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New drug duo aims to shrink lung tumors in First-Line trial

NCT ID NCT07353957

Disease control Sponsor: Merus B.V. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 5 times

Summary

This phase 2 trial tests whether adding petosemtamab to the standard immunotherapy pembrolizumab can shrink tumors in adults with metastatic non-small cell lung cancer. About 180 participants will receive the combination as their first treatment. The study focuses on how many patients respond and how long the benefit lasts.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Petosemtamab and pembrolizumab
What this could lead to
If successful, this combination could offer a new first-line treatment option for people with advanced non-small cell lung cancer, potentially improving tumor shrinkage rates.
What could go wrong
This is an early-phase trial with only 180 participants, so results may not apply to everyone. The combination may cause side effects or not work better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Started

Mar 2026

Expected to finish

Feb 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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% Exclusion 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.

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Conditions

The condition(s) this trial relates to.

lung neoplasm non-small cell lung carcinoma non-small cell squamous lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lung cancer - non small cell non-squamous Lung cancer - non small cell squamous

Contacts and locations

Locations

  • Australia Site 1

    Frankston, Victoria, 3199, Australia

  • CHU Brest Hopital la Cavale Blanche

    Brest, 29609, France

  • Centre Hospitalier Intercommunal de Creteil (CHIC)

    Créteil, 94000, France

  • Chungbuk National University Hospital

    Cheongju-si, 28645, South Korea

  • Clinica Universidad de Navarra - Pamplona

    Pamplona, 31008, Spain

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • Florida Cancer Specialists - North

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

  • HC Hospitales SL

    Marbella, 29660, Spain

  • Hopital Nord Laennec

    Nantes, 44093, France

  • Hospital Alvaro Cunqueiro

    Vigo, 36312, Spain

  • Hospital Quironsalud Malaga

    Málaga, 29004, Spain

  • Hospital Universitario de Navarra

    Pamplona, 31008, Spain

  • ICM - Montpellier Cancer Institute

    Montpellier, 34298, France

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404, South Korea

  • Leiden University Medical Center

    Leiden, 2333, Netherlands

  • Memorial Sloan Kettering Cancer Center

    Long Island City, New York, 11101, United States

  • START - Rioja

    Logroño, 26006, Spain

  • Severance Hospital - Yonsei University Health System

    Seoul, 3722, South Korea

  • Tennessee Site 1

    Nashville, Tennessee, 37209, United States

  • Tennessee Site 2

    Chattanooga, Tennessee, 37403, United States

  • The Catholic University of Korea, St. Vincents Hospital

    Suwon, 16247, South Korea

  • Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134, Italy

  • Virginia Site 1

    Fairfax, Virginia, 22031, United States

  • Virginia Site 2

    Blacksburg, Virginia, 24060, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.