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Study of Amivantamab with Lazertinib or Chemotherapy for EGFR-Mutated Lung Cancer

This study is looking at how well two different treatment combinations work for people with advanced non-small cell lung cancer (NSCLC), a common type of lung cancer. You might be able to join if your cancer has specific changes in a gene called EGFR (Epidermal Growth Factor Receptor), specifically Ex19del or Ex21 L858R. The study is testing amivantamab combined with lazertinib, or amivantamab combined with platinum-based chemotherapy (pemetrexed and carboplatin). Researchers will measure how long people live without their cancer growing or spreading (Progression Free Survival) for up to 4 years and 6 months. The current status of this study is unclear, and it plans to enroll about 480 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 480 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure Progression Free Survival for up to 4 years and 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06667076

A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Recruiting
PHASE2Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~480 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:AmivantamabLazertinibChemotherapy: PemetrexedChemotherapy: Carboplatin

At a glance

Recruiting sites
178 of 203 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS)
Measured over Up to 4 Years and 6 months

Conditions

Carcinoma, Non-Small-Cell Lung

Explore related trials

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Where it's being run

203 sites across 47 states
California36
Florida15
Texas15
New York8
Illinois7
Pennsylvania7
Georgia6
Tennessee6

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy
Epidermal growth factor resistance-mutation (EGFRm) must be an Ex19del or Ex21 L858R substitution, as detected by food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the US), or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. In the European union (EU), the local test must be Conformité Européenne (CE)-marked or an in-house laboratory-developed test from health institutions in the EU in accordance with Article 5(5) of the in vitro diagnostic regulations (IVDR ) 2071/746, as amended
Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated
Any toxicities from prior systemic anticancer therapy must have resolved to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or baseline level (except for alopecia \[any grade\], grade \<=2 peripheral neuropathy, or grade \<=2 hypothyroidism stable on hormone replacement)
Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Exclusion

Medical history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis. Participants with medical history of radiation pneumonitis, including radiation pneumonitis which required steroid treatment, should consult with the medical monitor and eligibility be assessed on a case-by-case basis
Had major surgery excluding placement of vascular access or tumor biopsy or had significant traumatic injury within 4 weeks before the first dose of anticancer treatments or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
Participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy should be treated prior to first dosing)
Received an investigational treatment that has not been cleared (based on at least 5 half lives of any pharmaceutical treatment) before the planned first dose of study treatment or is currently enrolled in an investigational study
Has a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)

What this trial measures

  • Progression Free Survival (PFS)Up to 4 Years and 6 months

    PFS is defined as the time from the date of first dose of any study treatment until the date of objective disease progression or death, whichever occurs first according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1 as assessed by the investigator.