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

Phase 2RecruitingNCT07586202

Janssen Research & Development, LLC68 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

AmivantamabDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

City of Hope

Duarte, California, United States

RECRUITING

City of Hope 1

Irvine, California, United States

RECRUITING

Providence Cancer Center

Portland, Oregon, United States

RECRUITING

Providence Oncology and Hematology Care Clinic Westside

Portland, Oregon, United States

RECRUITING

Princess Margaret Hospital

Toronto, Ontario, Canada

RECRUITING

Sichuan Cancer Hospital

Cheng Du Shi, China

RECRUITING

West China Hospital Sichuan University

Chengdu, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, China

RECRUITING

Shandong Cancer Hospital

Jinan, China

RECRUITING

Tianjin Chest Hospital

Tianjin, China

RECRUITING

...and 10 more locations

Outcomes

Primary Outcomes

Major Pathologic response (MPR)

MPR is defined as less than or equal to (\<= ) 10 percent (%) residual cancer cells in the surgical specimen, per independent centralized pathology review.