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NCT07586202PHASE2Recruiting

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

Janssen Research & Development, LLC

Start Date

7/28/2026

Completion Date

4/3/2028

Summary

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

Age Range: 18 years to No maximum

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

Interventions

DRUG

Amivantamab

DRUG

Lazertinib

DRUG

Carboplatin

DRUG

Pemetrexed

Interested in This Trial?

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Conditions

Carcinoma, Non-Small-Cell Lung

Locations

City of Hope

Duarte, California 91010

United States

City of Hope 1

Irvine, California 92618

United States

Providence Cancer Center

Portland, Oregon 97213

United States

Providence Oncology and Hematology Care Clinic Westside

Portland, Oregon 97225

United States

Princess Margaret Hospital

Toronto, Ontario M5G 2C1

Canada

Beijing Cancer Hospital of Peking University

Beijing, 100142

China

Sichuan Cancer Hospital

Cheng Du Shi, 610044

China

West China Hospital Sichuan University

Chengdu, 610041

China

Guangdong Provincial People's Hospital

Guangzhou, 510060

China

Shandong Cancer Hospital

Jinan, 250117

China

Shanghai Pulmonary Hospital

Shanghai, 200433

China

Tianjin Chest Hospital

Tianjin, 300222

China

Kyungpook National University Chilgok Hospital

Buk Gu, 41404

South Korea

Pusan National University Hospital

Busan, 49241

South Korea

Severance Hospital Yonsei University Health System

Seoul, 03722

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Korea University Guro Hospital

Seoul, 152-703

South Korea

Hosp. Gral. Univ. Dr. Balmis

Alicante, 03010

Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007

Spain

Taichung Veterans General Hospital

Taichung, 40705

Taiwan

Chi Mei Medical Center Liouying Branch

Tainan, 736

Taiwan

Taipei Medical University Hospital

Taipei, 110

Taiwan

NTU Biomedical Park Hospital

Zhubei, 302

Taiwan