A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC

Purpose

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.

Condition

  • Carcinoma, Non-Small-Cell Lung

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 - Have an eastern cooperative oncology group (ECOG) performance status of 0 or 1

Exclusion Criteria

  • 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 - Prior treatment with any systemic anti-cancer therapy for NSCLC including EGFR-tyrosine kinase inhibitor (TKI) therapy, chemotherapy, biologic therapy, immunotherapy, or any investigational drug

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1: Amivantamab plus Lazertinib 		Participants will receive amivantamab in combination with lazertinib.
  • Drug: Amivantamab
    Amivantamab will be administered.
    Other names:
    • JNJ-61186372
  • Drug: Lazertinib
    Lazertinib will be administered.
    Other names:
    • JNJ-73841937
Experimental
Cohort 2: Amivantamab plus Carboplatin and Pemetrexed 		Participants will receive amivantamab in combination with carboplatin and pemetrexed.
  • Drug: Amivantamab
    Amivantamab will be administered.
    Other names:
    • JNJ-61186372
  • Drug: Carboplatin
    Carboplatin will be administered.
  • Drug: Pemetrexed
    Pemetrexed will be administered.

Recruiting Locations

City of Hope
Duarte, California 91010

City of Hope 1
Irvine, California 92618

Providence Cancer Center
Portland, Oregon 97213

Providence Oncology and Hematology Care Clinic Westside
Portland, Oregon 97225

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com