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

Merus

Status and phase

Enrolling

Phase 2

Conditions

Lung Cancer - Non Small Cell Squamous

Lung Cancer - Non Small Cell Non-Squamous

Treatments

Combination Product: Petosemtamab + Pembrolizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT07353957

MCLA-158-CL04

Details and patient eligibility

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.

Enrollment

180 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.