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 · NCT06667076 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
60 locations listed across 34 US states.
- Southern Cancer Center, PC - Daphne, Alabama, United States
- Clearview Cancer Institute - Huntsville, Alabama, United States
- City of Hope Phoenix - Goodyear, Arizona, United States
- The Oncology Institute of Hope and Innovation - Cerritos, California, United States
- City of Hope Corona - Corona, California, United States
- City of Hope - Duarte, California, United States
- Providence Medical Foundation - Fullerton, California, United States
- Oncology Physicians Network Healthcare - Glendale, California, United States
- Los Angeles Cancer Network - Glendale, California, United States
- Glendale Adventist Medical Center - Glendale, California, United States
- Marin Cancer Center - Greenbrae, California, United States
- City of Hope Seacliff - Huntington Beach, California, United States
- City of Hope Orange County Lennar Foundation Cancer Center - Irvine, California, United States
- University of California San Diego Health - La Jolla, California, United States
- City of Hope Antelope Valley - Lancaster, California, United States
- City of Hope Long Beach Elm - Long Beach, California, United States
- Cancer and Blood Specialty Clinic - Los Alamitos, California, United States
- USC Norris Comprehensive Cancer Center - Los Angeles, California, United States
- Cedars Sinai Medical Center - Los Angeles, California, United States
- Valkyrie Clinical Trials - Los Angeles, California, United States
- Valkyrie Clinical Trials Murrieta - Murrieta, California, United States
- Kaiser Permanente Oakland Medical Center - Oakland, California, United States
- St. Joseph Hospital Center for Cancer Prevention and Treatment - Orange, California, United States
- University of California Irvine - Orange, California, United States
- Sutter Health Palo Alto Medical Foundation - Palo Alto, California, United States
- Kaiser Permanente Roseville Medical Center - Roseville, California, United States
- UC Davis Comprehensive Cancer Center - Sacramento, California, United States
- Sutter Institute for Medical Research - Sacramento, California, United States
- California Pacific Medical Center - San Francisco, California, United States
- Kaiser Permanente San Francisco Medical Center - San Francisco, California, United States
- UCSF Zuckerberg San Francisco General Hospital - San Francisco, California, United States
- Sansum Clinic - Santa Barbara, California, United States
- Kaiser Permanente Santa Clara Medical Center - Santa Clara, California, United States
- Providence Medical Foundation 1 - Santa Rosa, California, United States
- City of Hope South Pasadena - South Pasadena, California, United States
- City of Hope Upland - Upland, California, United States
- Kaiser Permanente Northern California - Vallejo, California, United States
- Kaiser Permanente Walnut Creek Medical Center - Walnut Creek, California, United States
- John Muir Health Clinical Research Center - Walnut Creek, California, United States
- National Jewish Health - Denver, Colorado, United States
- Saint Josephs Hospital Cancer Centers of Colorado - Denver, Colorado, United States
- Lutheran Hospital Cancer Centers of Colorado - Golden, Colorado, United States
- Rocky Mountain Cancer Centers - Lone Tree, Colorado, United States
- Yale New Haven Hospital Yale Cancer Center - New Haven, Connecticut, United States
- ChristianaCare Helen F Graham Cancer Center and Research Institute - Newark, Delaware, United States
- MedStar Georgetown University Hospital - Washington D.C., District of Columbia, United States
- Washington DC VA Medical Center - Washington D.C., District of Columbia, United States
- Baptist Lynn Cancer Institute - Boca Raton, Florida, United States
- The Oncology Institute of Hope and Innovation 1 - Fort Lauderdale, Florida, United States
- Florida Cancer Specialists - Fort Myers, Florida, United States
- Univ of Florida - Gainesville, Florida, United States
- Memorial Regional Hospital - Hollywood, Florida, United States
- Baptist MD Anderson Cancer Center - Jacksonville, Florida, United States
- Mayo Clinic - Jacksonville, Florida, United States
- Sylvester Comprehensive Cancer Center - Miami, Florida, United States
- Baptist Health Miami Cancer Institute - Miami, Florida, United States
- AdventHealth Orlando - Orlando, Florida, United States
- Orlando Health Cancer Institute - Orlando, Florida, United States
- Memorial Cancer Institute - Pembroke Pines, Florida, United States
- Florida Cancer Specialists & Research Institute 1 - St. Petersburg, Florida, United States
Showing 60 of 203 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →