Chemo +/- Pembrolizumab (MK-3475) as Perioperative Therapy for Stage II, IIIA-Resectable IIIB (N2) NSCLC
- Conditions
- eoadjuvant/Adjuvant treatment for participants with Resectable Stage II or IIIA-B (N2) NSCLCMedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-504820-24-00
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 786
Have previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) NSCLC., If male, must agree to use contraception or practice abstinence as well as refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention after the last dose of study intervention., If female, may participate if not pregnant or breastfeeding, and at least one of the following conditions apply: 1) not a woman of childbearing potential (WOCBP); or 2) a WOCBP who agrees to follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period., Have available formalin-fixed paraffin embedded (FFPE) tumor tissue sample blocks for submission. If blocks are not available, have unstained slides for submission for central programmed death-ligand 1 (PD-L1) testing., Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days of randomization., Have adequate organ function.
Has one of the following tumor locations/types:1) NSCLC involving the superior sulcus; 2) Large cell neuro-endocrine cancer (LCNEC); or 3) Sarcomatoid tumor., Has a known history of active tuberculosis., Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant’s participation for the full duration of the trial, or is not in the best interest of the participant to participate., Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial., Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor., Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy prior to randomization/allocation., Has received prior radiotherapy within 2 weeks of start of trial treatment., Has received a live vaccine within 30 days prior to the first dose of trial drug., Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment., Has a diagnosis of immunodeficiency or is receiving either systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of trial drug., Has a known additional malignancy that is progressing or requires active treatment within the past 5 years., Has a history of (non-infectious) pneumonitis /interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease that requires steroids., Has an active infection requiring systemic therapy., Has had an allogenic tissue/sold organ transplant., Has a known severe hypersensitivity (= Grade 3) to pembrolizumab, its active substance and/or any of its excipients., Has a known severe hypersensitivity (= Grade 3) to any of the study chemotherapy agents and/or to any of their excipients., Has an active autoimmune disease that has required systemic treatment in past 2 years., Has a known history of human immunodeficiency virus (HIV) infection., Has a known history of Hepatitis B or Hepatitis C.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. To evaluate event-free survival (EFS) by biopsy assessed by a local pathologist or by investigator-assessed imaging using RECIST 1.1.<br>2. To evaluate the overall survival (OS).;Secondary Objective: To evaluate the rate of major pathological response (mPR) assessed by blinded central laboratory pathologist following NAC +/- pembrolizumab., To evaluate the rate of pathological complete response (pCR) in the resected primary tumor and lymph nodes assessed by blinded central laboratory pathologist following NAC +/- pembrolizumab., To evaluate mean change from baseline in the neoadjuvant phase and in the adjuvant phase in global health status/quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) QoL questionnaire (QLQ)-C30., To evaluate the safety and tolerability of NAC plus pembrolizumab followed by surgery and adjuvant pembrolizumab.;Primary end point(s): Event Free Survival (EFS), Overall Survival (OS)
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Major Pathological Response (mPR) Rate;Secondary end point(s):Pathological Complete Response (pCR) Rate;Secondary end point(s):Global Health Status/Quality of Life (GHS/QoL) Score using the European Organization for Research and Treatment (EORTC) QoL Questionnaire (QLQ-C30);Secondary end point(s):Adverse Events (AEs);Secondary end point(s):Perioperative Complications;Secondary end point(s):Treatment Discontinuations Due to AEs