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Clinical Trials in the USA / NCT04165070
Recruiting Phase 1/2

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)

NCT04165070 · tracked via the Priya Life Science USA tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 1/2
Started
2019-12-19
Last updated
2026-08-25

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

PembrolizumabCarboplatinPaclitaxelPemetrexedVibostolimabBoserolimabMK-4830MK-0482Ifinatamab Deruxtecan (I-DXd)HER3-DXd

Pembrolizumab: IV infusion

Carboplatin: IV infusion

Paclitaxel: IV infusion

Pemetrexed: IV infusion

Vibostolimab: IV infusion

Boserolimab: IV infusion

MK-4830: IV infusion

MK-0482: IV Infusion

Ifinatamab Deruxtecan (I-DXd): IV infusion

HER3-DXd: IV Infusion

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (46)

FacilityCityRegionStatus
Banner MD Anderson Cancer Center ( Site 0001) Gilbert Arizona Completed
City of Hope ( Site 0014) Duarte California Completed
UCSF Medical Center at Mission Bay ( Site 0007) San Francisco California Completed
Georgetown University ( Site 0036) Washington D.C. District of Columbia Completed
University of Kentucky Markey Cancer Center ( Site 0019) Lexington Kentucky Completed
MedStar Franklin Square Medical Center ( Site 0033) Baltimore Maryland Completed
Massachusetts General Hospital ( Site 0003) Boston Massachusetts Completed
Dana Farber Cancer Institute ( Site 0002) Boston Massachusetts Completed
Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031) Omaha Nebraska Completed
Dartmouth Hitchcock Medical Center ( Site 0016) Lebanon New Hampshire Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037) Hackensack New Jersey Completed
Laura and Isaac Perlmutter Cancer Center ( Site 0034) New York New York Completed
Sanford Fargo Medical Center ( Site 0039) Fargo North Dakota Recruiting
Cleveland Clinic Main ( Site 0006) Cleveland Ohio Completed
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0015) Columbus Ohio Recruiting
Abramson Cancer Center of the University of Pennsylvania ( Site 0010) Philadelphia Pennsylvania Recruiting
Sanford Cancer Center ( Site 0038) Sioux Falls South Dakota Recruiting
The University of Texas MD Anderson Cancer Center ( Site 0009) Houston Texas Recruiting
Petz Aladar Megyei Oktato Korhaz ( Site 0062) Győr Győr-Moson-Sopron Completed
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061) Szolnok Jász-Nagykun-Szolnok Completed
Orszagos Koranyi Pulmonologiai Intezet ( Site 0060) Budapest Hungary Completed
Soroka Medical Center ( Site 0072) Beersheba Israel Completed
Rambam Health Care Campus-Oncology ( Site 0076) Haifa Israel Completed
Shaare Zedek Medical Center ( Site 0075) Jerusalem Israel Recruiting
Meir Medical Center ( Site 0071) Kfar Saba Israel Completed
Rabin Medical Center ( Site 0074) Petah Tikva Israel Completed
Chaim Sheba Medical Center ( Site 0070) Ramat Gan Israel Recruiting
Sourasky Medical Center ( Site 0077) Tel Aviv Israel Completed
Azienda Ospedaliera Universitaria Careggi ( Site 0173) Florence Firenze Completed
IRCCS Ospedale San Raffaele ( Site 0171) Milan Italy Completed
Policlinico Gemelli di Roma ( Site 0174) Roma Italy Completed
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151) Warsaw Masovian Voivodeship Completed
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150) Gdansk Pomeranian Voivodeship Completed
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152) Koszalin West Pomeranian Voivodeship Active Not Recruiting
Seoul National University Bundang Hospital ( Site 0081) Seongnam-si Kyonggi-do Completed
Severance Hospital ( Site 0080) Seoul South Korea Completed
Samsung Medical Center ( Site 0082) Seoul South Korea Completed
ICO L Hospitalet ( Site 0090) L'Hospitalet de Llobregat Barcelona Completed
Hospital Universitario Quiron Madrid ( Site 0091) Madrid Spain Completed
Changhua Christian Hospital ( Site 0181) Changhua Taiwan Recruiting

+ 6 more sites — see the full list on the official registry below.

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04165070 on ClinicalTrials.gov ↗ ← All trials in the USA