NCT07353957
Recruiting
Phase 2
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
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Merus N.V.
- Enrollment
- 180
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Investigators
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