Actively Recruiting
Study to Investigate Petosemtamab in Adults With Metastatic Non-Small Cell Lung Cancer
Led by Merus B.V. · Updated on 2026-04-02
180
Participants Needed
5
Research Sites
309 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study to Investigate Petosemtamab in Adults With Metastatic Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent and willing to follow all study procedures and contraception requirements
- Age 18 years or older at the time of consent
- At least one measurable tumor lesion based on RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Life expectancy of 12 weeks or more as judged by the investigator
- Adequate blood and organ function including hematologic function, creatinine clearance of at least 60 mL/min, liver function, serum albumin of at least 3 g/dL, and serum magnesium and corrected calcium with Grade 1 or less alteration
- Participants with childbearing potential must agree to use highly effective contraception during the study
- Histologically confirmed metastatic (Stage IV) squamous non-small cell lung cancer with PD-L1 TPS of 50% or higher
- No prior systemic treatment for metastatic disease
- Testing done per local standard of care to confirm absence of actionable genomic tumor changes
- Histologically confirmed metastatic (Stage IV) non-squamous non-small cell lung cancer with PD-L1 TPS of 50% or higher
You will not qualify if you...
- Untreated central nervous system metastases or carcinomatous meningitis
- Participation in any investigational drug study within 4 weeks before starting this study or any prior study involving petosemtamab
- Prior treatment with PD-(L)1 inhibitors
- Previous systemic chemotherapy, targeted therapy, or biological therapy for metastatic non-small cell lung cancer
- Any systemic anticancer therapy within 4 weeks before starting study treatment
- Major surgery or radiotherapy within 3 weeks before starting study treatment; prior radiotherapy to 25% or more of bone marrow at any time
- Persistent Grade greater than 1 toxicities related to prior cancer therapies
- History of allergic reactions to petosemtamab, pembrolizumab, or their components
- Unstable angina, serious heart failure (Class II-IV), serious cardiac arrhythmias needing treatment, or recent heart attack within 6 months
- History of other cancers within the last 5 years except for completely removed local cancers
- Current resting breathlessness or diseases requiring continuous oxygen therapy, including interstitial lung diseases
- Serious uncontrolled illnesses including infections, pulmonary, metabolic, or psychiatric disorders
- Known infectious diseases
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Tennessee Site 2
Chattanooga, Tennessee, United States, 37403
Actively Recruiting
2
Tennessee Site 1
Nashville, Tennessee, United States, 37209
Actively Recruiting
3
Virginia Site 2
Blacksburg, Virginia, United States, 24060
Actively Recruiting
4
Virginia Site 1
Fairfax, Virginia, United States, 22031
Actively Recruiting
5
Australia Site 1
Frankston, Victoria, Australia, 3199
Actively Recruiting
Research Team
J
Jay Steinberg, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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