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Clinical Trials in China / NCT07586202
Recruiting Phase 2

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

NCT07586202 · tracked via the Priya Life Science China tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 2
Started
2026-07-28
Last updated
2026-08-28

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

Amivantamab →Lazertinib →Carboplatin →Pemetrexed →

Amivantamab: Amivantamab will be administered.

Lazertinib: Lazertinib will be administered.

Carboplatin: Carboplatin will be administered.

Pemetrexed: Pemetrexed will be administered.

Study 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

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
City of Hope Duarte California Recruiting
City of Hope 1 Irvine California Recruiting
Providence Cancer Center Portland Oregon Recruiting
Providence Oncology and Hematology Care Clinic Westside Portland Oregon Recruiting
Princess Margaret Hospital Toronto Ontario 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
Kyungpook National University Chilgok Hospital Buk Gu South Korea Recruiting
Pusan National University Hospital Busan South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Korea University Guro Hospital Seoul South Korea Recruiting
Hosp. Gral. Univ. Dr. Balmis Alicante Spain Recruiting
Hosp. Gral. Univ. Gregorio Maranon Madrid Spain Recruiting
Taichung Veterans General Hospital Taichung Taiwan Recruiting
Chi Mei Medical Center Liouying Branch Tainan Taiwan Recruiting
Taipei Medical University Hospital Taipei Taiwan Recruiting
NTU Biomedical Park Hospital Zhubei Taiwan Recruiting

More Janssen Research & Development, LLC trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07586202 on ClinicalTrials.gov ↗ ← All trials in China