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Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006/KEYVIBE-006)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05298423
Recruitment Status : Recruiting
First Posted : March 28, 2022
Last Update Posted : September 28, 2022
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Brief Summary:

This study is to evaluate the safety and efficacy of pembrolizumab/vibostolimab (MK-7684A) in combination with concurrent chemoradiotherapy (cCRT) followed by pembrolizumab/vibostolimab versus cCRT followed by durvalumab in participants with unresectable, locally advanced, stage III Non-small Cell Lung Cancer (NSCLC). The primary hypotheses are that pembrolizumab/vibostolimab with cCRT followed by pembrolizumab/vibostolimab is superior to cCRT followed by durvalumab with respect to the following:

  • progression free survival (PFS) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) in participants with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% and PD-L1 all comer participants.
  • overall survival (OS) in participants with PD-L1 TPS ≥1% and PD-L1 all comer participants.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Biological: pembrolizumab/vibostolimab Biological: durvalumab Drug: cisplatin Drug: pemetrexed Drug: etoposide Drug: carboplatin Drug: paclitaxel Radiation: thoracic radiotherapy Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 784 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab With Pembrolizumab) in Combination With Concurrent Chemoradiotherapy Followed by MK-7684A Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III NSCLC
Actual Study Start Date : May 3, 2022
Estimated Primary Completion Date : September 1, 2028
Estimated Study Completion Date : September 4, 2029

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: pembrolizumab/vibostolimab coformulation+chemotherapy+radiotherapy
For the first 3 cycles, participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) intravenously (IV) on Day 1 plus 3 cycles of investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray [Gy] in 2 Gy fractions for 30 days total) during Cycles 2, 3. Participants receive pembrolizumab/vibostolimab for Cycles 4-20 or until discontinuation (up to ~14 months). Cycles 1-20 are 21-day cycles. Investigator's choice of chemotherapy: cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of Cycles 1-3 for non-squamous histology only; cisplatin 50 mg/m^2 on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3 and etoposide 50 mg/m^2 on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3 and paclitaxel 200 mg/m^2 on Day 1 of Cycle 1 and 45 mg/m^2 on Days 1, 8, 15 of Cycles 2-3.
Biological: pembrolizumab/vibostolimab
Administered as an intravenous (IV) infusion
Other Name: MK-7684A

Drug: cisplatin
Administered as an IV infusion
Other Name: PLATINOL-AQ®

Drug: pemetrexed
Administered as an IV infusion
Other Name: ALIMTA®

Drug: etoposide
Administered as an IV infusion
Other Name: TOPOSAR®

Drug: carboplatin
Administered as an IV infusion
Other Name: PARAPLATIN®

Drug: paclitaxel
Administered as an IV infusion
Other Name: TAXOL®

Radiation: thoracic radiotherapy
Administered as an external beam radiation

Active Comparator: chemotherapy+radiotherapy+durvalumab

For the first 3 cycles, participants will receive investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy in 2 Gy fractions for 30 days total) during Cycles 2 and 3. Following cCRT, participants receive durvalumab 10 mg/kg every 2 weeks for up to an additional 26 cycles or until discontinuation (up to approximately 14 months). cCRT Cycles 1-3=21-day cycles; durvalumab Cycles 1-26=14-day cycles.

Investigator's choice of chemotherapy: cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of Cycles 1-3 for non-squamous histology only; cisplatin 50 mg/m^2 on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3 and etoposide 50 mg/m^2 on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3 and paclitaxel 200 mg/m^2 on Day 1 of Cycle 1 and 45 mg/m^2 on Days 1, 8, 15 of Cycles 2-3.

Biological: durvalumab
Administered as an IV infusion
Other Name: IMFINZI®

Drug: cisplatin
Administered as an IV infusion
Other Name: PLATINOL-AQ®

Drug: pemetrexed
Administered as an IV infusion
Other Name: ALIMTA®

Drug: etoposide
Administered as an IV infusion
Other Name: TOPOSAR®

Drug: carboplatin
Administered as an IV infusion
Other Name: PARAPLATIN®

Drug: paclitaxel
Administered as an IV infusion
Other Name: TAXOL®

Radiation: thoracic radiotherapy
Administered as an external beam radiation




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) For All Participants [ Time Frame: Up to approximately 55 months ]
    PFS is defined as the time from randomization to the first documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. PFS per RECIST 1.1 will be assessed by blinded independent central review (BICR).

  2. Progression-Free Survival (PFS) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% [ Time Frame: Up to approximately 55 months ]
    PFS is defined as the time from randomization to the first documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. PFS per RECIST 1.1 will be assessed by blinded independent central review (BICR).

  3. Overall Survival (OS) For All Participants [ Time Frame: Up to approximately 75 months ]
    OS is defined as the time from randomization to death due to any cause.

  4. Overall Survival (OS) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% [ Time Frame: Up to approximately 75 months ]
    OS is defined as the time from randomization to death due to any cause.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) For All Participants [ Time Frame: Up to approximately 75 months ]
    ORR is defined as the percentage of participants who have a best response of confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). CR or PR by RECIST 1.1 will be assessed by blinded independent central review (BICR).

  2. Objective Response Rate (ORR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% [ Time Frame: Up to approximately 75 months ]
    ORR is defined as the percentage of participants who have a best response of confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). CR or PR by RECIST 1.1 will be assessed by blinded independent central review (BICR).

  3. Number of Participants Who Experience at Least One Adverse Event (AE) [ Time Frame: Up to approximately 75 months ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

  4. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) [ Time Frame: Up to approximately 75 months ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

  5. Duration of Response (DOR) For All Participants [ Time Frame: Up to approximately 75 months ]
    Duration of Response (DOR) is the time from first documented evidence of Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) until progressive disease (PD) or death. DOR per RECIST 1.1 will be assessed by blinded independent central review (BICR).

  6. Duration of Response (DOR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% [ Time Frame: Up to approximately 75 months ]
    Duration of Response (DOR) is the time from first documented evidence of Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) until progressive disease (PD) or death. DOR per RECIST 1.1 will be assessed by blinded independent central review (BICR).

  7. Change from Baseline in the Global Health Status /Quality of Life Items 29 and 30 Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) For All Participants [ Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization) ]
    The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL 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.

  8. Change from Baseline in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1% [ Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization) ]
    The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL 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.

  9. Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants [ Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization) ]
    The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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, with a higher score indicating a better quality of life.

  10. Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1% [ Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization) ]
    The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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, with a higher score indicating a better quality of life.

  11. Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) For All Participants [ Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization) ]
    The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" 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 more frequent coughing.

  12. Change from Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1% [ Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization) ]
    The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" 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 more frequent coughing.

  13. Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants [ Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization) ]
    The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" 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 more chest pain.

  14. Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1% [ Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization) ]
    The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" 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 more chest pain.

  15. Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants [ Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization) ]
    The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. 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 higher score indicates a worse level of dyspnea.

  16. Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1% [ Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization) ]
    The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. 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 higher score indicates a worse level of dyspnea.

  17. Time to True Deterioration (TTD) in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For All Participants [ Time Frame: Up to approximately 75 months post randomization ]
    The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL 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 outcome. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.

  18. Time to True Deterioration (TTD) in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1% [ Time Frame: Up to approximately 75 months post randomization ]
    The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL 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 outcome. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.

  19. Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants [ Time Frame: Up to approximately 75 months post randomization ]
    The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 level of function. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.

  20. Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1% [ Time Frame: Up to approximately 75 months post randomization ]
    The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 level of function. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.

  21. Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For All Participants [ Time Frame: Up to approximately 75 months post randomization ]
    The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" 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 more frequent coughing. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.

  22. Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1% [ Time Frame: Up to approximately 75 months post randomization ]
    The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" 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 more frequent coughing. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.

  23. Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants [ Time Frame: Up to approximately 75 months post randomization ]
    The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" 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 more chest pain. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.

  24. Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1% [ Time Frame: Up to approximately 75 months post randomization ]
    The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" 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 more chest pain. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.

  25. Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants [ Time Frame: Up to approximately 75 months post randomization ]
    The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. 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 higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.

  26. Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1% [ Time Frame: Up to approximately 75 months post randomization ]
    The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. 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 higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria

  • Has pathologically (histologically or cytologically) confirmed diagnosis of NSCLC.
  • Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8
  • Is determined to have unresectable, Stage III NSCLC as documented by a multidisciplinary tumor board or by the treating physician in consultation with a thoracic surgeon
  • Has no evidence of metastatic disease, indicating Stage IV NSCLC, in whole-body fluorodeoxyglucose (FDG)-positron emission tomography (PET) or FDG-PET/ computed tomography (CT) and CT or magnetic resonance imaging (MRI) scans of diagnostic quality of chest, abdomen, pelvis and brain
  • Has measurable disease as defined by RECIST 1.1, with at least 1 lesion being appropriate for selection as a target lesion, as determined by local site investigator/radiology review
  • Has not received prior treatment (chemotherapy, targeted therapy, or radiotherapy) for their Stage III NSCLC
  • Has provided tumor tissue sample (tissue biopsy [core, incisional, or excisional])
  • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 assessed within 7 days prior to the first administration of study intervention
  • Has a life expectancy of at least 6 months

Exclusion Criteria

  • Has small cell lung cancer (SCLC) or tumors with the presence of small cell elements. Mixed squamous/nonsquamous tumors are eligible
  • Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer
  • Has received major surgery (with the exception of replacement of vascular access) within 4 weeks before randomization. If the participant had a major operation, the participant must have recovered adequately from the procedure and/or any complications from the operation before starting study intervention
  • Is expected to require any other form of antineoplastic therapy, while on study
  • Has received colony-stimulating factors (e.g., Granulocyte Colony-Stimulating Factor [G-CSF], Granulocyte Macrophage Colony-Stimulating Factor [GM-CSF], or recombinant erythropoietin) within 28 days prior to the first dose of study intervention
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
  • 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 to the first dose of study medication
  • Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV ribonucleic acid [RNA] qualitative is detected) infection
  • Has had an allogenic tissue/solid organ transplant

Pemetrexed-specific Criteria:

  • Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed
  • Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05298423


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

Locations
Show Show 45 study locations
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
Additional Information:
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT05298423    
Other Study ID Numbers: 7684A-006
MK-7684A-006 ( Other Identifier: Merck )
KEYVIBE-006 ( Other Identifier: Merck )
jRCT2021220015 ( Registry Identifier: jRCT )
2021-005135-23 ( EudraCT Number )
First Posted: March 28, 2022    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: September 2022
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

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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 Cell Death 1 Ligand 1 (PDL1, PD-L1)
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Etoposide
Cisplatin
Carboplatin
Pembrolizumab
Pemetrexed
Durvalumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors