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Compares treatment options for Recurrent Lung Non-Small Cell Carcinoma
Official title Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Trial)
ClinicalTrials.gov ID: NCT05642572
What this study is testing
What is Capmatinib?
Capmatinib is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent lung non-small cell carcinoma.
Also referred to as INC-280, INC280.
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 Lung-MAP treatment trial test the combination of targeted drugs (capmatinib, osimertinib, and/or ramucirumab) in treating patients with non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and that has EGFR and MET gene changes. Capmatinib and osimertinib are in a class of medications called kinase inhibitors.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III...
- Participants must have been assigned to S1900G by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to...
- Participants must have documentation of NSCLC with a sensitizing EGFR mutation and have radiologically or clinically progressed (in the opinion of...
- Participants must have a MET amplification determined by tissue-based or blood-based (circulating tumor DNA [ctDNA]) next generation sequencing (NGS)...
- Note: Participants previously tested for and determined to have MET amplified NSCLC, at the time of progression on osimertinib, outside of LUNGMAP...
You likely can't join if
- Participants must not have received an anti-VEGF or VEGFR inhibitor or MET inhibitor
- Participants must not have received any anti-cancer drug (investigational or standard of care drug, except osimertinib) within 21 days prior to...
- Note: osimertinib may continue up to the day prior to study treatment initiation
- Participants must not have received any radiation therapy within 14 days prior to sub-study randomization
- Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while...
- Participants must not have had a major surgery within 14 days prior to sub-study randomization. Participants must have fully recovered from the...
See the full eligibility criteria
Who can join
- Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer...
- Participants must have been assigned to S1900G by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900G is determined by the LUNGMAP protocol
- Participants must have documentation of NSCLC with a sensitizing EGFR mutation and have radiologically or clinically progressed (in the opinion of the treating physician) on osimertinib, alone or in combination with...
- Participants must have a MET amplification determined by tissue-based or blood-based (circulating tumor DNA [ctDNA]) next generation sequencing (NGS) assay. MET amplifications may have been determined based on tissue...
- Note: Participants previously tested for and determined to have MET amplified NSCLC, at the time of progression on osimertinib, outside of LUNGMAP, must also submit tissue for central FMI testing on the LUNGMAP...
- Participants must have either measurable disease or non-measurable disease documented by CT or MRI. The CT from a combined PET/CT may be used to document only non-measurable disease unless it is of diagnostic quality...
- Participants must have a CT with contrast or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study randomization
- Participants with symptomatic CNS metastasis (brain metastases or leptomeningeal disease) must be neurologically stable and have a stable or decreasing corticosteroid requirement for at least 5 days before sub-study...
- Participants must have recovered (=\< grade 1) from any side effects of prior therapy, except for alopecia and vitiligo
- Participants must be able to swallow tablets whole
- Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to sub-study randomization)
- Hemoglobin \< 9.0 g/dL (within 28 days prior to sub-study randomization)
- Platelets \>= 100 x 10\^3/uL (within 28 days prior to sub-study randomization)
- Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to sub-study randomization). Participants with history of Gilbert's disease must have total...
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x institutional ULN. Participants with history of liver metastasis must have AST =\< 5 x ULN (within 28 days prior to sub-study randomization)
- Participants must have a serum creatinine =\ = 50 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to sub-study randomization
- Participants' most recent Zubrod performance status must be 0-1 and be documented within 28 days prior to sub-study randomization
- Participants must have an electrocardiogram (ECG) performed, with a Fridericia's Correction Formula (QTcF) =\< 470 msec, within 28 days prior to sub-study randomization. It is suggested that a local cardiologist review...
- Participants must have a completed medical history and physical exam within 28 days prior to sub-study randomization
- Participants must have a urinalysis performed 28 days prior to sub-study randomization. Participant must have a urinary protein =\ = 2+, then a 24-hour urine is to be collected and demonstrate \< 2000 mg of protein in...
- Participants must have an International Normalized Ratio (INR) =\< 1.5 seconds above the institutional upper limit of normal (IULN) (unless receiving anticoagulation therapy) documented within 28 days to sub-study...
- Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy at randomization and have undetectable viral load within 6 months prior to sub-study randomization
- Participants must have asymptomatic serum amylase =\< 2 x ULN and serum lipase =\< ULN obtained within 28 days prior to sub-study randomization. Asymptomatic is defined as having no signs and/ or symptoms suggesting...
- Participants must have adequate cardiac function. 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...
- 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
- Note: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been...
- 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
- Participants with impaired decision-making capacity must not have a neurological or psychological condition that precludes their safe participation in the study (e.g., tracking pill consumption and reporting adverse...
What rules you out
- Participants must not have received an anti-VEGF or VEGFR inhibitor or MET inhibitor
- Participants must not have received any anti-cancer drug (investigational or standard of care drug, except osimertinib) within 21 days prior to sub-study randomization
- Note: osimertinib may continue up to the day prior to study treatment initiation
- Participants must not have received any radiation therapy within 14 days prior to sub-study randomization
- 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 a major surgery within 14 days prior to sub-study randomization. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator
- Participants must not have received a live attenuated vaccination within 28 days prior to sub-study randomization. All COVID-19 vaccines that have received Food and Drug Administration (FDA) approval or FDA emergency...
- Participants must not have received strong inducers of CYP3A4 (including herbal supplements such as St. John's Wort); CYP3A4 inhibitors; CYP1A2 substrates; P-gp and BCRP substrates; sensitive substrates of MATE1 and...
- Participants must not have uncontrolled blood pressure and hypertension within 28 days prior to sub-study randomization
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Daphne, Alabama, United States
- Fairhope, Alabama, United States
- Mobile, Alabama, United States
- Saraland, Alabama, United States
- Anchorage, Alaska, United States
- Kingman, Arizona, United States
- Phoenix, Arizona, United States
- Jonesboro, Arkansas, United States
- Little Rock, Arkansas, United States
- Anaheim, California, United States
- Arroyo Grande, California, United States
- Auburn, California, United States
- Baldwin Park, California, United States
- Bellflower, California, United States
- Berkeley, California, United States
- Beverly Hills, California, United States
- Carmichael, California, United States
- Elk Grove, California, United States
- Fontana, California, United States
- Fremont, California, United States
+ 343 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Daphne, Alabama, United States; Fairhope, Alabama, United States; Mobile, Alabama, United States; Saraland, Alabama, United States; Anchorage, Alaska, United States; Kingman, Arizona, United States and 357 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.