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

NCT07586202 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 61186372PANSC2005
• Study Type: interventional
• Target: 68
• Locations: 6 countries
• Sites: 23

Brief 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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 year 8 months

Secondary Outcomes (5)

• Pathological Complete Response (pCR)

  Up to 1 year 8 months

• Number of Participants with Pathologic Nodal Downstaging at the Time of Surgery

  Baseline and up to 1 year 8 months

• Disease Control Rate (DCR)

  Up to 1 year 8 months

• Number of Participants with Adverse Events (AEs) by Severity

  Up to 1 year 8 months

• Number of Participants with Abnormalities in Clinical Laboratory Parameters

  Up to 1 year 8 months

Study Arms (2)

Cohort 1: Amivantamab plus Lazertinib

EXPERIMENTAL

Participants will receive amivantamab in combination with lazertinib.

Drug: Amivantamab; Drug: Lazertinib

Cohort 2: Amivantamab plus Carboplatin and Pemetrexed

EXPERIMENTAL

Participants will receive amivantamab in combination with carboplatin and pemetrexed.

Drug: Amivantamab; Drug: Carboplatin; Drug: Pemetrexed

Interventions

Amivantamab DRUG

Amivantamab will be administered.

Also known as: JNJ-61186372

Cohort 1: Amivantamab plus Lazertinib; Cohort 2: Amivantamab plus Carboplatin and Pemetrexed

Lazertinib DRUG

Lazertinib will be administered.

Also known as: JNJ-73841937

Cohort 1: Amivantamab plus Lazertinib

Carboplatin DRUG

Carboplatin will be administered.

Cohort 2: Amivantamab plus Carboplatin and Pemetrexed

Pemetrexed DRUG

Pemetrexed will be administered.

Cohort 2: Amivantamab plus Carboplatin and Pemetrexed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (23)

City of Hope

Duarte, California, 91010, United States

RECRUITING

City of Hope 1

Irvine, California, 92618, United States

RECRUITING

Providence Cancer Center

Portland, Oregon, 97213, United States

RECRUITING

Providence Oncology and Hematology Care Clinic Westside

Portland, Oregon, 97225, United States

RECRUITING

Princess Margaret Hospital

Toronto, Ontario, M5G 2C1, Canada

RECRUITING

Beijing Cancer Hospital of Peking University

Beijing, 100142, China

RECRUITING

Sichuan Cancer Hospital

Cheng Du Shi, 610044, China

RECRUITING

West China Hospital Sichuan University

Chengdu, 610041, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, 510060, China

RECRUITING

Shandong Cancer Hospital

Jinan, 250117, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, 200433, China

RECRUITING

Tianjin Chest Hospital

Tianjin, 300222, China

RECRUITING

Kyungpook National University Chilgok Hospital

Buk Gu, 41404, South Korea

RECRUITING

Pusan National University Hospital

Busan, 49241, South Korea

RECRUITING

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, 152-703, South Korea

RECRUITING

Hosp. Gral. Univ. Dr. Balmis

Alicante, 03010, Spain

RECRUITING

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007, Spain

RECRUITING

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

Chi Mei Medical Center Liouying Branch

Tainan, 736, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

NTU Biomedical Park Hospital

Zhubei, 302, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

amivantamab; lazertinib; Carboplatin; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: July 28, 2026
• Primary Completion (Estimated): March 2, 2028
• Study Completion (Estimated): April 3, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (7); KR (5); CA (1); TW (4); US (4); ES (2)