Site 3120); Recruiting

Wuhan, Hubei, China, 430079

Contact: Study Coordinator 027-87670138

China, Hunan

Hunan Cancer Hospital ( Site 3133); Recruiting

Changsha, Hunan, China, 410006

Contact: Study Coordinator 8613973135460

Xiangya Hospital of Central South University ( Site 3137); Active, not recruiting

Changsha, Hunan, China, 410008

Second Xiangya Hospital of Central-South University ( Site 3128); Recruiting

Changsha, Hunan, China, 410011

Contact: Study Coordinator 0731-85292097

China, Jiangsu

Jiangsu Cancer Hospital ( Site 3139); Recruiting

Nanjing, Jiangsu, China, 210000

Contact: Study Coordinator +8613913909043

China, Jiangxi

The Second Affiliated Hospital of Nanchang University ( Site 3106); Recruiting

Nanchang, Jiangxi, China, 330006

Contact: Study Coordinator 8613767120022

China, Jilin

The First Hospital of Jilin University ( Site 3132); Active, not recruiting

Changchun, Jilin, China, 130021

China, Shandong

Shandong Province Cancer Hospital ( Site 3100); Recruiting

Jinan, Shandong, China, 250117

Contact: Study Coordinator 0531-67627107

China, Shanghai

Shanghai Chest Hospital ( Site 3107); Active, not recruiting

Shangai, Shanghai, China, 200030

Shanghai Pulmonary Hospital ( Site 3101); Recruiting

Shanghai, Shanghai, China, 200443

Contact: Study Coordinator 02165115006

China, Sichuan

West China Hospital of Sichuan University ( Site 3114); Active, not recruiting

Chengdu, Sichuan, China, 510115

China, Tianjin

Tianjin Medical University Cancer Institute & Hospital ( Site 3103); Active, not recruiting

Tianjin, Tianjin, China, 300060

China, Zhejiang

Hangzhou Cancer Hospital ( Site 3129); Recruiting

Hanghzou, Zhejiang, China, 310002

Contact: Study Coordinator 18857110928

The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3131); Recruiting

Hangzhou, Zhejiang, China, 310003

Contact: Study Coordinator +8613957162839

Zhejiang Cancer Hospital.... ( Site 3108); Recruiting

Hangzhou, Zhejiang, China, 310022

Contact: Study Coordinator 0571-88122261

Estonia

SA Pohja-Eesti Regionaalhaigla ( Site 2201); Completed

Tallinn, Harjumaa, Estonia, 13419

SA Tartu Ulikooli Kliinikum ( Site 2200); Recruiting

Tartu, Tartumaa, Estonia, 51014

Contact: Study Coordinator +3735513443

France

C.H. de Saint Quentin ( Site 1111); Recruiting

Saint Quentin, Aisne, France, 02321

Contact: Study Coordinator +33360125235

CHU de Bordeaux Hop St ANDRE ( Site 1115); Recruiting

Bordeaux, Aquitaine, France, 33075

Contact: Study Coordinator 33556795808

Clinique Clairval ( Site 1108); Recruiting

Marseille, Bouches-du-Rhone, France, 13009

Contact: Study Coordinator 0033496196230

Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1105); Recruiting

Paris, Ile-de-France, France, 75014

Contact: Study Coordinator +33158413091

CHU Grenoble -Hop Michallon ( Site 1102); Recruiting

Grenoble, Isere, France, 38043

Contact: Study Coordinator +33476767575

Institut De Cancerologie De L Ouest ( Site 1110); Recruiting

Saint Herblain, Loire-Atlantique, France, 44805

Contact: Study Coordinator +33240679821

Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1103); Recruiting

Angers, Maine-et-Loire, France, 49000

Contact: Study Coordinator +33241352739

Hopital Avicenne ( Site 1106); Completed

Bobigny, Seine-Saint-Denis, France, 93000

H.I.A. Sainte-Anne ( Site 1101); Recruiting

Toulon, Var, France, 83800

Contact: Study Coordinator +33483162916

Greece

Henry Dunant Hospital ( Site 1205); Recruiting

Athens, Attiki, Greece, 115 26

Contact: Study Coordinator +306983519989

Sotiria Regional Chest Diseases Hospital of Athens ( Site 1200); Recruiting

Athens, Attiki, Greece, 115 27

Contact: Study Coordinator +302107700220

University General Hospital of Herakleion ( Site 1202); Recruiting

Heraklion, Irakleio, Greece, 711 10

Contact: Study Coordinator 302810392750

Anti-Cancer Hospital of Thessaloniki Theagenio ( Site 1204); Completed

Thessaloniki, Kentriki Makedonia, Greece, 54007

University General Hospital of Larisa ( Site 1201); Recruiting

Larissa, Thessalia, Greece, 411 10

Contact: Study Coordinator +302413502027

Hungary

Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1306); Recruiting

Kecskemét, Bacs-Kiskun, Hungary, 6000

Contact: Study Coordinator 003676519853

Petz Aladar Megyei Oktato Korhaz ( Site 1312); Recruiting

Gyor, Gyor-Moson-Sopron, Hungary, 9024

Contact: Study Coordinator +3696507900

Törökbálinti Tüdőgyógyintézet ( Site 1304); Recruiting

Torokbalint, Pest, Hungary, 2045

Contact: Study Coordinator +3623511570

Orszagos Koranyi Pulmonologiai Intezet ( Site 1301); Recruiting

Budapest, Hungary, 1121

Contact: Study Coordinator 0036205651900

Orszagos Onkologiai Intezet ( Site 1310); Recruiting

Budapest, Hungary, 1122

Contact: Study Coordinator +3612248600

Uzsoki Utcai Korhaz ( Site 1303); Completed

Budapest, Hungary, 1145

Israel

Rambam Health Care Campus-Oncology Division ( Site 1401); Recruiting

Haifa, Israel, 3109601

Contact: Study Coordinator +97247776700

Chaim Sheba Medical Center ( Site 1400); Recruiting

Ramat Gan, Israel, 5262000

Contact: Study Coordinator +97235307096

Italy

A O U Policlinico di Modena ( Site 1503); Recruiting

Modena, Emilia-Romagna, Italy, 41124

Contact: Study Coordinator +39 3381446063

Azienda Ospedaliero Universitaria Careggi ( Site 1509); Recruiting

Florence, Firenze, Italy, 50134

Contact: Study Coordinator +393209225506

IRCCS Ospedale San Raffaele ( Site 1500); Recruiting

Milano, Italy, 20132

Contact: Study Coordinator 390226436627

Istituto Nazionale dei Tumori ( Site 1504); Recruiting

Milano, Italy, 20133

Contact: Study Coordinator +390223903813

Istituto Europeo di Oncologia ( Site 1501); Recruiting

Milano, Italy, 20141

Contact: Study Coordinator +390257489440

IRCCS Istituto Oncologico Veneto ( Site 1506); Recruiting

Padova, Italy, 35128

Contact: Study Coordinator +39 3923633461

Policlinico Universitario Agostino Gemelli ( Site 1505); Recruiting

Roma, Italy, 00168

Contact: Study Coordinator +390630155202

Japan

Aichi Cancer Center Hospital ( Site 4010); Recruiting

Nagoya, Aichi, Japan, 464-8681

Contact: Study Coordinator +81-52-762-6111

Kobe Minimally Invasive Cancer Center ( Site 4003); Recruiting

Kobe, Hyogo, Japan, 650-0046

Contact: Study Coordinator +81-78-304-4100

Takarazuka City Hospital ( Site 4013); Recruiting

Takarazuka, Hyogo, Japan, 665-0827

Contact: Study Coordinator +81-797-87-1161

Kanagawa Cancer Center ( Site 4001); Recruiting

Yokohama, Kanagawa, Japan, 241-8515

Contact: Study Coordinator +81-45-520-2222

Kansai Medical University Hospital ( Site 4009); Recruiting

Hirakata, Osaka, Japan, 573-1191

Contact: Study Coordinator +81-72-804-0101

Osaka Medical and Pharmaceutical University Hospital ( Site 4007); Recruiting

Takatsuki, Osaka, Japan, 5698686

Contact: Study Coordinator +81-72-683-1221

Shizuoka Cancer Center ( Site 4014); Recruiting

Nagaizumi, Shizuoka, Japan, 411-8777

Contact: Study Coordinator +81559895222

National Hospital Organization Kyushu Cancer Center ( Site 4000); Recruiting

Fukuoka, Japan, 811-1395

Contact: Study Coordinator +81-92-541-3231

Niigata Cancer Center Hospital ( Site 4004); Recruiting

Niigata, Japan, 951-8566

Contact: Study Coordinator +81-25-266-5111

Okayama University Hospital ( Site 4012); Recruiting

Okayama, Japan, 7008558

Contact: Study Coordinator +81-86-223-7151

Osaka International Cancer Institute ( Site 4005); Recruiting

Osaka, Japan, 541-8567

Contact: Study Coordinator +81-6-6945-1181

National Cancer Center Hospital ( Site 4015); Recruiting

Tokyo, Japan, 104-0045

Contact: Study Coordinator +81-3-3542-2511

Juntendo University Hospital ( Site 4008); Recruiting

Tokyo, Japan, 113-0033

Contact: Study Coordinator +81-3-3813-3111

Tokyo Metropolitan Komagome Hospital ( Site 4011); Recruiting

Tokyo, Japan, 113-8677

Contact: Study Coordinator +81-3-3823-2101

The Cancer Institute Hospital of JFCR ( Site 4006); Recruiting

Tokyo, Japan, 135-8550

Contact: Study Coordinator +81-3-3520-0111

Showa University Hospital ( Site 4002); Recruiting

Tokyo, Japan, 142-8666

Contact: Study Coordinator +81-3-3784-8000

Korea, Republic of

National Cancer Center ( Site 3306); Recruiting

Goyang-si, Kyonggi-do, Korea, Republic of, 10408

Contact: Study Coordinator +82319201694

Seoul National University Bundang Hospital ( Site 3301); Recruiting

Seongnam-si, Kyonggi-do, Korea, Republic of, 13620

Contact: Study Coordinator +82317877003

The Catholic University of Korea St. Vincent s Hospital ( Site 3303); Recruiting

Suwon-si, Kyonggi-do, Korea, Republic of, 16247

Contact: Study Coordinator +82312498153

Inje University Haeundae Paik Hospital ( Site 3307); Recruiting

Busan, Pusan-Kwangyokshi, Korea, Republic of, 48108

Contact: Study Coordinator +82517970008

Asan Medical Center ( Site 3308); Recruiting

Songpagu, Seoul, Korea, Republic of, 05505

Contact: Study Coordinator +82230105935

Keimyung University Dongsan Hospital ( Site 3302); Completed

Daegu, Taegu-Kwangyokshi, Korea, Republic of, 42601

Severance Hospital Yonsei University Health System ( Site 3304); Recruiting

Seoul, Korea, Republic of, 03722

Contact: Study Coordinator +82222288126

Samsung Medical Center ( Site 3300); Recruiting

Seoul, Korea, Republic of, 06351

Contact: Study Coordinator +82234101795

Lithuania

Nacionalinis Vezio Institutas ( Site 2300); Recruiting

Vilnius, Vilniaus Miestas, Lithuania, 08406

Contact: Study Coordinator +37052786748

LSMUL Kauno Klinikos ( Site 2301); Recruiting

Kaunas, Lithuania, 50161

Contact: Study Coordinator +37037326457

Mexico

Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0401); Recruiting

Guadalajara, Jalisco, Mexico, 44280

Contact: Study Coordinator 523315145351

Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0404); Recruiting

Monterrey, Nuevo Leon, Mexico, 64460

Contact: Study Coordinator +528183338111

Portugal

Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 1705); Recruiting

Lisboa, Portugal, 1099-023

Contact: Study Coordinator +351217229800

Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 1701); Recruiting

Porto, Portugal, 4200-072

Contact: Study Coordinator +351225084000

Romania

Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2805); Recruiting

Florești, Cluj, Romania, 407280

Contact: Study Coordinator +40742206212

Spitalul Municipal Ploiesti ( Site 2801); Recruiting

Ploiesti, Prahova, Romania, 100337

Contact: Study Coordinator +40740062630

Cabinet Medical Oncomed ( Site 2802); Recruiting

Timisoara, Timis, Romania, 300239

Contact: Study Coordinator +40256495403

S.C.Focus Lab Plus S.R.L ( Site 2804); Recruiting

Bucuresti, Romania, 022548

Contact: Study Coordinator +40721298677

Russian Federation

Moscow Regional Oncological Dispensary-Oncology (thoracic surgery) Department №1 ( Site 1815); Suspended

Balashikha, Moskovskaya Oblast, Russian Federation, 143900

Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 1812); Suspended

Moscow, Moskva, Russian Federation, 105094

MROI n.a. P.A. Herzen - branch of FSBI NMICR of MoH of Russia ( Site 1800); Suspended

Moscow, Moskva, Russian Federation, 125284

Nizhniy Novgorod Region Oncology Dispensary ( Site 1811); Completed

Nizhny Novgorod, Nizhegorodskaya Oblast, Russian Federation, 603081

Omsk Clinical Oncology Dispensary ( Site 1806); Completed

Omsk, Omskaya Oblast, Russian Federation, 644013

Sverdlovsk Regional Oncology Hospital ( Site 1807); Suspended

Ekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620036

Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1814); Suspended

Kazan, Tatarstan, Respublika, Russian Federation, 420029

Serbia

Institute for Oncology and Radiology of Serbia ( Site 2995); Recruiting

Belgrade, Beograd, Serbia, 11000

Contact: Study Coordinator 381641379926

Institut za plucne bolesti Vojvodine Sremska Kamenica ( Site 2991); Recruiting

Sremska Kamenica, Sremski Okrug, Serbia, 21204

Contact: Study Coordinator 381642636187

South Africa

Steve Biko Academic Hospital ( Site 5000); Recruiting

Pretoria, Gauteng, South Africa, 0002

Contact: Study Coordinator +27123466701

Groote Schuur Hospital ( Site 5002); Recruiting

Cape Town, Western Cape, South Africa, 7925

Contact: Study Coordinator +27214044266

Spain

Hospital Universitario Central de Asturias ( Site 1900); Recruiting

Oviedo, Asturias, Spain, 33011

Contact: Study Coordinator 34985106100x39705

Hospital Duran i Reynals ( Site 1903); Recruiting

Hospitalet de Llobregat, Barcelona, Spain, 08908

Contact: Study Coordinator +34932607744

Hospital Universitari Vall d Hebron ( Site 1904); Recruiting

Barcelona, Spain, 08035

Contact: Study Coordinator +34934894158

Hospital Universitario 12 de Octubre ( Site 1902); Recruiting

Madrid, Spain, 28041

Contact: Study Coordinator +34914692313

Hospital Regional Universitario de Malaga ( Site 1905); Recruiting

Malaga, Spain, 29010

Contact: Study Coordinator +34951291425

Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1907); Recruiting

Sevilla, Spain, 41009

Contact: Study Coordinator +34955926578

Turkey

Ankara Sehir Hastanesi ( Site 2007); Recruiting

Ankara, Turkey, 06800

Contact: Study Coordinator +905555306271

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2009); Recruiting

Istanbul, Turkey, 34098

Contact: Study Coordinator +905324167355

Medipol Universite Hastanesi ( Site 2005); Recruiting

Istanbul, Turkey, 34214

Contact: Study Coordinator +905325280486

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2003); Recruiting

Istanbul, Turkey, 34722

Contact: Study Coordinator +905063509061

Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001); Recruiting

Izmir, Turkey, 35040

Contact: Study Coordinator +905322202675

Ukraine

Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107); Suspended

Dnipro, Dnipropetrovska Oblast, Ukraine, 49055

Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2110); Suspended

Kharkiv, Kharkivska Oblast, Ukraine, 61024

Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104); Suspended

Kapitanivka Village, Kyivska Oblast, Ukraine, 08111

Clinic of National Cancer Institute ( Site 2101); Suspended

Kyiv, Kyivska Oblast, Ukraine, 03022

Medical Center Verum ( Site 2106); Completed

Kyiv, Kyivska Oblast, Ukraine, 03039

LISOD. Hospital ( Site 2111); Suspended

Pliuty, Kyiv, Ukraine, 08720

Kyiv City Clinical Oncology Center ( Site 2100); Suspended

Kyiv, Ukraine, 03115

United Kingdom

Royal Infirmary Aberdeen ( Site 2403); Recruiting

Aberdeen, Aberdeen City, United Kingdom, AB25 2ZN

Contact: Study Coordinator 03454566000

Ninewells Hospital and Medical School ( Site 2401); Recruiting

Dundee, Dundee City, United Kingdom, DD1 9SY

Contact: Study Coordinator 01382 435543

Taunton and Somerset Hospital ( Site 2404); Recruiting

Taunton, England, United Kingdom, TA1 5DA

Contact: Study Coordinator 01823333444

Barts Health NHS Trust ( Site 2409); Recruiting

London, London, City Of, United Kingdom, EC1A 7BE

Contact: Study Coordinator +447779785642

Guy s & St Thomas NHS Foundation Trust ( Site 2408); Recruiting

London, London, City Of, United Kingdom, SE1 9RT

Contact: Study Coordinator +442071887188

The Christie NHS Foundation Trust ( Site 2405); Recruiting

Manchester, United Kingdom, M20 4GJ

Contact: Study Coordinator 0161 446 3745

Sponsors and Collaborators

Merck Sharp & Dohme LLC

Investigators

• Study Director: Medical Director, MD; Merck Sharp & Dohme LLC

More Information

Additional Information:

Merck Oncology Clinical Trials Information 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rimner A, Lai WV, Califano R, Jabbour SK, Rudin CM, Faivre-Finn C, Cho BC, Kato T, Yu J, Chafin W, Yu L, Zhao B, Byers L. Rationale and Design of the Phase 3 KEYLYNK-013 Study of Pembrolizumab With Concurrent Chemoradiotherapy Followed by Pembrolizumab With or Without Olaparib for Limited-Stage Small-Cell Lung Cancer. Clin Lung Cancer. 2022 Jul;23(5):e325-e329. doi: 10.1016/j.cllc.2022.04.005. Epub 2022 Apr 29.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT04624204
• Other Study ID Numbers: 7339-013; MK-7339-013 ( Other Identifier: Merck Protocol Number ); jRCT2031200296 ( Registry Identifier: jRCT ); 2019-003616-31 ( EudraCT Number )
• First Posted: November 10, 2020
• Last Update Posted: June 8, 2023
• Last Verified: June 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Merck Sharp & Dohme LLC:

Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1); Pembrolizumab; Olaparib

Additional relevant MeSH terms:

Lung Neoplasms; Small Cell Lung Carcinoma; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pembrolizumab; Etoposide; Olaparib; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immune Checkpoint Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Poly(ADP-ribose) Polymerase Inhibitors