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NCT04165070PHASE1, PHASE2Recruiting

KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)

Merck Sharp & Dohme LLC

Start Date

12/19/2019

Completion Date

10/13/2032

Summary

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in treatment-naïve participants with advanced squamous or non-squamous NSCLC. This study is one of the pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).

Detailed Description

The master screening protocol is MK-3475-U01 (KEYMAKER-U01) - NCT04165798

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC * Participants with nonsquamous NSCLC who are not eligible for an approved targeted therapy * Is able to provide archival tumor tissue sample collected either within 5 years or within the interval from completion of last treatment but before entering the screening period or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated obtained within 90 days of treatment initiation * Has not received prior systemic treatment for their metastatic NSCLC * Is able to complete all screening procedures within the 35-day screening window for Part A and 28-day screening window for Part B Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a diagnosis of small cell lung cancer * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment * Has a known additional malignancy that is progressing or has required active treatment within the past 2 years * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has an active autoimmune disease that has required systemic treatment in the past 2 years * Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis * Has an active infection requiring systemic therapy * Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study treatment administration, or New York Heart Association Class III or IV congestive heart failure * Has a known history of human immunodeficiency virus (HIV) infection. Well-controlled HIV with anti-retroviral therapy (ART) is not excluded * Has a known history of Hepatitis B (HPV) or known active Hepatitis C virus infection. Hepatitis B surface antigen (HBsAg) positive is eligible if on HBV antiviral therapy for at least 4 weeks and HBV viral load is undetectable prior to randomization * Has had major surgery \<3 weeks before the first dose of study treatment * Is expected to require any other form of antineoplastic therapy while on study * Has a history or current evidence of a gastrointestinal (GI) condition (e.g. inflammatory bowel disease, Crohn's disease, ulcerative colitis) or impaired liver function or diseases that in the opinion of the investigator may significantly alter the absorption or metabolism of oral medications * Is getting chemotherapy and has clinically active diverticulitis, intra-abdominal abscess, GI obstruction, or peritoneal carcinomatosis * Has preexisting neuropathy that is moderate in intensity * Has received prior systemic cytotoxic chemotherapy or other targeted or biological antineoplastic therapy for metastatic disease * Is unable or unwilling to take folic acid or vitamin B12 supplementation, for participants who will receive pemetrexed * Has a known sensitivity to any component of carboplatin, paclitaxel, pemetrexed or any of their excipients * Has received prior radiation therapy to the lung that is \>30 Gray (Gy) within 6 months of the first dose of study treatment * Has received a live vaccine within 30 days before the first dose of study treatment. Any licensed COVID-19 vaccine (including for Emergency Use) in a particular country is allowed as long as they are messenger ribonucleic acid (mRNA) vaccines, adenoviral vaccines, or inactivated vaccines. Investigational vaccines (ie, those not licensed or approved for Emergency Use) are not allowed * Has received any prior immunotherapy and was discontinued from that treatment due to a severe or worse immune-related adverse event (irAE) * Has had chemotherapy or biological cancer therapy within 4 weeks before the first dose of study treatment or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the AEs due to cancer therapeutics administered more than 4 weeks before the first dose of study treatment (including participants who had previous immunomodulatory therapy with residual irAEs) * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study treatment * Previously had a severe hypersensitivity reaction to treatment with monoclonal antibodies (including pembrolizumab) and/or any of their excipients * Has had an allogenic tissue/solid organ transplant

Interventions

BIOLOGICAL

Pembrolizumab

DRUG

Carboplatin

DRUG

Paclitaxel

DRUG

Pemetrexed

BIOLOGICAL

Vibostolimab

BIOLOGICAL

Boserolimab

BIOLOGICAL

MK-4830

BIOLOGICAL

MK-0482

BIOLOGICAL

Ifinatamab Deruxtecan (I-DXd)

BIOLOGICAL

HER3-DXd

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Conditions

Carcinoma, Non-Small-Cell Lung

Locations

Banner MD Anderson Cancer Center ( Site 0001)

Gilbert, Arizona 85234

United States

City of Hope ( Site 0014)

Duarte, California 91010

United States

UCSF Medical Center at Mission Bay ( Site 0007)

San Francisco, California 94158

United States

Georgetown University ( Site 0036)

Washington D.C., District of Columbia 20007

United States

University of Kentucky Markey Cancer Center ( Site 0019)

Lexington, Kentucky 40536-0293

United States

MedStar Franklin Square Medical Center ( Site 0033)

Baltimore, Maryland 21237

United States

Massachusetts General Hospital ( Site 0003)

Boston, Massachusetts 02114

United States

Dana Farber Cancer Institute ( Site 0002)

Boston, Massachusetts 02215

United States

Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)

Omaha, Nebraska 68130

United States

Dartmouth Hitchcock Medical Center ( Site 0016)

Lebanon, New Hampshire 03766

United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)

Hackensack, New Jersey 07601

United States

Laura and Isaac Perlmutter Cancer Center ( Site 0034)

New York, New York 10016

United States

Sanford Fargo Medical Center ( Site 0039)

Fargo, North Dakota 58102

United States

Cleveland Clinic Main ( Site 0006)

Cleveland, Ohio 44195

United States

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0015)

Columbus, Ohio 43210

United States

Abramson Cancer Center of the University of Pennsylvania ( Site 0010)

Philadelphia, Pennsylvania 19104

United States

Sanford Cancer Center ( Site 0038)

Sioux Falls, South Dakota 57104

United States

The University of Texas MD Anderson Cancer Center ( Site 0009)

Houston, Texas 77030

United States

Petz Aladar Megyei Oktato Korhaz ( Site 0062)

Győr, Győr-Moson-Sopron 9024

Hungary

Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061)

Szolnok, Jász-Nagykun-Szolnok 5004

Hungary

Orszagos Koranyi Pulmonologiai Intezet ( Site 0060)

Budapest, 1121

Hungary

Soroka Medical Center ( Site 0072)

Beersheba, 8457108

Israel

Rambam Health Care Campus-Oncology ( Site 0076)

Haifa, 3109601

Israel

Shaare Zedek Medical Center ( Site 0075)

Jerusalem, 9103102

Israel

Meir Medical Center ( Site 0071)

Kfar Saba, 4428132

Israel

Rabin Medical Center ( Site 0074)

Petah Tikva, 4941492

Israel

Chaim Sheba Medical Center ( Site 0070)

Ramat Gan, 5262000

Israel

Sourasky Medical Center ( Site 0077)

Tel Aviv, 6423906

Israel

Azienda Ospedaliera Universitaria Careggi ( Site 0173)

Florence, Firenze 50134

Italy

IRCCS Ospedale San Raffaele ( Site 0171)

Milan, 20132

Italy

Policlinico Gemelli di Roma ( Site 0174)

Roma, 00168

Italy

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)

Warsaw, Masovian Voivodeship 02-781

Poland

Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)

Gdansk, Pomeranian Voivodeship 80-952

Poland

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152)

Koszalin, West Pomeranian Voivodeship 75-581

Poland

Seoul National University Bundang Hospital ( Site 0081)

Seongnam-si, Kyonggi-do 13620

South Korea

Severance Hospital ( Site 0080)

Seoul, 03722

South Korea

Samsung Medical Center ( Site 0082)

Seoul, 06351

South Korea

ICO L Hospitalet ( Site 0090)

L'Hospitalet de Llobregat, Barcelona 08907

Spain

Hospital Universitario Quiron Madrid ( Site 0091)

Madrid, 28223

Spain

Changhua Christian Hospital ( Site 0181)

Changhua, 50006

Taiwan

Taipei Medical University Hospital ( Site 0180)

Taipei, 110301

Taiwan

Chang Gung Medical Foundation-Linkou Branch ( Site 0182)

Taoyuan, 33305

Taiwan

COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0463)

Cherkasy, Cherkasy Oblast 18009

Ukraine

Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Surgery department #2 ( Site 0460)

Ivano-Frankivsk, Ivano-Frankivsk Oblast 76018

Ukraine

ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461)

Rivne, Rivne Oblast 33010

Ukraine

Uzhhorod Multispecialty City Clinical Hospital ( Site 0462)

Uzhhorod, Zakarpattia Oblast 88017

Ukraine