Studieoverzicht

Study name: CA2440001

Histology	NSCLC, all subtypes
Tumor stage	Stage III - IV
Host / recruiting site 1	LUMC	Enrollment	Recruiting
Therapy line	First line (1L) , Later line (≥2L)
Design	A Phase 1/2a, Open-label, Dose-finding Study
Intervention	BMS-986507, bispecific EGFR×HER3 IgG1 ADC Group A combination with Osimertinib Group B combination with (platinum based chemotherapy) and Pembrolizumab
Key outcome parameters	Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy
Key inclusion criteria	Group A: EGFRmt NSCLC, no prior systemic cancer therapy including tyrosine kinases inhibitors Group B: EGFRwt NSCLC. Dose expansion second or later line (including AGA other than EGFR) Dose exploration, no prior systemic cancer therapy
Key exclusion criteria	Symptomatic CNS metastases or leptomeningeal metastases history of prior malignancy active within 2 years prior to treatment assignment requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of treatment assignment. ILD, serious recurrent infections, active autoimmune diseases, history of severe heart disease, poorly controlled hypertension by 2 kinds of antihypertensive drugs
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