Clinical trial Recruiting at 250 sites Phase 2 Interventional Ages 18 and up

Targeted treatment for advanced lung cancer with MET gene amplification

Official title: A Phase II Study of Amivantamab SC (Subcutaneous) in Participants With MET Amplification-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)

Run by SWOG Cancer Research Network · NCT06116682 · Data updated 2026-11-12

This study is testing if a new treatment called amivantamab can help people with advanced lung cancer that has extra copies of the MET gene feel better and live longer.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment88 (estimated)
SponsorSWOG Cancer Research Network
Research network
Drugs / interventionstepotinib, capmatinib, crizotinib, chemotherapy, immunotherapy, radiation, prednisone, amivantamab
Locations271 sites (Jonesboro, Arkansas and 270 other locations)
StatusRecruiting
StartedNovember 19, 2024
Main results expectedMay 31, 2028
Study endsMay 31, 2028
Registry record updatedOctober 9, 2026
Trial IDNCT06116682 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with advanced non-small cell lung cancer who have documented MET amplification and measurable disease.

Probably not a fit

Patients without MET amplification or those with non-measurable disease may not benefit from this treatment.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial evaluates the effectiveness of amivantamab-subcutaneous (SC) in treating patients with advanced non-small cell lung cancer (NSCLC) that has increased copies of the MET gene. The study aims to assess the objective response rate, progression-free survival, overall survival, and the duration of response among participants. Patients will receive amivantamab-SC on specific days during 28-day cycles, with imaging and blood sample collection throughout the trial. Additionally, the study includes translational medicine objectives to collect and analyze genetic material for future research.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with MET amplification in their lung cancer.

How similar studies have gone: Other studies targeting genetic mutations in lung cancer have shown promising results, indicating potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Participants must have been assigned to S1900J by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900J is determined by the LUNGMAP protocol
* Participants must have documentation of NSCLC with MET amplification determined by FMI tissue-based next generation sequencing (NGS) assay
* Participants must have measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT may be used to document measurable disease ONLY if it is of diagnostic quality: otherwise, it may be used to document non-measurable disease only. Measurable disease must be assessed within 28 days prior to sub-study registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to sub-study registration. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to sub-study registration to be considered measurable
* Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study registration
* Participants with asymptomatic CNS metastasis (brain metastases or leptomeningeal disease) must be clinically stable and asymptomatic for at least 14 days prior to sub-study registration

  * NOTE: Participants can be on a low-dose corticosteroid treatment (≤ 10 mg prednisone or equivalent) for at least 14 days prior to study treatment
* Participants must not have other known actionable oncogenic alterations, such as (but not limited to) EGFR sensitizing mutations, EGFR T790M mutation, MET Exon-14 skipping mutant NSCLC, ALK gene fusion, ROS1 gene rearrangement, RET gene rearrangement, NTRK rearrangement, HER2 mutation, KRAS activating mutations, and BRAF V600E mutation
* Participants must have progressed (in the opinion of the treating physician) following the most recent line of therapy
* Participants must have received at least one line of systemic treatment for Stage IV or recurrent NSCLC
* Participants must have recovered (≤ Grade 1) from any side effects of prior therapy. The exception is if a side effect from a prior treatment is known to be permanent without expected further recovery or resolution (i.e., endocrinopathy from immunotherapy or cisplatin neurotoxicity)
* Participants must not have been previously treated for any cancer with MET tyrosine kinase inhibitors (TKIs) such as tepotinib, capmatinib, and crizotinib
* Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration
* Participants must not have a prior treatment with anti-PD-1 or anti-PD-L1 antibody within 6 weeks of sub-study registration
* Participants must not have received any radiation therapy within 14 days prior to sub-study registration
* Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study
* Participants must not have had major surgery excluding placement of vascular access or tumor biopsy, or had significant traumatic injury within 28 days prior to sub-study registration, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study

  * NOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate
* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to sub-study registration)
* Hemoglobin \>= 10.0 g/dL (within 28 days prior to sub-study registration)
* Platelets ≥ 75 x 10\^3/uL (within 28 days prior to sub-study registration)
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to sub-study registration)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × institutional ULN. Participants with history of liver metastasis must have AST and ALT ≤ 5 x ULN (within 28 days prior to sub-study registration)
* Participants must have a serum creatinine ≤ the institutional upper limit of normal (IULN) or calculated creatinine clearance ≥ 45 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to sub-study registration. For creatinine clearance formula see the tools on the CRA Workbench
* Participants' most recent Zubrod performance status must be 0-2 and be documented within 28 days prior to sub-study registration
* Participants must have a completed medical history and physical exam within 28 days prior to sub-study registration
* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better
* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy and have undetectable viral load test on the most recent test results obtained within 6 months prior to sub-study registration
* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to sub-study registration
* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to sub-study registration
* Participants with known diabetes as determined by the treating investigator must show evidence of controlled disease within 14 days prior to sub-study registration
* Participants of reproductive potential must have a negative serum pregnancy test within 7 days prior to sub-study registration
* Participants must not have other clinically active infectious liver disease
* Participants must not have clinically significant hypertension within 28 days prior to sub-study registration as determined by the treating investigator
* Participants must not have a history of pneumonitis that required drug therapy or an active symptomatic interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis
* Participants must not have ongoing or active infection or be diagnosed or suspected viral infection as determined by the treating investigator. NOTE: Participants that have an infection requiring antimicrobial therapy will be required to complete antibiotics 1 week prior to starting treatment
* Participants must not have active bleeding diathesis as determined by the treating investigator
* Participants must not have impaired oxygenation requiring continuous oxygen supplementation as determined by the treating investigator
* Participants must not have psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements as determined by the treating investigator
* Participants must not have any ophthalmologic condition that is unstable in the opinion of the treating investigator
* Participants must not be pregnant or breastfeeding (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
* Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)
* Participants must also be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System
* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines

  * NOTE: Participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

Where it's running

  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
    Jonesboro, Arkansas, United States
    Recruiting
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas, United States
    Recruiting
  • Sutter Auburn Faith Hospital
    Auburn, California, United States
    Recruiting
  • Alta Bates Summit Medical Center-Herrick Campus
    Berkeley, California, United States
    Recruiting
  • Palo Alto Medical Foundation-Fremont
    Fremont, California, United States
    Recruiting
  • UC San Diego Moores Cancer Center
    La Jolla, California, United States
    Recruiting
Show 44 more locations
  • Loma Linda University Medical Center
    Loma Linda, California, United States
    Recruiting
  • Memorial Medical Center
    Modesto, California, United States
    Recruiting
  • Palo Alto Medical Foundation Health Care
    Palo Alto, California, United States
    Recruiting
  • Sutter Roseville Medical Center
    Roseville, California, United States
    Recruiting
  • Sutter Medical Center Sacramento
    Sacramento, California, United States
    Recruiting
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California, United States
    Recruiting
  • California Pacific Medical Center-Pacific Campus
    San Francisco, California, United States
    Recruiting
  • Mills Health Center
    San Mateo, California, United States
    Recruiting
  • Kaiser San Rafael-Gallinas
    San Rafael, California, United States
    Recruiting
  • Sutter Pacific Medical Foundation
    Santa Rosa, California, United States
    Recruiting
  • Palo Alto Medical Foundation-Sunnyvale
    Sunnyvale, California, United States
    Recruiting
  • Sutter Solano Medical Center/Cancer Center
    Vallejo, California, United States
    Recruiting
  • Rocky Mountain Regional VA Medical Center
    Aurora, Colorado, United States
    Recruiting
  • UCHealth Memorial Hospital Central
    Colorado Springs, Colorado, United States
    Recruiting
  • Memorial Hospital North
    Colorado Springs, Colorado, United States
    Recruiting
  • Poudre Valley Hospital
    Fort Collins, Colorado, United States
    Recruiting
  • Cancer Care and Hematology-Fort Collins
    Fort Collins, Colorado, United States
    Recruiting
  • UCHealth Greeley Hospital
    Greeley, Colorado, United States
    Recruiting
  • Medical Center of the Rockies
    Loveland, Colorado, United States
    Recruiting
  • Smilow Cancer Hospital-Derby Care Center
    Derby, Connecticut, United States
    Recruiting
  • Smilow Cancer Hospital Care Center-Fairfield
    Fairfield, Connecticut, United States
    Recruiting
  • Smilow Cancer Hospital Care Center - Guilford
    Guilford, Connecticut, United States
    Recruiting
  • Yale University
    New Haven, Connecticut, United States
    Recruiting
  • Yale-New Haven Hospital North Haven Medical Center
    North Haven, Connecticut, United States
    Recruiting
  • Smilow Cancer Hospital Care Center-Trumbull
    Trumbull, Connecticut, United States
    Recruiting
  • Smilow Cancer Hospital-Waterbury Care Center
    Waterbury, Connecticut, United States
    Recruiting
  • Bayhealth Hospital Kent Campus
    Dover, Delaware, United States
    Recruiting
  • Bayhealth Hospital Sussex Campus
    Milford, Delaware, United States
    Recruiting
  • Malcom Randall Veterans Administration Medical Center
    Gainesville, Florida, United States
    Recruiting
  • Mayo Clinic in Florida
    Jacksonville, Florida, United States
    Recruiting
  • Emory University Hospital Midtown
    Atlanta, Georgia, United States
    Recruiting
  • Emory University Hospital/Winship Cancer Institute
    Atlanta, Georgia, United States
    Recruiting
  • Northeast Georgia Medical Center-Gainesville
    Gainesville, Georgia, United States
    Recruiting
  • Hawaii Cancer Care Inc - Waterfront Plaza
    Honolulu, Hawaii, United States
    Recruiting
  • Queen's Cancer Cenrer - POB I
    Honolulu, Hawaii, United States
    Recruiting
  • Queen's Medical Center
    Honolulu, Hawaii, United States
    Recruiting
  • Straub Clinic and Hospital
    Honolulu, Hawaii, United States
    Recruiting
  • Queen's Cancer Center - Kuakini
    Honolulu, Hawaii, United States
    Recruiting
  • Kapiolani Medical Center for Women and Children
    Honolulu, Hawaii, United States
    Recruiting
  • Hawaii Cancer Care - Westridge
    ‘Aiea, Hawaii, United States
    Recruiting
  • Pali Momi Medical Center
    ‘Aiea, Hawaii, United States
    Recruiting
  • The Queen's Medical Center - West Oahu
    ‘Ewa Beach, Hawaii, United States
    Recruiting
  • Saint Alphonsus Cancer Care Center-Boise
    Boise, Idaho, United States
    Recruiting
  • Saint Alphonsus Cancer Care Center-Caldwell
    Caldwell, Idaho, United States
    Recruiting

+221 more sites. See ClinicalTrials.gov for the full list.

Study contacts

  • Principal investigator: Shirish Gadgeel — SWOG Cancer Research Network

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.