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)

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 739

Inclusion Criteria

1) Registration - step 1 (ORTA step 1) ? Before patient registration, written informed consent for tumor testing must be given according to ICH/GCP and national/local regulations. For patients that accept to participate in the translational research, we recommend the informed consent for translational research be signed before registration step 1;, ? No chronic use of immunosuppressive agents and/or systemic corticosteroids or any use in the last 3 days prior to the first infusion of trial treatment:, ? Confirmed UICC v7 stage IB with T = 4 cm, II-IIIA NSCLC after complete surgical resection (lobectomy, sleeve lobectomy, bi-lobectomy or pneumonectomy) as documented in the pathology report; (Note: TNM stage according to the 7th edition of the TNM classification for lung cancer), ? Availability of tumor sample obtained at surgical resection for PD-L1 Immunohistochemistry (IHC) expression assessment. Patients must submit the tumor sample during screening for PDL1 IHC expression testing at a central pathology laboratory. Patients will be eligible to participate regardless of the level of PD-L1 status, however tissue must be considered satisfactory for characterization of PD-L1 status. Patients whose samples are inadequate for PD-L1 determination will not be randomized;, ? Resection margins proved microscopically free (R0); Resection margins are evaluated at the bronchial, venous and arterial stumps, peribronchial soft tissue, any peripheral margin near the tumor or of additionally resected tissue;, ? A systematic complete mediastinal lymph node dissection or a lobe-specific mediastinal lymph node dissection is recommended. At a minimum, the pathology and/or operative report must include the examination of at least two different mediastinal lymph node (N2) levels, one of which is the subcarinal (level 7) and the second of which is lobespecific;, ? In the uncommon clinical situation where the surgeon thoroughly examines a particular mediastinal lymph node level and does not find any lymph nodes, that mediasintal lymph node level may be counted among the minimum two required levels. However, the surgeon must clearly document in the operative report or in a separate written statement that the lymph node level was explored and no lymph nodes were present. Normal appearing lymph nodes, if present, must be biopsied or/removed; No extracapsular extension of tumor in resected mediastinal (N2) lymph nodes. Extracapsular tumor extension is permitted in resected N1 lymph nodes;, ? The highest mediastinal node removed can be positive for malignancy;, ? Carcinoma in situ can be present at bronchial margin;, ? Patients with two synchronous primary non-small cell lung cancers are excluded from the study;, ? Corticosteroid use on study for management of ECIs (pembrolizumab Event of Clinical Interest), as premedication for the administration of chemotherapies, and/or a premedication for IV contrast allergies/reactions is allowed;, ? Participants who receive adjuvant chemotherapy must begin adjuvant chemotherapy within 12 weeks of the surgery date. Patients receiving adjuvant chemotherapy must be randomized and dosed with pembrolizumab/placebo at least 3 weeks but no more than 12 weeks from the last dose of chemotherapy (Day 1 of last cycle)., ? Corticosteroid use on study for management of ECIs (pembrolizumab Event of Clinical Interest), as premedication for the administration of chemotherapies, and/or a premedication for IV contrast allergies/reactions is a

Exclusion Criteria

Not available. According to study design, all exclusion criteria are included within inclusion criteria.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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