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New treatment option for Recurrent Lung Non-Small Cell Carcinoma
Official title Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial)
ClinicalTrials.gov ID: NCT06031688
What this study is testing
What is Ramucirumab?
Ramucirumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for recurrent lung non-small cell carcinoma.
Also referred to as Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B, Cyramza.
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 tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after a period of improvement (recurrent). Tepotinib is used in patients whose cancer has a mutated (changed) form of a gene called MET.
- 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
- Participants must have been assigned to S1900K by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to...
- Participants must have documentation of stage IV or recurrent NSCLC with a MET exon 14 skipping mutation determined by tissue-based or blood-based...
- NGS test results from tissue submitted for LUNGMAP screening, or
- Submitted documentation in the LUNGMAP Rave Electronic Data Capture System of a MET exon 14 skipping mutation from a previously completed tissue or...
- Participants must have measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT may be used to...
See the full eligibility criteria
Who can join
- Participants must have been assigned to S1900K by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900K is determined by the LUNGMAP protocol
- Participants must have documentation of stage IV or recurrent NSCLC with a MET exon 14 skipping mutation determined by tissue-based or blood-based (circulating tumor DNA [ctDNA]) next generation sequencing (NGS) assay...
- NGS test results from tissue submitted for LUNGMAP screening, or
- Submitted documentation in the LUNGMAP Rave Electronic Data Capture System of a MET exon 14 skipping mutation from a previously completed tissue or blood-based NGS test
- 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 randomization
- Participants must not have leptomeningeal disease, spinal cord compression or brain metastases unless:
- Metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 3 days following the stereotactic radiation and/or 14 days following whole brain radiation, and prior to...
- Participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study randomization
- Participants must not have other known actionable oncogenic alterations, such as (but not limited to) EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS1 gene rearrangement, RET gene rearrangement...
- Participants who have received at least one line of systemic treatment for stage IV or recurrent NSCLC must have progressed (in the opinion of the treating physician) following the most recent line of therapy...
- Participants may have received any number of lines of therapy for stage IV or recurrent NSCLC (including zero) and must be able to report prior treatment information
- Participants must have recovered (=\< grade 1) from any side effects of prior therapy for NSCLC except alopecia and vitiligo
- Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study randomization
- Participants must not have received treatment with prior MET inhibitor therapies (e.g., crizotinib, tivantinib, savolitinib, tepotinib, cabozantinib, and foretinib).
- Participants must not have received treatment with prior angiogenesis inhibitor therapies (including but not limited to bevacizumab and ramucirumab)
- Participants must not have a history of interstitial lung disease that required steroid treatment
- Participants must not have received any radiation therapy within 7 days prior to sub-study randomization with the exceptions of
- Stereotactic radiation to CNS metastases which must have been completed at least 3 days prior to sub-study randomization and
- Palliative radiotherapy to bone metastases which must have been completed at least 1 day 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 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 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. 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) =\< 2.5 × institutional ULN. Participants with history of liver metastasis must have AST and ALT =\< 5 x ULN (within 28 days prior to sub-study...
- Participants must have a serum creatinine =\ = 30 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 must have a cystatin C test performed to obtain baseline value 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 a completed medical history and physical exam within 28 days prior to sub-study randomization
- 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 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 must not have cirrhosis at a level of Child-Pugh B (or worse) OR any degree of cirrhosis AND a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis
- Participants must not have grade \< 0 of peripheral edema within 28 days prior to sub-study randomization
- Participants must not have experienced any arterial thromboembolic events, including but not limited to transient ischemic attack or cerebrovascular accident within 6 months prior to sub-study randomization
- Participants must not have uncontrolled blood pressure and hypertension within 28 days prior to sub-study randomization
- 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 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
- Daphne, Alabama, United States
- Fairhope, Alabama, United States
- Mobile, Alabama, United States
- Saraland, Alabama, United States
- Jonesboro, Arkansas, United States
- Little Rock, Arkansas, United States
- Anaheim, 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
- Fontana, California, United States
- Fremont, California, United States
- Harbor City, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Modesto, California, United States
- Ontario, California, United States
+ 205 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 minutes 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; Jonesboro, Arkansas, United States; Little Rock, Arkansas, United States and 219 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.