A randomized trial of adjuvant Pembrolizumab following surgical resection versus observation following surgical resection in patients with stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm.
Patients will be randomized (1:1) 4-12 weeks following surgery to either:
* Arm A: Pembrolizumab 400 mg every 6 weeks × 9 cycles * Arm B: Observation
Stratification factors will include: PD-L1 TPS (\<50% vs. ≥50%), and tumor size (1-2 cm vs. \>2-4 cm)
The participant (or legally acceptable representative if applicable) must provide written informed consent for the study. The participant may also provide consent for future unspecified research samples. However, the participant may participate in the study without participating in the future unspecified research sample collection. NOTE: Initial informed consent will remain valid throughout the 12-week period between surgical resection and study registration unless, in the opinion of the treating investigator, the participant experiences a significant change in medical or mental status.
Males and females age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-1 within 28 days prior to registration.
Patients must have undergone complete surgical resection of their stage I NSCLC between 4-12 weeks prior to registration and have negative surgical margins (R0).
Current lung cancer is <1 cm or > 4 cm in size or is stage II, III, or IV.
Patients with tumors that are known to harbor actionable EGFR mutations.
Prior chemotherapy, radiation therapy, or immunotherapy for the treatment of this lung cancer.
Has a known active additional malignancy that is progressing or has required active treatment within the past 2 years. NOTE: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma in situ, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA <10 ng/mL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.
Parallel
Pembrolizumab
DrugPembrolizumab 400mg IV
Disease Free Survival (DFS)
To evaluate whether the addition of adjuvant Pembrolizumab following surgical resection improves disease free survival compared with observation following surgical resection in patients with stage I non-small cell lung cancer (NSCLC) that is between 1-4 cm in size, regardless of PD-L1 TPS score. Median Disease Free Survival (DFS) will be reported.
Overall Survival (OS)
To evaluate whether the addition of adjuvant Pembrolizumab following surgical resection improves overall survival compared with observation in patients with stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm in size, regardless of PD-L1 TPS. Median Overall Survival will be reported
1 Year Disease Free Survival Rate
To evaluate the disease-free survival rate at 1 year on each arm.
1 Year Overall Survival Rate
To evaluate the overall survival rate at 1 year on each arm.
2 Year Disease Free Survival Rate
To evaluate the disease-free survival rate at 2 years on each arm.
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Greg Durm, MD
Lead sponsor
Big Ten Cancer Research Consortium
Sponsor institution
Merck Sharp & Dohme LLC
Collaborator
