NCT03053856

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stage IIIA Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Adjuvant pembrolizumab 200 mg every 3 weeks for up to 24 months. (treated with neoadjuvant concurrent chemoradiotherapy followed by curative resection)
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

Timeline

• Start date: 2017-02-14
• Primary completion: 2021-05-13
• Completion: 2021-08-13
• First posted: 2017-02-15
• Last updated: 2017-02-15

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study