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Randomized Phase II Trial of Adjuvant Pembrolizumab Versus Observation Following Curative Resection for Stage I Non-Small Cell Lung Cancer (NSCLC) with Primary Tumors between 1-4 cm

Objective

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 nonsmall cell lung cancer (NSCLC) with primary tumors between 1-4 cm in size, regardless of PD-L1 TPS score.

Protocol #

BTCRC-LUN18-153

Trial Phase:

Phase II

Principal Investigator:

Shah, Rachit

Cancer Type
  • Lung
Study Site
  • Stony Point
  • Tappahannock
  • Tappahannock - VCU Study Site
  • Virginia Commonwealth University

Males and females age >/= 18 years at the time of consent
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).
NOTE: Both squamous and non-squamous histologies are allowed into the study.
Cancers with a histology of “adenosquamous” are considered a type of adenocarcinoma and thus “non-squamous histology”.
NOTE: Staging will be according to the AJCC 8th edition. Pathological tumor size must be 1.0 – 4.0 cm in greatest dimension

Get more detailed information at ClinicalTrials.gov

  • Enrollment Status 1
  • Age Group Adult
  • Protocol Type Treatment
  • Research Study Team Carrie Donovan, RN
    Phone: +1 804-628-3836
    Email Study Contact

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