A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAmivantamab and Lazertinib

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 25, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 2

Interventional

Where is it offered?23 U.S. locations

Locations may change over time.

Who runs it?Janssen Research & Development, LLC

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Janssen Research & Development, LLC
Interventions being studied: Drug: Amivantamab; Drug: Lazertinib; Drug: Carboplatin; Drug: Pemetrexed

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Early-stage or resectable→

Biomarkers

EGFR→

Treatment approach

Chemotherapy→

Study topics

Before surgery (neoadjuvant)→After surgery (adjuvant)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

City of HopeDuarte, California
City of Hope 1Irvine, California
Providence Cancer CenterPortland, Oregon
Providence Oncology and Hematology Care Clinic WestsidePortland, Oregon
Princess Margaret HospitalToronto, Ontario
Beijing Cancer Hospital of Peking UniversityBeijing
Sichuan Cancer HospitalCheng Du Shi
West China Hospital Sichuan UniversityChengdu
Guangdong Provincial People's HospitalGuangzhou
Shandong Cancer HospitalJinan
Shanghai Pulmonary HospitalShanghai
Tianjin Chest HospitalTianjin

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 25, 2026. Always confirm current availability with the study team.

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