RecruitingPhase 2NCT07353957

Study to Investigate Petosemtamab in Adults With Metastatic Non-Small Cell Lung Cancer

A Phase 2 Study to Investigate the Safety and Efficacy of Petosemtamab in Adults With Metastatic Non-Small Cell Lung Cancer in Combination With Pembrolizumab as First-Line Treatment


Sponsor

Merus B.V.

Enrollment

180 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study will test the efficacy and safety of petosemtamab in combination with Pembrolizumab in first line patients with squamous non-small cell lung cancer and non-squamous non-small cell lung cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing petosemtamab, a new type of targeted drug, combined with pembrolizumab (an established immunotherapy) as a first-line treatment for people with advanced, metastatic non-small cell lung cancer (NSCLC) that has not yet been treated. The study focuses on people whose tumors have high PD-L1 expression, which may make them more responsive to immunotherapy. **You may be eligible if:** - You are 18 or older with a confirmed diagnosis of metastatic (stage IV) non-small cell lung cancer - Your tumor has high PD-L1 expression (TPS ≥ 50%) - You have at least one measurable tumor on imaging scans - You have not received any prior treatment for your metastatic cancer - Your general health is good (ECOG performance status 0 or 1) - Your blood counts, kidney, and liver function are adequate **You may NOT be eligible if:** - You have untreated brain metastases or cancer spreading to the lining of the brain - You have previously received immunotherapy (PD-1/PD-L1 inhibitors) or chemotherapy for metastatic disease - You have had recent major surgery or radiation therapy - You have uncontrolled heart failure, recent heart attack, or serious heart arrhythmia - You have a lung condition such as pulmonary fibrosis or interstitial lung disease - You have an active serious infection or known infectious disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTPetosemtamab + Pembrolizumab

Petosemtamab + Pembrolizumab


Locations(24)

Florida Cancer Specialists - North

St. Petersburg, Florida, United States

Memorial Sloan Kettering Cancer Center

Long Island City, New York, United States

Tennessee Site 2

Chattanooga, Tennessee, United States

Tennessee Site 1

Nashville, Tennessee, United States

Virginia Site 2

Blacksburg, Virginia, United States

Virginia Site 1

Fairfax, Virginia, United States

Flinders Medical Centre

Bedford Park, South Australia, Australia

Australia Site 1

Frankston, Victoria, Australia

CHU Brest Hopital la Cavale Blanche

Brest, France

Centre Hospitalier Intercommunal de Creteil (CHIC)

Créteil, France

ICM - Montpellier Cancer Institute

Montpellier, France

Hopital Nord Laennec

Nantes, France

Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Leiden University Medical Center

Leiden, Netherlands

Chungbuk National University Hospital

Cheongju-si, South Korea

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Severance Hospital - Yonsei University Health System

Seoul, South Korea

The Catholic University of Korea, St. Vincents Hospital

Suwon, South Korea

START - Rioja

Logroño, Spain

HC Hospitales SL

Marbella, Spain

Hospital Quironsalud Malaga

Málaga, Spain

Clinica Universidad de Navarra - Pamplona

Pamplona, Spain

Hospital Universitario de Navarra

Pamplona, Spain

Hospital Alvaro Cunqueiro

Vigo, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07353957