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
Study Identifier:
MCLA-158-CL04
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
Recruiting
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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.
To assess antitumor activity of petosemtamab in combination with pembrolizumab in NSCLC
To further assess antitumor activity of petosemtamab in combination with pembrolizumab in NSCLC
To assess the safety and tolerability of petosemtamab in combination with pembrolizumab in NSCLC
To characterize the PK of petosemtamab in combination with pembrolizumab in NSCLC
To characterize the immunogenicity of petosemtamab in combination with pembrolizumab in NSCLC
To correlate biomarkers in tumor samples
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Non-Small Cell Lung Cancer
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase II
Sex
Female & Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
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%
- Adequate hematologic function as defined below: a. Platelet count ≥ 100 × 109/L (without transfusion within the past 7 days) b. ANC ≥ 1.5 × 109/L c. Hemoglobin ≥ 9 g/dL (without transfusion within the past 7 days)
- At least 1 measurable lesion as defined by RECIST 1.1 by radiologic methods and confirmed by the Investigator to meet both of the following criteria: a. Non-nodal lesion that measures ≥ 10 mm in the longest diameter or lymph node lesion that measures ≥ 15 mm in the short axis b. The lesion is suitable for repeat measurement using CT/MRI. Lesions that have had external beam radiotherapy or locoregional therapy must show radiographic evidence of subsequent growth.
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.
- Has untreated CNS metastases and/or carcinomatous meningitis a. Participants whose brain metastases have been treated may participate provided they show radiographic stability (defined as 2 brain images, both obtained after treatment to the brain metastases at least 4 weeks apart, that show no evidence of intracranial progression) b. In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have returned to baseline or resolved. Any steroids administered as part of this therapy must be completed at least 3 days prior to study medication.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START La Rioja
Logroño, La Rioja, Spain, 26006
Investigator
Maria de Miguel
Status
Recruiting
Condition(s) Treated at Site
Non-Small Cell Lung Cancer