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WithdrawnPhase 2NCT07353957
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPetosemtamab + Pembrolizumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 13, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Withdrawn

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?24 U.S. locations

Locations may change over time.

Who runs it?Merus B.V.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Merus B.V.
Interventions being studied
Combination Product: Petosemtamab + Pembrolizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Treatment approach
Immunotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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%
Reasons someone may not be able to joinExclusion criteria
  • 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Florida Cancer Specialists - NorthSt. Petersburg, Florida
  • Memorial Sloan Kettering Cancer CenterLong Island City, New York
  • Tennessee Site 2Chattanooga, Tennessee
  • Tennessee Site 1Nashville, Tennessee
  • Virginia Site 2Blacksburg, Virginia
  • Virginia Site 1Fairfax, Virginia
  • Flinders Medical CentreBedford Park, South Australia
  • Australia Site 1Frankston, Victoria
  • CHU Brest Hopital la Cavale BlancheBrest
  • Centre Hospitalier Intercommunal de Creteil (CHIC)Créteil
  • ICM - Montpellier Cancer InstituteMontpellier
  • Hopital Nord LaennecNantes

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 13, 2026. Always confirm current availability with the study team.

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