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)
A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well amivantamab works with lazertinib or with platinum-based chemotherapy to fight lung cancer. It is for people with non-small cell lung cancer that has spread nearby or to other parts of the body and has certain changes in the EGFR gene.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have non-small cell lung cancer confirmed by a tissue or cell test. The cancer must be advanced or have spread, and treatment aimed at a cure must not be an option.
- Have an EGFR gene change called Ex19del or Ex21 L858R, confirmed by an approved or validated lab test that meets local rules.
- Have at least one tumor that can be measured and has not been treated with radiation.
- Side effects from past cancer medicines must be mild or back to their usual level. Exceptions include hair loss, mild or moderate nerve damage, or mild or moderate low thyroid function stable on hormone treatment.
- Be fully active or able to do light work, with limits only on hard physical activity.
Who can't join
- Have a history of active interstitial lung disease, which causes lung inflammation or scarring, including from medicines or radiation. Past lung inflammation from radiation will be reviewed case by case.
- Have had major surgery or a serious injury within 4 weeks before starting treatment, have not fully healed from surgery, or have surgery planned during the study. A tumor biopsy or placement of a tube to access a vein does not count as major surgery.
- Have uncontrolled pain from the cancer. Painful tumors that can be treated with radiation to ease symptoms should be treated before the first dose.
- Are currently in another study of an experimental treatment, or have not waited long enough for a past experimental treatment to clear from the body.
- Have had or currently have another cancer whose course or treatment could affect the study's safety or treatment results.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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)
Study sites (150)
AL
- Southern Cancer Center, PC · Daphne, AL 36526More trials in Daphne
- Clearview Cancer Institute · Huntsville, AL 35805More trials in Huntsville
AZ
- City of Hope Phoenix · Goodyear, AZ 85338More trials in Goodyear
CA
- The Oncology Institute of Hope and Innovation · Cerritos, CA 90703More trials in Cerritos
- City of Hope Corona · Corona, CA 92882More trials in Corona
- City of Hope · Duarte, CA 91010More trials in Duarte
- Providence Medical Foundation · Fullerton, CA 92835More trials in Fullerton
- Oncology Physicians Network Healthcare · Glendale, CA 91203More trials in Glendale
- Los Angeles Cancer Network · Glendale, CA 91204More trials in Glendale
- Glendale Adventist Medical Center · Glendale, CA 91206More trials in Glendale
- Marin Cancer Center · Greenbrae, CA 94904More trials in Greenbrae
- City of Hope Seacliff · Huntington Beach, CA 92648More trials in Huntington Beach
- City of Hope Orange County Lennar Foundation Cancer Center · Irvine, CA 92618More trials in Irvine
- University of California San Diego Health · La Jolla, CA 92093More trials in La Jolla
- City of Hope Antelope Valley · Lancaster, CA 93534More trials in Lancaster
- City of Hope Long Beach Elm · Long Beach, CA 90813More trials in Long Beach
- Cancer and Blood Specialty Clinic · Los Alamitos, CA 90720More trials in Los Alamitos
- USC Norris Comprehensive Cancer Center · Los Angeles, CA 90033More trials in Los Angeles
- Cedars Sinai Medical Center · Los Angeles, CA 90048More trials in Los Angeles
- Valkyrie Clinical Trials · Los Angeles, CA 90067More trials in Los Angeles
- Valkyrie Clinical Trials Murrieta · Murrieta, CA 92562More trials in Murrieta
- Kaiser Permanente Oakland Medical Center · Oakland, CA 94611More trials in Oakland
- St. Joseph Hospital Center for Cancer Prevention and Treatment · Orange, CA 92868More trials in Orange
- University of California Irvine · Orange, CA 92868More trials in Orange
- Sutter Health Palo Alto Medical Foundation · Palo Alto, CA 94301More trials in Palo Alto
- Kaiser Permanente Roseville Medical Center · Roseville, CA 95661More trials in Roseville
- UC Davis Comprehensive Cancer Center · Sacramento, CA 95630More trials in Sacramento
- Sutter Institute for Medical Research · Sacramento, CA 95816More trials in Sacramento
- California Pacific Medical Center · San Francisco, CA 94115More trials in San Francisco
- Kaiser Permanente San Francisco Medical Center · San Francisco, CA 94115More trials in San Francisco
- UCSF Zuckerberg San Francisco General Hospital · San Francisco, CA 94143More trials in San Francisco
- Sansum Clinic · Santa Barbara, CA 93105More trials in Santa Barbara
- Kaiser Permanente Santa Clara Medical Center · Santa Clara, CA 95051More trials in Santa Clara
- Providence Medical Foundation 1 · Santa Rosa, CA 95403More trials in Santa Rosa
- City of Hope South Pasadena · South Pasadena, CA 91030More trials in South Pasadena
- City of Hope Upland · Upland, CA 91786More trials in Upland
- Kaiser Permanente Northern California · Vallejo, CA 94589More trials in Vallejo
- Kaiser Permanente Walnut Creek Medical Center · Walnut Creek, CA 94596More trials in Walnut Creek
- John Muir Health Clinical Research Center · Walnut Creek, CA 94598More trials in Walnut Creek
CO
- National Jewish Health · Denver, CO 80206More trials in Denver
- Saint Josephs Hospital Cancer Centers of Colorado · Denver, CO 80218More trials in Denver
- Lutheran Hospital Cancer Centers of Colorado · Golden, CO 80401More trials in Golden
- Rocky Mountain Cancer Centers · Lone Tree, CO 80124More trials in Lone Tree
CT
- Yale New Haven Hospital Yale Cancer Center · New Haven, CT 06520More trials in New Haven
DC
- MedStar Georgetown University Hospital · Washington D.C., DC 20007More trials in Washington D.C.
- Washington DC VA Medical Center · Washington D.C., DC 20422More trials in Washington D.C.
DE
- ChristianaCare Helen F Graham Cancer Center and Research Institute · Newark, DE 19713More trials in Newark
FL
- Baptist Lynn Cancer Institute · Boca Raton, FL 33486More trials in Boca Raton
- The Oncology Institute of Hope and Innovation 1 · Fort Lauderdale, FL 33316More trials in Fort Lauderdale
- Florida Cancer Specialists · Fort Myers, FL 33916More trials in Fort Myers
- Univ of Florida · Gainesville, FL 32610More trials in Gainesville
- Memorial Regional Hospital · Hollywood, FL 33021 5421More trials in Hollywood
- Baptist MD Anderson Cancer Center · Jacksonville, FL 32207More trials in Jacksonville
- Mayo Clinic · Jacksonville, FL 32224More trials in Jacksonville
- Sylvester Comprehensive Cancer Center · Miami, FL 33136More trials in Miami
- Baptist Health Miami Cancer Institute · Miami, FL 33176More trials in Miami
- AdventHealth Orlando · Orlando, FL 32803More trials in Orlando
- Orlando Health Cancer Institute · Orlando, FL 32806More trials in Orlando
- Memorial Cancer Institute · Pembroke Pines, FL 33026More trials in Pembroke Pines
- Florida Cancer Specialists & Research Institute 1 · St. Petersburg, FL 33701More trials in St. Petersburg
- Moffitt Cancer Center · Tampa, FL 33612More trials in Tampa
- Florida Cancer Specialists & Research Institute · West Palm Beach, FL 33401More trials in West Palm Beach
GA
- University Cancer And Blood Center LLC · Athens, GA 30607More trials in Athens
- Grady Health System Correll Pavilion · Atlanta, GA 30303More trials in Atlanta
- Piedmont Healthcare · Atlanta, GA 30309More trials in Atlanta
- Piedmont Cancer Institute · Atlanta, GA 30318More trials in Atlanta
- Winship Cancer Institute Emory University · Atlanta, GA 30322More trials in Atlanta
- City of Hope Cancer Center · Newnan, GA 30265More trials in Newnan
IA
- Accellacare of McFarland · Ames, IA 50010More trials in Ames
IL
- Rush University Medical Center Rush University Cancer Center Chicago · Chicago, IL 60607More trials in Chicago
- University of Illinois at Chicago · Chicago, IL 60612More trials in Chicago
- Cancer Care Specialists of Central Illinois · Decatur, IL 62526More trials in Decatur
- Hope and Healing Cancer Services · Hinsdale, IL 60521More trials in Hinsdale
- Illinois Cancer Specialists · Niles, IL 60714More trials in Niles
- Illinois CancerCare · Peoria, IL 61615More trials in Peoria
- City of Hope Chicago · Zion, IL 60099More trials in Zion
IN
- Fort Wayne Medical Oncology and Hematology · Fort Wayne, IN 46804More trials in Fort Wayne
- Investigative Clinical Research of Indiana, LLC · Noblesville, IN 46062More trials in Noblesville
KS
- University of Kansas Cancer Center · Fairway, KS 66205More trials in Fairway
MA
- Boston University Medical Center · Boston, MA 02118More trials in Boston
- Beth Israel Deaconess Medical Center · Boston, MA 02215More trials in Boston
- Dana Farber Cancer Institute · Boston, MA 02215More trials in Boston
MD
- University of Maryland · Baltimore, MD 21201More trials in Baltimore
- Maryland Oncology Hematology P A · Silver Spring, MD 20904More trials in Silver Spring
MI
- University of Michigan Health System · Ann Arbor, MI 48105More trials in Ann Arbor
- Trinity Health St Joseph Mercy Ann Arbor · Ypsilanti, MI 48197More trials in Ypsilanti
MN
- University Of Minnesota · Minneapolis, MN 55455More trials in Minneapolis
- Mayo Clinic Rochester · Rochester, MN 55905More trials in Rochester
MO
- Truman Medical Ctr West · Kansas City, MO 64108More trials in Kansas City
- Oncology Hematology Associates · Springfield, MO 65807More trials in Springfield
- Washington University School Of Medicine · St Louis, MO 63110More trials in St Louis
MS
- Jackson Oncology Associates · Jackson, MS 39202More trials in Jackson
NC
- Atrium Health · Charlotte, NC 28204More trials in Charlotte
- Duke University Medical Center · Durham, NC 27710More trials in Durham
- Regional Medical Oncology Center · Wilson, NC 27893More trials in Wilson
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center · Winston-Salem, NC 27157More trials in Winston-Salem
NH
- Dartmouth Hitchcock Medical Center · Lebanon, NH 03756More trials in Lebanon
NJ
- Hunterdon Hematology Oncology · Flemington, NJ 08822More trials in Flemington
- Morristown Medical Center · Morristown, NJ 07960More trials in Morristown
- Rutgers Cancer Institute of New Jersey · New Brunswick, NJ 08901More trials in New Brunswick
- Overlook Medical Center · Summit, NJ 07901More trials in Summit
- Holy Name Medical Center · Teaneck, NJ 07666More trials in Teaneck
NM
- University of New Mexico · Albuquerque, NM 87102More trials in Albuquerque
NY
- Hematology-Oncology Associates of CNY · East Syracuse, NY 13057More trials in East Syracuse
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island · Mineola, NY 11501More trials in Mineola
- NYU Langone Health Laura and Isaac Perlmutter Cancer Center · New York, NY 10016More trials in New York
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center · New York, NY 10032More trials in New York
- Ellis Hospital · Schenectady, NY 12308More trials in Schenectady
- New York Cancer and Blood Specialists · Shirley, NY 11967More trials in Shirley
- Montefiore Medical Center · The Bronx, NY 10461More trials in The Bronx
- Clinical Research Alliance Inc · Westbury, NY 11590More trials in Westbury
OH
- University of Cincinnati · Cincinnati, OH 45219More trials in Cincinnati
- Cincinnati Veterans Affairs Medical Center · Cincinnati, OH 45220More trials in Cincinnati
OR
- Oncology Associates of Oregon PC Willamette Valley Cancer Institute · Eugene, OR 97401More trials in Eugene
- Oregon Health And Science University · Portland, OR 97239More trials in Portland
PA
- Lankenau Institute for Medical Research Main Line Health Bryn Mawr Hospital · Bryn Mawr, PA 19010More trials in Bryn Mawr
- Lankenau Institute for Medical Research Main Line Health Paoli Hospital · Paoli, PA 19301More trials in Paoli
- Philadelphia VA Medical Center · Philadelphia, PA 19104More trials in Philadelphia
- Thomas Jefferson University Hospital · Philadelphia, PA 19107More trials in Philadelphia
- Jefferson Health Northeast · Philadelphia, PA 19114More trials in Philadelphia
- McGlinn Cancer Institute Reading Hospital · West Reading, PA 19611More trials in West Reading
- Lankenau Institute for Medical Research · Wynnewood, PA 19096More trials in Wynnewood
SC
- Medical University of South Carolina · Charleston, SC 29425More trials in Charleston
SD
- Avera Medical Group · Sioux Falls, SD 57105More trials in Sioux Falls
TN
- Tennessee Oncology - Chattanooga · Chattanooga, TN 37404More trials in Chattanooga
- Tennessee Cancer Specialists · Knoxville, TN 37909More trials in Knoxville
- University of Tennessee · Knoxville, TN 37920More trials in Knoxville
- Baptist Cancer Center · Memphis, TN 38120More trials in Memphis
- SCRI Oncology Partners · Nashville, TN 37203More trials in Nashville
- Tennessee Oncology · Nashville, TN 37203More trials in Nashville
TX
- Texas Oncology South · Austin, TX 78745More trials in Austin
- Parkland Health and Hospital System · Dallas, TX 75235More trials in Dallas
- Texas Oncology DFW · Dallas, TX 75246More trials in Dallas
- UT Southwestern Medical Center · Dallas, TX 75390More trials in Dallas
- Renovatio Clinical · El Paso, TX 79915More trials in El Paso
- JPS Health Network · Fort Worth, TX 76104More trials in Fort Worth
- MD Anderson Cancer Center · Houston, TX 77030More trials in Houston
- Oncology Consultants Texas · Houston, TX 77030More trials in Houston
- Texas Oncology Odessa-West Texas Cancer Center · Odessa, TX 79761More trials in Odessa
- Texas Oncology San Antonio Northeast · San Antonio, TX 78217More trials in San Antonio
- Community Clinical Trials · Spring, TX 77389More trials in Spring
- Renovatio Clinical 1 · The Woodlands, TX 77380More trials in The Woodlands
- The University of Texas Health Science Center at Tyler · Tyler, TX 75701More trials in Tyler
- Texas Oncology - Northeast · Tyler, TX 75702More trials in Tyler
- Texas Oncology-Gulf Coast · Webster, TX 77598More trials in Webster
UT
- Huntsman Cancer Institute · Salt Lake City, UT 84112More trials in Salt Lake City
VA
- Virginia Cancer Specialists · Fairfax, VA 22031More trials in Fairfax
WA
- Vista Oncology · Olympia, WA 98506More trials in Olympia
- Summit Cancer Centers · Spokane, WA 99208More trials in Spokane
- Northwest Cancer Specialists - Vancouver · Vancouver, WA 98684More trials in Vancouver