Study start date
Histologically documented unresectable locally advanced/metastatic non-squamous NSCLCPart 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting. Part 2: Treatment-naïve for non curative treatment for locally advanced or metastatic NSCLC. Part 2: Patients must have tumors that lack activating EGFR mutations, EML4-ALK fusion or other targetable alterations. Prior adjuvant, neoadjuvant therapies are permitted if progression has occurred > 12 months from the end of last therapy HER2+ (IHC 3+ or IHC 2+) status as determined by central review of tumor tissue WHO / ECOG performance status of 0 or 1 Measurable target disease assessed by the investigator using RECIST 1.1 Has protocol defined adequate organ and bone marrow function
HER2 mutation if previously knownHas a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder and prior pneumonectomy Active primary immunodeficiency known HIV infection, or active hepatitis B or C infection Active infection including tuberculosis and uncontrolled infection requiring IV antibiotics, antivirals, or antifungals Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms Medical history of myocardial infarction within 6 months before treatment assignment, symptomatic CHF (New York Heart Association Class II to IV), clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or CART (Concentrated Ascites Reinfusion Therapy) Unresolved toxicities from previous anticancer therapy OR prior discontinuation of any planned study therapy due to toxicity.