About this trial
The purpose of this study is to assess the ability to slow down or stop the growth of cancer with amivantamab combined with either lazertinib or chemotherapy (carboplatin and pemetrexed) in participants with resectable, epidermal growth factor receptor (EGFR) mutated, Stage II-IIIB non-small cell lung cancer (NSCLC). NSCLC is the most common type of lung cancer. NSCLC may occur due to mutations (changes) in many genes, including EGFR.
Eligibility criteria
Qualifiers
Participant must have histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) with completely resectable Stage II-IIIB N2 disease
Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a multidisciplinary team evaluation
Participant must consent to a screening biopsy, if clinically feasible, if no adequate tumor tissue is available for a baseline sample
Participant may have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s). Prior or concurrent second malignancies must be reviewed and agreed to with the medical monitor
Disqualifiers
History of uncontrolled illness
Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current interstitial lung disease (ILD)/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
Suspected or known allergies, hypersensitivity, or intolerance to excipients of: the combination of amivantamab and lazertinib or carboplatin and pemetrexed
Presence of primary driver mutations (anaplastic lymphoma kinase [ALK], mesenchymal-epithelial transition [MET], human epidermal growth factor receptor 2 [HER2], proto-oncogene tyrosine-protein kinase ROS [ROS1], neurotrophic tyrosine receptor kinase [NTRK], B-Raf proto-oncogene [BRAF], REarranged during transfection [RET], or kirsten rat sarcoma viral oncogene homolog [KRAS]) , besides EGFR Exon 19del or Exon 21 L858R mutations, as determined by local genomic testing
Trial design
Treatments tested in this trial
- Amivantamab
- Lazertinib
- Carboplatin
- Pemetrexed