2025-524816-13-00RecruitingPhase 2
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
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: EU CTIS (euclinicaltrials.eu) · Last updated 23 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- First submitted
- 9 Apr 2026
- Start date
- 27 Jul 2026
- Lead sponsor
- Janssen Cilag International
- Diseases
- Lung cancer
- EU CT number
- 2025-524816-13-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 6
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) 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 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General Universitario Dr. Balmis | Alicante | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.