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

NCT07353957 | Recruiting Phase 2 FDA Drug

• 1 other identifier: MCLA-158-CL04
• Study Type: interventional
• Target: 180
• Locations: 7 countries
• Sites: 24

Brief 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.

Conditions

Lung Cancer - Non Small Cell Squamous; Lung Cancer - Non Small Cell Non-Squamous

Keywords

squamous; lung cancer; non-squamous lung cancer; petosemtamab

Outcome Measures

Primary Outcomes (1)

• Objective response rate per investigator assessment

  ORR was defined as the proportion of participants who had a complete response (CR) or partial response (PR) per RECIST v1.1.

  Up to 4.5 years

Secondary Outcomes (8)

• Duration of response per Investigator assessment

  Up to 4.5 years

• Disease control rate as per investigator assessment

  Up to 4.5 years

• Clinical Benefit Rate as per investigator assessment

  Up to 4.5 years

• Progression free survival as per investigator assessment

  Up to 4.5 years

• Overall survival

  Up to 4.5 years

Study Arms (2)

First line squamous non-small cell lung cancer patients

EXPERIMENTAL

Combination Product: Petosemtamab + Pembrolizumab

First line non-squamous non-small cell lung cancer patients

EXPERIMENTAL

Combination Product: Petosemtamab + Pembrolizumab

Interventions

Petosemtamab + Pembrolizumab COMBINATION_PRODUCT

Petosemtamab + Pembrolizumab

First line non-squamous non-small cell lung cancer patients; First line squamous non-small cell lung cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent and is willing and able to comply with all study procedures and contraception requirements
• Age ≥ 18 years at the signing of ICF
• At least 1 measurable lesion as defined by RECIST 1.1
• ECOG performance status of 0 or 1
• Life expectancy ≥ 12 weeks, in the opinion of the Investigator
• Adequate hematologic function
• Creatinine clearance ≥ 60 mL/min calculated according to the Cockroft and Gault formula
• Adequate liver function
• Serum albumin ≥ 3 g/dL
• Serum magnesium and corrected calcium, Grade ≤ 1 alteration
• Participants of childbearing potential must agree to use highly effective contraception methods for the duration of study participation
• Histologically confirmed metastatic (Stage IV) sqNSCLC with PD-L1 TPS ≥ 50%
• No prior systemic treatment for metastatic disease
• Testing is required per local SOC and availability of testing to document absence of actionable genomic tumor aberrations
• Histologically confirmed metastatic (Stage IV) non-squamous NSCLC with PD-L1 TPS ≥ 50%

You may not qualify if:

• Has untreated CNS metastases and/or carcinomatous meningitis
• Participation in an interventional clinical study with any investigational drug within 4 weeks prior to the first dose of study treatment OR participation in any clinical study with petosemtamab at any time prior to the first dose of study treatment, regardless of whether petosemtamab was received
• Participants who received prior treatment with a PD-(L)1 inhibitor
• Participants who have received prior systemic chemotherapy, targeted or biological antineoplastic therapy for metastatic NSCLC
• Any systemic anticancer therapy within 4 weeks prior to the first dose of study treatment
• Major surgery or radiotherapy within 3 weeks prior to the first dose of study treatment. Participants who received prior radiotherapy to ≥ 25% of bone marrow are not eligible, regardless of when it was received.
• Persistent Grade \> 1 clinically significant toxicities related to prior antineoplastic therapies using NCI-CTCAE v5.0
• History of hypersensitivity reaction to any of the excipients of petosemtamab or pembrolizumab
• Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association criteria or serious cardiac arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia); or history of myocardial infarction within 6 months prior to the first dose of study treatment
• History of prior malignancies within the last 5 years, with the exception of excised local cancer
• Current dyspnea at rest of any origin or other diseases requiring continuous oxygen therapy, including participants with a history of ILD (eg, pneumonitis or pulmonary fibrosis) or evidence of ILD on baseline chest CT scan
• Current serious illness or medical condition, including but not limited to uncontrolled active infection and clinically significant pulmonary, metabolic, or psychiatric disorders
• Known infectious disease
• Participants who are pregnant or breastfeeding.

Sponsors & Collaborators

• Merus B.V.: lead

Study Sites (24)

Florida Cancer Specialists - North

St. Petersburg, Florida, 33701-4553, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

Long Island City, New York, 11101, United States

RECRUITING

Tennessee Site 2

Chattanooga, Tennessee, 37403, United States

RECRUITING

Tennessee Site 1

Nashville, Tennessee, 37209, United States

RECRUITING

Virginia Site 2

Blacksburg, Virginia, 24060, United States

RECRUITING

Virginia Site 1

Fairfax, Virginia, 22031, United States

RECRUITING

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

RECRUITING

Australia Site 1

Frankston, Victoria, 3199, Australia

RECRUITING

CHU Brest Hopital la Cavale Blanche

Brest, 29609, France

RECRUITING

Centre Hospitalier Intercommunal de Creteil (CHIC)

Créteil, 94000, France

RECRUITING

ICM - Montpellier Cancer Institute

Montpellier, 34298, France

RECRUITING

Hopital Nord Laennec

Nantes, 44093, France

RECRUITING

Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi

Florence, 50134, Italy

RECRUITING

Leiden University Medical Center

Leiden, 2333, Netherlands

RECRUITING

Chungbuk National University Hospital

Cheongju-si, 28645, South Korea

RECRUITING

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

RECRUITING

Severance Hospital - Yonsei University Health System

Seoul, 3722, South Korea

RECRUITING

The Catholic University of Korea, St. Vincents Hospital

Suwon, 16247, South Korea

RECRUITING

START - Rioja

Logroño, 26006, Spain

RECRUITING

HC Hospitales SL

Marbella, 29660, Spain

RECRUITING

Hospital Quironsalud Malaga

Málaga, 29004, Spain

RECRUITING

Clinica Universidad de Navarra - Pamplona

Pamplona, 31008, Spain

RECRUITING

Hospital Universitario de Navarra

Pamplona, 31008, Spain

RECRUITING

Hospital Alvaro Cunqueiro

Vigo, 36312, Spain

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jay Steinberg, MD

CONTACT

+1 609-703-8014; usenquiries@merus.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 21, 2026
• Study Start: March 27, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): February 27, 2031
• Last Updated: June 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); US (6); NL (1); KR (4); FR (4); ES (6); IT (1)