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
Key facts
- Where
- Alicante, Barcelona és Madrid, SpanyolországSee the 3 sites
- Phase
- 2. fázis
Where in Spanyolország
- Hospital General Universitario Dr. BalmisAlicante, SpanyolországTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországTaking people
- Hospital General Universitario Gregorio MarañónMadrid, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Cilag International
- Trial code
- EU 2025-524816-13-00
- Record updated
- 2026. október 23.
- Original description
To evaluate the antitumor effect of amivantamab in combination with lazertinib or carboplatin and pemetrexed in participants with resectable, EGFRmutated, Stage II-IIIB NSCLC in the neoadjuvant settingRead full original descriptionShow less
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
To evaluate the antitumor effect of amivantamab in combination with lazertinib or carboplatin and pemetrexed in participants with resectable, EGFRmutated, Stage II-IIIB NSCLC in the neoadjuvant setting
Inclusion: Participant must have histologically or cytologically confirmed nonsquamous 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; 3.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: 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.