NCT07586202RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 68 (estimated)
- First submitted
- 8 May 2026
- Start date
- 28 Jul 2026
- Primary completion date
- 2 Mar 2028
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Lung cancer
- NCT number
- NCT07586202
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 68
- From 28 Jul 2026 to the primary completion date, 2 Mar 2028
- 27 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Beijing Cancer Hospital of Peking University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Sichuan Cancer Hospital Coordinator of this site? Confirm its status | Cheng Du Shi | China | Recruiting |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Shandong Cancer Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Shanghai Pulmonary Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Tianjin Chest Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| Hosp. Gral. Univ. Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Recruiting |
| Hosp Univ Vall D Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hosp. Gral. Univ. Gregorio Maranon Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Buk Gu | South Korea | Recruiting |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
| Chi Mei Medical Center Liouying Branch Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| Taipei Medical University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| NTU Biomedical Park Hospital Coordinator of this site? Confirm its status | Zhubei | Taiwan | Recruiting |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| Virginia Cancer Specialists Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| City of Hope 1 Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| Providence Oncology and Hematology Care Clinic - Westside Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Providence Cancer Center Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Stanford Cancer Institute Coordinator of this site? Confirm its status | Stanford | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.