Stage IIIA Non-small Cell Lung Cancer Clinical Trial
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
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.
n/a
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