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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT07586202

Registry updated: 2026-09-25
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Description

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.

Interventions

  • Amivantamab (Drug)
    Amivantamab will be administered.
  • Lazertinib (Drug)
    Lazertinib will be administered.
  • Carboplatin (Drug)
    Carboplatin will be administered.
  • Pemetrexed (Drug)
    Pemetrexed will be administered.

Eligibility criteria

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

Conditions

Carcinoma, Non-Small-Cell Lung

Locations

  • City of Hope — Duarte, California, United States
  • City of Hope 1 — Irvine, California, United States
  • Providence Cancer Center — Portland, Oregon, United States
  • Providence Oncology and Hematology Care Clinic Westside — Portland, Oregon, United States
  • Princess Margaret Hospital — Toronto, Ontario, Canada
  • Beijing Cancer Hospital of Peking University — Beijing, China
  • Sichuan Cancer Hospital — Cheng Du Shi, China
  • West China Hospital Sichuan University — Chengdu, China
  • Guangdong Provincial People's Hospital — Guangzhou, China
  • Shandong Cancer Hospital — Jinan, China
  • Shanghai Pulmonary Hospital — Shanghai, China
  • Tianjin Chest Hospital — Tianjin, China
  • Kyungpook National University Chilgok Hospital — Buk Gu, South Korea
  • Pusan National University Hospital — Busan, South Korea
  • Severance Hospital Yonsei University Health System — Seoul, South Korea
  • Samsung Medical Center — Seoul, South Korea
  • Korea University Guro Hospital — Seoul, South Korea
  • Hosp. Gral. Univ. Dr. Balmis — Alicante, Spain
  • Hosp. Gral. Univ. Gregorio Maranon — Madrid, Spain
  • Taichung Veterans General Hospital — Taichung, Taiwan
  • Chi Mei Medical Center Liouying Branch — Tainan, Taiwan
  • Taipei Medical University Hospital — Taipei, Taiwan
  • NTU Biomedical Park Hospital — Zhubei, Taiwan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record