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Clinical Trials/2025-524816-13-00
2025-524816-13-00RecruitingPhase 2

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

Janssen Cilag International3 sites in 1 country6 target enrollmentStarted: July 1, 2026Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Enrollment
6
Locations
3
Primary Endpoint
MPR (≤10% residual cancer cells in the surgical specimen, per independent centralized pathology review)
Study OverviewEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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 Criteria

  • •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

Arms & Interventions

JNJ-73841937

Test

Intervention: JNJ-73841937 (Drug)

JNJ-61186372

Test

Intervention: JNJ-61186372 (Drug)

Outcomes

Primary Outcomes

MPR (≤10% residual cancer cells in the surgical specimen, per independent centralized pathology review)

MPR (≤10% residual cancer cells in the surgical specimen, per independent centralized pathology review)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

CTIS Point of Contact

Scientific

Janssen Cilag International

Study Sites (3)

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