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New treatment option for Lung Non-Small Cell Carcinoma
Official title Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has Increased Copies of the MET Gene (An Expanded Lung-MAP Treatment Trial)
ClinicalTrials.gov ID: NCT06116682
What this study is testing
What is Amivantamab?
Amivantamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for lung non-small cell carcinoma.
Also referred to as Amivantamab-vmjw, Anti-EGFR/c-Met Bispecific Antibody JNJ-61186372.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II Expanded Lung-MAP treatment trial tests how well amivantamab-subcutaneous (SC) works in treating patients patients with MET amplification non-small cell lung cancer. Amivantamab-SC is a drug that reduces extra copies of the MET gene, a change present in your tumor.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have been assigned to S1900J by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to...
- 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...
- 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...
- Participants with asymptomatic CNS metastasis (brain metastases or leptomeningeal disease) must be clinically stable and asymptomatic for at least 14...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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 how well it works assessment of...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Jonesboro, Arkansas, United States
- Little Rock, Arkansas, United States
- Auburn, California, United States
- Berkeley, California, United States
- Fremont, California, United States
- La Jolla, California, United States
- Loma Linda, California, United States
- Modesto, California, United States
- Palo Alto, California, United States
- Rancho Mirage, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- San Mateo, California, United States
- Santa Rosa, California, United States
- Sunnyvale, California, United States
- Vallejo, California, United States
- Aurora, Colorado, United States
- Colorado Springs, Colorado, United States
- Fort Collins, Colorado, United States
+ 194 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jonesboro, Arkansas, United States; Little Rock, Arkansas, United States; Auburn, California, United States; Berkeley, California, United States; Fremont, California, United States; La Jolla, California, United States and 208 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.