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
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|
|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)|
|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|
Experimental: Pembrolizumab arm
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)
25mg/m2 once weekly
50mg/m2 once weekly
- 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.
- 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.
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
|Contact: Myung-Ju Ahn, Professorfirstname.lastname@example.org|
|Korea, Republic of|
|Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine|
|Seoul, Korea, Republic of, 135-710|