RECRUITING

Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Trial)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2023-05-05
Study Completion:2027-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05642572

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * 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
  3. * 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
  4. * 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
  5. * 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
  6. * 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
  7. * 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
  8. * 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
  9. * Participants must have recovered (=\< grade 1) from any side effects of prior therapy, except for alopecia and vitiligo
  10. * Participants must be able to swallow tablets whole
  11. * Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to sub-study randomization)
  12. * Hemoglobin \< 9.0 g/dL (within 28 days prior to sub-study randomization)
  13. * Platelets \>= 100 x 10\^3/uL (within 28 days prior to sub-study randomization)
  14. * 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
  15. * 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)
  16. * 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
  17. * Participants' most recent Zubrod performance status must be 0-1 and be documented within 28 days prior to sub-study randomization
  18. * 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
  19. * Participants must have a completed medical history and physical exam within 28 days prior to sub-study randomization
  20. * 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
  21. * 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
  22. * 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
  23. * 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.)
  24. * 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
  25. * Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)
  26. * Participants must also be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System
  27. * 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
  28. * 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
  29. * 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
  1. * Participants must not have received an anti-VEGF or VEGFR inhibitor or MET inhibitor
  2. * 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
  3. * Note: osimertinib may continue up to the day prior to study treatment initiation
  4. * Participants must not have received any radiation therapy within 14 days prior to sub-study randomization
  5. * Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study
  6. * 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
  7. * 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 use authorization are acceptable
  8. * 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 MATE2K; or drugs that are known to prolong QT interval within 7 days prior to sub-study registration and must not be planning to use any of these throughout protocol treatment
  9. * Participants must not have uncontrolled blood pressure and hypertension within 28 days prior to sub-study randomization
  10. * 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
  11. * 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

Contacts and Locations

Principal Investigator

Sarah B Goldberg
PRINCIPAL_INVESTIGATOR
SWOG Cancer Research Network

Study Locations (Sites)

Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004
United States
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
United States
Mercy Cancer Center �� Carmichael
Carmichael, California, 95608
United States
Mercy San Juan Medical Center
Carmichael, California, 95608
United States
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758
United States
Memorial Medical Center
Modesto, California, 95355
United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301
United States
Mercy Cancer Center - Rocklin
Rocklin, California, 95765
United States
Mercy Cancer Center - Sacramento
Sacramento, California, 95816
United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, 93401
United States
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, 93444
United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, 94086
United States
Woodland Memorial Hospital
Woodland, California, 95695
United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
United States
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923
United States
Porter Adventist Hospital
Denver, Colorado, 80210
United States
Mercy Medical Center
Durango, Colorado, 81301
United States
Southwest Oncology PC
Durango, Colorado, 81301
United States
Saint Anthony Hospital
Lakewood, Colorado, 80228
United States
Littleton Adventist Hospital
Littleton, Colorado, 80122
United States
Longmont United Hospital
Longmont, Colorado, 80501
United States
Parker Adventist Hospital
Parker, Colorado, 80138
United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004
United States
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501
United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
United States
Illinois CancerCare-Canton
Canton, Illinois, 61520
United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
United States
Crossroads Cancer Center
Effingham, Illinois, 62401
United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
United States
Illinois CancerCare-Peru
Peru, Illinois, 61354
United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Illinois CancerCare - Washington
Washington, Illinois, 61571
United States
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
United States
Flaget Memorial Hospital
Bardstown, Kentucky, 40004
United States
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
United States
Saint Joseph Hospital
Lexington, Kentucky, 40504
United States
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, 40504
United States
Saint Joseph Hospital East
Lexington, Kentucky, 40509
United States
Saint Joseph London
London, Kentucky, 40741
United States
Saint Joseph Mount Sterling
Mount Sterling, Kentucky, 40353
United States
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412
United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
United States
CHI Health Good Samaritan
Kearney, Nebraska, 68847
United States
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510
United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122
United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124
United States
Alegent Health Lakeside Hospital
Omaha, Nebraska, 68130
United States
Creighton University Medical Center
Omaha, Nebraska, 68131
United States
Midlands Community Hospital
Papillion, Nebraska, 68046
United States
Virtua Samson Cancer Center
Moorestown, New Jersey, 08057
United States
Virtua Voorhees
Voorhees, New Jersey, 08043
United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
United States
Bethesda North Hospital
Cincinnati, Ohio, 45242
United States
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
United States
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560
United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409
United States
Aspirus Medford Hospital
Medford, Wisconsin, 54451
United States
Ascension Saint Mary's Hospital
Rhinelander, Wisconsin, 54501
United States
Ascension Saint Michael's Hospital
Stevens Point, Wisconsin, 54481
United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401
United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494
United States

Collaborators and Investigators

Sponsor: SWOG Cancer Research Network

  • Sarah B Goldberg, PRINCIPAL_INVESTIGATOR, SWOG Cancer Research Network

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-05
Study Completion Date2027-05-31

Study Record Updates

Study Start Date2023-05-05
Study Completion Date2027-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Recurrent Lung Non-Small Cell Carcinoma
  • Stage IV Lung Cancer AJCC v8