A Phase 2 Study of Petosemtamab in Combination with Pembrolizumab in Adults with NSCLC

Prior treatment

• 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.
• 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

Other

• Please refer to the protocol for further criteria

• Able to provide written informed consent and is willing and able to comply with all study procedures and contraception requirements (see Appendix 4)
• 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)
• Creatinine clearance ≥ 60 mL/min calculated according to the Cockroft and Gault formula
• Age ≥ 18 years at the signing of ICF
• 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.
• ECOG performance status of 0 or 1
• Life expectancy ≥ 12 weeks, in the opinion of the Investigator
• Please refer to the protocol for further criteria