A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC
Recruiting now · Phase 2
Conditions studied: Carcinoma, Non-Small-Cell Lung
In brief
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.
Key facts
- Study ID
- NCT07586202
- Run by
- Janssen Research & Development, LLC
- People needed
- 68
- Starts
- 2026-07-28
- Expected to finish
- 2028-04-03
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Princess Margaret Hospital — Toronto, Ontario, Canada (enrolling)
- West China Hospital Sichuan University — Chengdu, China (enrolling)
- Guangdong Provincial People's Hospital — Guangzhou, China (enrolling)
- Samsung Medical Center — Seoul, South Korea (enrolling)
- Hosp. Gral. Univ. Dr. Balmis — Alicante, Spain (enrolling)
- Hosp. Gral. Univ. Gregorio Maranon — Madrid, Spain (enrolling)
- Chi Mei Medical Center Liouying Branch — Tainan, Taiwan (enrolling)
- Taipei Medical University Hospital — Taipei, Taiwan (enrolling)
Full record on ClinicalTrials.gov
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