Sharp 2015

Trial name or title	A randomized, phase 3 trial with anti‐PD‐1 monoclonal antibody pembrolizumab (MK‐3475) versus placebo for patients with early stage NSCLC after resection and completion of standard adjuvant therapy (PEARLS)
Methods	Interventional RCT, Phrase III
Participants	Number of participants: 1380 (November 2015 to August 2021) Number randomised: 1380 Experimental group (pembrolizumab immunotherapy): not specified Control group (Placebo): not specified Number evaluated: Experimental group: not specified Control group: not specified Diagnosis: participants with Stage IB or II to IIIA non‐small cell lung cancer (NSCLC) who have undergone surgical resection (lobectomy or pneumonectomy) with or without adjuvant chemotherapy will be treated with pembrolizumab or placebo. Inclusion: Pathological diagnosis of NSCLC confirmed at surgery, any histology. UICC v7 stage IB with T ≥ 4 cm, II to IIIA NSCLC at complete surgical resection with no residual disease (R0) after complete surgical resection. Tumor sample obtained at surgical resection for PD‐L1 Immunohistochemistry (IHC) expression assessment. ECOG Performance Status 0 to 1. Adequate organ function performed within 10 days of treatment initiation. Female participants must have a negative urine or serum pregnancy test at screening. The serum pregnancy test must be negative for the participant to be eligible. Female participants of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment. Female patients who are breast feeding should discontinue nursing prior to the first dose of study medication and until 44 months after the last study treatment. Male participants should agree to use an adequate method of contraception starting with the first dose of study treatment through 120 days after the last dose of study treatment. Absence of severe comorbidities that in the opinion of the Investigator might hamper the participation to the study and/or the treatment administration.
Interventions	Experimental group: Participants receive pembrolizumab 200 mg intravenously, every 3 weeks, for one year (expected maximum 18 doses). Control group: participants receive placebo intravenously, every 3 weeks, for one year (expected maximum 18 doses).
Outcomes	Overall survival, disease‐free survival
Starting date	November 2015
Contact information	Correspondence for published protocol: 1‐888‐577‐8839
Notes	participant recruiting stage