Frontlight ResearchEarly access
Taking people in SpainPhase 2
Amivantamab with lazertinib or chemotherapy before surgery for EGFR-mutated lung cancer
Tests amivantamab with lazertinib or chemotherapy before surgery in adults with EGFR-mutated lung cancer.
Key facts
- Who runs it
- Janssen Cilag International
- Where
- Alicante, Barcelona, and Madrid, SpainSee the 3 sites
- Trial code
- Registry title
- 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
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 6 people, planned
- Started
- 27 Jul 2026
- Expected to end
- 1 Jul 2028
- Type of study
- Interventional
- Record updated
- 23 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with lung cancer (non-small cell, nonsquamous) that surgery can fully remove, with an EGFR Exon 19del or Exon 21 L858R change, who have not yet had cancer treatment.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Nonsquamous non-small cell lung cancer, Stage II-IIIB N2, that can be completely removed by surgery
- Earlier treatment
- Cannot have had any drug treatment for lung cancer before, including EGFR-TKI therapy, chemotherapy, biologic therapy, immunotherapy or any investigational drug
- Biomarker or test result
- EGFR Exon 19del or Exon 21 L858R mutation, found by local gene testing; no other main driver gene changes
Main reasons for not taking part
- Uncontrolled illness
- Past or current interstitial lung disease or pneumonitis
- Known allergy or intolerance to the study drugs
- Other main driver gene changes such as ALK, MET, HER2, ROS1, NTRK, BRAF, RET or KRAS
- Any earlier drug treatment for lung cancer
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in Spain
- Hospital General Universitario Dr. BalmisAlicante, SpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital General Universitario Gregorio MarañónMadrid, SpainTaking people
About the trial
What the trial wants to find out
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
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Amivantamab with lazertinib or chemotherapy before surgery for EGFR-mutated lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 23 October 2026