A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC
A Phase 2 Study Evaluating the Safety and Efficacy of Neoadjuvant Amivantamab in Combination With Lazertinib or Chemotherapy in Resectable EGFR-Mutated Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Janssen Research & Development, LLC
- Enrolment target
- 68
- Started
- 28 July 2026
- Main results due
- 2 March 2028
- Study sites
- 23
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
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 sites(23)
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
Beijing Cancer Hospital of Peking University
Beijing, China
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
Shanghai Pulmonary Hospital
Shanghai, 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
Severance Hospital Yonsei University Health System
Seoul, 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
Showing 23 of 23 sites. 23 of the 23 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07586202. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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