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Clinical Trials in the USA / NCT06667076
Recruiting Phase 2

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)

NCT06667076 · tracked via the Priya Life Science USA tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 2
Started
2024-12-16
Last updated
2026-08-28

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

Amivantamab →Lazertinib →Chemotherapy: PemetrexedChemotherapy: Carboplatin

Amivantamab: Amivantamab will be administered.

Lazertinib: Lazertinib tablet will be administered.

Chemotherapy: Pemetrexed: Pemetrexed will be administered.

Chemotherapy: Carboplatin: Carboplatin will be administered.

Study summary

The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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)

Primary outcome measure(s)

Trial sites (203)

FacilityCityRegionStatus
Southern Cancer Center, PC Daphne Alabama Recruiting
Clearview Cancer Institute Huntsville Alabama Recruiting
City of Hope Phoenix Goodyear Arizona Recruiting
The Oncology Institute of Hope and Innovation Cerritos California Recruiting
City of Hope Corona Corona California Recruiting
City of Hope Duarte California Recruiting
Providence Medical Foundation Fullerton California Recruiting
Oncology Physicians Network Healthcare Glendale California Completed
Los Angeles Cancer Network Glendale California Recruiting
Glendale Adventist Medical Center Glendale California Recruiting
Marin Cancer Center Greenbrae California Recruiting
City of Hope Seacliff Huntington Beach California Recruiting
City of Hope Orange County Lennar Foundation Cancer Center Irvine California Recruiting
University of California San Diego Health La Jolla California Recruiting
City of Hope Antelope Valley Lancaster California Recruiting
City of Hope Long Beach Elm Long Beach California Recruiting
Cancer and Blood Specialty Clinic Los Alamitos California Recruiting
USC Norris Comprehensive Cancer Center Los Angeles California Recruiting
Cedars Sinai Medical Center Los Angeles California Recruiting
Valkyrie Clinical Trials Los Angeles California Recruiting
Valkyrie Clinical Trials Murrieta Murrieta California Recruiting
Kaiser Permanente Oakland Medical Center Oakland California Completed
St. Joseph Hospital Center for Cancer Prevention and Treatment Orange California Recruiting
University of California Irvine Orange California Recruiting
Sutter Health Palo Alto Medical Foundation Palo Alto California Recruiting
Kaiser Permanente Roseville Medical Center Roseville California Completed
UC Davis Comprehensive Cancer Center Sacramento California Recruiting
Sutter Institute for Medical Research Sacramento California Recruiting
California Pacific Medical Center San Francisco California Recruiting
Kaiser Permanente San Francisco Medical Center San Francisco California Completed
UCSF Zuckerberg San Francisco General Hospital San Francisco California Recruiting
Sansum Clinic Santa Barbara California Recruiting
Kaiser Permanente Santa Clara Medical Center Santa Clara California Recruiting
Providence Medical Foundation 1 Santa Rosa California Recruiting
City of Hope South Pasadena South Pasadena California Recruiting
City of Hope Upland Upland California Recruiting
Kaiser Permanente Northern California Vallejo California Recruiting
Kaiser Permanente Walnut Creek Medical Center Walnut Creek California Recruiting
John Muir Health Clinical Research Center Walnut Creek California Recruiting
National Jewish Health Denver Colorado Completed

+ 163 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06667076 on ClinicalTrials.gov ↗ ← All trials in the USA