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Adjuvant Pembrolizumab in N2 Positive Non-small Cell Lung Cancer Patients

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ClinicalTrials.gov Identifier: NCT03053856
Recruitment Status : Not yet recruiting
First Posted : February 15, 2017
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
Myung-Ju Ahn, Samsung Medical Center

Brief Summary:

This is a single arm, single center phase II study of adjuvant pembrolizumab in N2 positive non-small cell lung cancer (NSCLC) patients treated with neoadjuvant concurrent chemoradiotherapy followed by curative resection. Patients will receive pembrolizumab 200 mg every 3 weeks for up to 24 months.

The primary objective of this study is to assess the efficacy of adjuvant pembrolizumab treatment in terms of disease-free survival (DFS; per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by the investigator).

The baseline assessment is part of the screening procedures and should be performed within 0 to 14 days before the start of study drug. The imaging modalities used for RECIST 1.1 assessment will be CT of chest or PET-CT if indicated. Follow-up chest CT for all patients will be assessed every 12 weeks for the first year, every 16 weeks for the second year, every 6 months for the third year, and every year thereafter. In subjects who discontinued study therapy without documented recurrence, every effort should be made to continue monitoring their disease status.

If an unscheduled assessment is performed, and the patient has not progressed, every attempt should be made to perform the subsequent assessments at their scheduled visits. RECIST 1.1 scans will be analyzed by the investigator on site; a central review will not be conducted.

Following completion or discontinuation of study drug, patients will enter a follow-up period.

Once a patient has had objective relapse recorded and has discontinued study drug, the patient will be followed for survival status every 3 months until death, withdrawal of consent or the end of the study.

Patients will also be requested to provide tumor samples from diagnostic (obtained before neoadjuvant CCRT) and surgical specimens for exploratory biomarker study. Sample provision is not optional, subject to a specific consent.


Condition or disease Intervention/treatment Phase
Stage IIIA Non-small Cell Lung Cancer Drug: Pembrolizumab Procedure: Curative resection Procedure: Neoadjuvant concurrent chemoradiotherapy Drug: Cisplatin Drug: Paclitaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Intervention Model Description: N2 positive stage IIIA non-small cell lung cancer treated with neoadjuvant concurrent chemoradiotherapy followed by curative resection
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Single-arm Study of Adjuvant Pembrolizumab in N2 Positive Non-small Cell Lung Cancer Treated With Neoadjuvant Concurrent Chemoradiotherapy Followed by Curative Resection
Estimated Study Start Date : February 14, 2017
Estimated Primary Completion Date : May 13, 2021
Estimated Study Completion Date : August 13, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Pembrolizumab arm
Adjuvant Pembrolizumab
Drug: Pembrolizumab
Adjuvant pembrolizumab 200 mg every 3 weeks for up to 24 months. (treated with neoadjuvant concurrent chemoradiotherapy followed by curative resection)
Other Name: MK-3475

Procedure: Curative resection
Neoadjuvant concurrent chemoradiotherapy followed by curative resection

Procedure: Neoadjuvant concurrent chemoradiotherapy
RT 44 Gy/22 Fractions for 5 weeks With Chemotherapy (Cisplatin 25mg/m2 once weekly, Paclitaxel 50mg/m2 once weekly)

Drug: Cisplatin
25mg/m2 once weekly

Drug: Paclitaxel
50mg/m2 once weekly




Primary Outcome Measures :
  1. Efficacy of adjuvant pembrolizumab in N2 Positive NSCLC [ Time Frame: 24 months ]
    Disease free survival to evaluate the efficacy of adjuvant pembrolizumab in N2 positive non-small cell lung cancer patients treated with neoadjuvant concurrent chemoradiotherapy followed by curative resection.


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: From date of radomization until the date of death from any cause, withdrawal of consent, or the end of the study, assessed up to 120 months ]
    Pembrolizumab prolongs OS per RECIST 1.1.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • In order to be eligible for participation in this trial, the subject must:

    1. Be willing and able to provide written informed consent for the trial
    2. Be 18 years of age
    3. Be within 6 weeks after complete resection after neoadjuvant CCRT
    4. Have a performance status of 0 or 1 on the ECOG Performance Scale.
    5. Patients who completed neoadjuvant CCRT regimen includes 5 cycles of weekly Paclitaxel (50 mg/m2 + 5DW200 MIV over 1hr) plus Cisplatin (25 mg/m2 + N/S 150 mL MIV over 1hr) concurrent with radiotherapy (44 Gy/22fx daily fraction).
    6. Be willing to provide tissue from a obtained before neoadjuvant CCRT and surgical specimen (at least 10 slides from each surgically resected primary tumors and surgically resected metastatic lymph nodes)
    7. Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 14 days of treatment initiation.
    8. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
    9. Female subjects of childbearing potential (Section 5.7.2) must be willing to use an adequate method of contraception as outlined in Section 5.7.2 - Contraception, for the course of the study through 120 days after the last dose of study medication.

      Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

    10. Male subjects of childbearing potential (Section 5.7.1) must agree to use an adequate method of contraception as outlined in Section 5.7.1- Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.

Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

Exclusion Criteria:

  • The subject must be excluded from participating in the trial if the subject:

    1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
    2. Participation in another clinical study with PD-1 or PD-L1 inhibitors at any time
    3. Any previous treatment with a PD-1, PD-L1 inhibitor or any anti-cancer therapy after complete resection of lung cancer
    4. Current or prior use of immunosuppressive medication within 28 days before the first dose of pembrolizumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
    5. Mean QT interval corrected for heart rate (QTc) ≥470 ms using Bazett's correction
    6. Has a known history of active TB (Bacillus Tuberculosis)
    7. Active or prior documented inflammatory bowel disease (Crohn's disease or ulcerative colitis)
    8. History of allogenic organ transplant
    9. Hypersensitivity to pembrolizumab or any of its excipients.
    10. Prior history of malignancy within 2 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, or early gastric cancer. The incidentally detected, non-metastatic well differentiated thyroid cancer can be enrolled irrespective of the treatment, because the prognosis of this type of cancer is known much better than the study disease, even it is untreated. For the debatable double primary cancer, the enrolment can be discussed with the principal investigator in a manner of case by case, and if it is not expected to affect the study outcome, the subjects can be enrolled.
    11. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
    12. Has known history of, or any evidence of active, non-infectious pneumonitis.
    13. Evidence of interstitial lung disease.
    14. Has an active infection requiring systemic therapy.
    15. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
    16. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
    17. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
    18. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
    19. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
    20. Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed

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): NCT03053856


Contacts
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Contact: Myung-Ju Ahn, Professor 82-2-3410-3438 silk.ahn@samsung.com

Locations
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Korea, Republic of
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center

Additional Information:
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Responsible Party: Myung-Ju Ahn, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03053856     History of Changes
Other Study ID Numbers: 2016-09-018
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Myung-Ju Ahn, Samsung Medical Center:
stage IIIA non-small cell lung cancer
Adjuvant pembrolizumab

Additional relevant MeSH terms:
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Pembrolizumab
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological