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 now · Phase 2
Conditions studied: Carcinoma, Non-Small-Cell Lung
In brief
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).
Key facts
- Study ID
- NCT06667076
- Run by
- Janssen Research & Development, LLC
- People needed
- 480
- Starts
- 2024-12-16
- Expected to finish
- 2030-12-26
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Southern Cancer Center, PC — Daphne, Alabama, United States (enrolling)
- City of Hope Phoenix — Goodyear, Arizona, United States (enrolling)
- Clearview Cancer Institute — Huntsville, Alabama, United States (enrolling)
- City of Hope Corona — Corona, California, United States (enrolling)
- City of Hope — Duarte, California, United States (enrolling)
- Providence Medical Foundation — Fullerton, California, United States (enrolling)
- The Oncology Institute of Hope and Innovation — Cerritos, California, United States (enrolling)
- Los Angeles Cancer Network — Glendale, California, United States (enrolling)
- Glendale Adventist Medical Center — Glendale, California, United States (enrolling)
- Marin Cancer Center — Greenbrae, California, United States (enrolling)
- City of Hope Seacliff — Huntington Beach, California, United States (enrolling)
- City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California, United States (enrolling)
- University of California San Diego Health — La Jolla, California, United States (enrolling)
- City of Hope Antelope Valley — Lancaster, California, United States (enrolling)
- City of Hope Long Beach Elm — Long Beach, California, United States (enrolling)
- Cancer and Blood Specialty Clinic — Los Alamitos, California, United States (enrolling)
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
- Cedars Sinai Medical Center — Los Angeles, California, United States (enrolling)
- Valkyrie Clinical Trials — Los Angeles, California, United States (enrolling)
- Valkyrie Clinical Trials Murrieta — Murrieta, California, United States (enrolling)
- Kaiser Permanente Oakland Medical Center — Oakland, California, United States (enrolling)
- St. Joseph Hospital Center for Cancer Prevention and Treatment — Orange, California, United States (enrolling)
- University of California Irvine — Orange, California, United States (enrolling)
- Sutter Health Palo Alto Medical Foundation — Palo Alto, California, United States (enrolling)
- Kaiser Permanente Roseville Medical Center — Roseville, California, United States (enrolling)
Full record on ClinicalTrials.gov
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