OncoMatch/Clinical Trials/NCT04317534
Adjuvant Pembrolizumab vs Observation Following Curative Resection for Stage I Non-small Cell Lung Cancer (NSCLC) With Primary Tumors Between 1-4 cm
Is NCT04317534 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pembrolizumab for nsclc, stage i.
Treatment: Pembrolizumab — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)
Excluded: EGFR actionable mutation
Disease stage
Required: Stage I
Excluded: Stage II, III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: surgery — curative resection
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).
Cannot have received: chemotherapy
Prior chemotherapy ... for the treatment of this lung cancer.
Cannot have received: radiation therapy
Prior ... radiation therapy ... for the treatment of this lung cancer.
Cannot have received: immunotherapy
Prior ... immunotherapy for the treatment of this lung cancer.
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
Lab requirements
Blood counts
Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 28 days prior to registration.
Kidney function
Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 28 days prior to registration.
Liver function
Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 28 days prior to registration.
Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 28 days prior to registration.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffit Cancer Center · Tampa, Florida
- University of Illinois Cancer Center · Chicago, Illinois
- Indiana University Melvin and Bren Simon Cancer Center · Indianapolis, Indiana
- University of Iowa Hospitals and Clinics · Iowa City, Iowa
- University of Minnesota · Minneapolis, Minnesota
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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