A Randomized Phase II Study of INC280 (Capmatinib) Plus Osimertinib With or Without Ramucirumab in Participants With EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)

Status: Recruiting
Location: See all (73) locations...
Intervention Type: Procedure, Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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. They work by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells and may help shrink tumors. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving capmatinib, osimertinib, and/or ramucirumab and targeting abnormal gene changes in tumor cells may be effective in shrinking or stabilizing advanced non-small cell lung cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 (Lung-Map)

• 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 other agent(s), as their most recent line of therapy. Any number of prior lines of therapy is allowed

• 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 submitted for testing by Foundation Medicine Inc (FMI) through the LUNGMAP screening protocol or using test results completed outside of the study. Tissue or blood must be obtained after disease progression on osimertinib (alone or in combination with another agent\[s\]). The testing must be done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO)/Independent Ethics Committee (IEC), College of American Pathologists (CAP), or similar certification

⁃ 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 screening protocol, if available

• 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. Measurable disease must be assessed within 28 days prior to sub-study randomization. Non-measurable disease must be assessed within 42 days prior to sub-study randomization. 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 randomization to be considered measurable

• 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 randomization

• 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 bilirubin =\< 5 x institutional ULN

• 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 =\< the IULN OR calculated creatinine clearance \>= 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 the QTcF intervals

• 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 =\< 1+ on dipstick or routine urinalysis (UA). Random analysis of urine protein with a normal value is sufficient. If urine dipstick or routine analysis indicated proteinuria \>= 2+, then a 24-hour urine is to be collected and demonstrate \< 2000 mg of protein in 24 hours to allow participation in the study

• 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 randomization. Participants must have a partial thromboplastin time (PTT) =\< 5 seconds above the 'institutional upper limit of normal (IULN) (unless receiving anticoagulation therapy) documented within 28 days prior to sub-study randomization

• 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 pancreatitis or pancreatic injury (e.g. elevated P. amylase, abnormal imaging findings of pancreas, etc.)

• 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 function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better

• 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 entered in the 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

• 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 events to the investigator). For 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

Locations
United States
Arizona
Cancer Center at Saint Joseph's
SUSPENDED
Phoenix
California
Mission Hope Medical Oncology - Arroyo Grande
SUSPENDED
Arroyo Grande
Mercy Cancer Center �� Carmichael
SUSPENDED
Carmichael
Mercy San Juan Medical Center
SUSPENDED
Carmichael
Mercy Cancer Center - Elk Grove
SUSPENDED
Elk Grove
Memorial Medical Center
RECRUITING
Modesto
Palo Alto Medical Foundation Health Care
RECRUITING
Palo Alto
Mercy Cancer Center - Rocklin
SUSPENDED
Rocklin
Mercy Cancer Center - Sacramento
SUSPENDED
Sacramento
Pacific Central Coast Health Center-San Luis Obispo
SUSPENDED
San Luis Obispo
Mission Hope Medical Oncology - Santa Maria
SUSPENDED
Santa Maria
Palo Alto Medical Foundation-Sunnyvale
RECRUITING
Sunnyvale
Woodland Memorial Hospital
SUSPENDED
Woodland
Colorado
Penrose-Saint Francis Healthcare
SUSPENDED
Colorado Springs
Rocky Mountain Cancer Centers-Penrose
SUSPENDED
Colorado Springs
Saint Francis Cancer Center
SUSPENDED
Colorado Springs
Porter Adventist Hospital
SUSPENDED
Denver
Mercy Medical Center
SUSPENDED
Durango
Southwest Oncology PC
SUSPENDED
Durango
Saint Anthony Hospital
SUSPENDED
Lakewood
Littleton Adventist Hospital
SUSPENDED
Littleton
Longmont United Hospital
SUSPENDED
Longmont
Parker Adventist Hospital
SUSPENDED
Parker
Saint Mary Corwin Medical Center
SUSPENDED
Pueblo
Georgia
Northeast Georgia Medical Center-Gainesville
RECRUITING
Gainesville
Iowa
Alegent Health Mercy Hospital
SUSPENDED
Council Bluffs
Illinois
Illinois CancerCare-Bloomington
RECRUITING
Bloomington
Illinois CancerCare-Canton
RECRUITING
Canton
Illinois CancerCare-Carthage
RECRUITING
Carthage
Cancer Care Specialists of Illinois - Decatur
RECRUITING
Decatur
Decatur Memorial Hospital
RECRUITING
Decatur
Illinois CancerCare-Dixon
RECRUITING
Dixon
Crossroads Cancer Center
RECRUITING
Effingham
Illinois CancerCare-Eureka
RECRUITING
Eureka
Illinois CancerCare-Galesburg
RECRUITING
Galesburg
Illinois CancerCare-Kewanee Clinic
RECRUITING
Kewanee
Illinois CancerCare-Macomb
RECRUITING
Macomb
Illinois CancerCare-Ottawa Clinic
RECRUITING
Ottawa
Illinois CancerCare-Pekin
RECRUITING
Pekin
Illinois CancerCare-Peoria
RECRUITING
Peoria
Illinois CancerCare-Peru
RECRUITING
Peru
Illinois CancerCare-Princeton
RECRUITING
Princeton
Southern Illinois University School of Medicine
RECRUITING
Springfield
Illinois CancerCare - Washington
RECRUITING
Washington
Kentucky
Flaget Memorial Hospital
SUSPENDED
Bardstown
Commonwealth Cancer Center-Corbin
SUSPENDED
Corbin
Saint Joseph Hospital
SUSPENDED
Lexington
Saint Joseph Hospital East
SUSPENDED
Lexington
Saint Joseph Radiation Oncology Resource Center
SUSPENDED
Lexington
Saint Joseph London
SUSPENDED
London
Saint Joseph Mount Sterling
SUSPENDED
Mount Sterling
Maine
Lafayette Family Cancer Center-EMMC
RECRUITING
Brewer
Missouri
Saint Francis Medical Center
RECRUITING
Cape Girardeau
Nebraska
CHI Health Good Samaritan
SUSPENDED
Kearney
Saint Elizabeth Regional Medical Center
SUSPENDED
Lincoln
Alegent Health Bergan Mercy Medical Center
SUSPENDED
Omaha
Alegent Health Immanuel Medical Center
SUSPENDED
Omaha
Alegent Health Lakeside Hospital
SUSPENDED
Omaha
Creighton University Medical Center
SUSPENDED
Omaha
Midlands Community Hospital
SUSPENDED
Papillion
New Jersey
Virtua Samson Cancer Center
RECRUITING
Moorestown
Virtua Voorhees
RECRUITING
Voorhees Township
Ohio
Bethesda North Hospital
SUSPENDED
Cincinnati
Good Samaritan Hospital - Cincinnati
SUSPENDED
Cincinnati
TriHealth Cancer Institute-Anderson
SUSPENDED
Cincinnati
TriHealth Cancer Institute-Westside
SUSPENDED
Cincinnati
ProMedica Flower Hospital
RECRUITING
Sylvania
Wisconsin
Langlade Hospital and Cancer Center
RECRUITING
Antigo
Aspirus Medford Hospital
RECRUITING
Medford
Ascension Saint Mary's Hospital
RECRUITING
Rhinelander
Ascension Saint Michael's Hospital
RECRUITING
Stevens Point
Aspirus Regional Cancer Center
RECRUITING
Wausau
Aspirus Cancer Care - Wisconsin Rapids
RECRUITING
Wisconsin Rapids
Time Frame
Start Date: 2023-05-05
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 66
Treatments
Experimental: Arm A (capmatinib, osimertinib, ramucirumab)
Patients receive capmatinib PO, osimertinib PO, and ramucirumab IV on study. Patients also undergo CT scan or MRI and collection of blood samples throughout the trial.
Experimental: Arm B (capmatinib, osimertinib)
Patients receive capmatinib PO and osimertinib PO on study. Patients also undergo CT scan or MRI and collection of blood samples throughout the trial.
Sponsors
Leads: SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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