Testing the Use of Targeted Treatment (AMG 510) for KRAS G12C Mutated Advanced Non-squamous Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)
Launched by SWOG CANCER RESEARCH NETWORK · Nov 6, 2020
Trial Information
Current as of April 30, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a treatment called AMG 510 for patients with advanced non-small cell lung cancer (NSCLC) that has a specific mutation in the KRAS gene, known as KRAS G12C. This mutation can make the cancer grow more aggressively, and AMG 510 is designed to target and potentially stop the growth of cancer cells with this mutation. The trial is open to adults aged 65 and older who have stage IV or recurrent non-squamous NSCLC and have already tried at least one other treatment for their cancer.
If you qualify and choose to participate, you will receive AMG 510 and be closely monitored by the research team. They will assess your condition through imaging tests to see how well the treatment is working. It’s important to know that you must meet certain health criteria, such as having measurable disease and having recovered from any side effects of previous treatments. Participation involves regular check-ups and tests, and you’ll be part of a study that aims to improve treatment options for people with this specific type of lung cancer.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Participants must be assigned to S1900E. Assignment to S1900E is determined by the LUNGMAP protocol genomic profiling using the FoundationOne assay. Biomarker eligibility for S1900E is based on the identification of a KRAS\^G12C mutation
- • Participants must have confirmed stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC). Mixed histology NSCLC with less than 50% squamous component is allowed
- • Participants must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI). The CT from a combined positron emission tomography (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 registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to sub-study registration. 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 registration
- • 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 known human immunodeficiency virus (HIV) infection must be receiving anti-retroviral therapy and have an undetectable viral load at their most recent viral load test within 6 months prior to sub-study registration
- • Participants with EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS1 gene rearrangement, or BRAF V600E mutation must have progressed following all standard of care targeted therapy
- • Participants with spinal cord compression or brain metastases must have received local treatment to these metastases and remained clinically controlled and asymptomatic for at least 7 days following stereotactic radiation and/or 14 days following whole brain radiation, and prior to sub-study registration
- • Participants must have received at least one line of systemic treatment for stage IV or recurrent NSCLC
- • Participants must have progressed (in the opinion of the treating physician) following the most recent line of systemic therapy for NSCLC
- • Participants must have recovered (=\< grade 1) from 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 (i.e., endocrinopathy from immunotherapy or cisplatin neurotoxicity)
- • Participants must be able to swallow tablets whole
- • Pre-study history and physical exam must be obtained within 28 days prior to sub-study registration
- • Absolute neutrophil count (ANC) \>= 1,500/uL obtained within 28 days prior to sub-study registration
- • Platelet count \>= 75,000/uL obtained within 28 days prior to sub-study registration
- • Hemoglobin \>= 9 g/dL obtained within 28 days prior to sub-study registration
- • Serum bilirubin =\< institutional upper limit of normal (IULN) within 28 days prior to sub-study registration
- • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2 x IULN within 28 days prior to sub-study registration. For participants with liver metastases, and ALT and AST must be =\< 5 x IULN
- • Participants must have a serum creatinine =\< 1.5 x 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 registration
- • Participants must have Zubrod performance status 0-1 documented within 28 days prior to sub-study registration
- • Participants of reproductive potential must have a negative serum pregnancy test within 28 days prior to sub-study registration
- • Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)
- • Participants must be offered the opportunity to participate in specimen banking and in correlative studies for collection and future use of specimens. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (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: As a part of the Oncology Patient Enrollment Network (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
- • As a part of the Oncology Patient Enrollment Network (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 with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude 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
- Exclusion Criteria:
- • Participants with spinal cord compression or brain metastases must not have residual neurological dysfunction, unless no further recovery is expected, and the participant has been stable on weaning doses of corticosteroids prior to sub-study registration
- • Participants must not have leptomeningeal disease unless: (1) asymptomatic and (2) only detected on radiographic imaging (i.e., not present in cytology from cerebral spinal fluid \[CSF\] if CSF sampled)
- • 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 received any radiation therapy within 14 days prior to sub-study registration, with the exception of stereotactic radiation to CNS metastases which must have been completed at least 7 days prior to sub-study registration
- • Participants must not have received prior AMG 510 or other KRAS\^G12C specific inhibitor
- • 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 registration. Participant must have fully recovered from the effects of prior surgery in the opinion of the treating investigator
- • Participants must not have any grade III/IV cardiac disease as defined by the New York Heart Association criteria (i.e., participants with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
- • Participants must not have a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
- • Participants must not have gastrointestinal disorders that may impact drug absorption
- • Participants must not have received strong inducers of CYP3A4 (including herbal supplements such as St. John's wort) within 14 days prior to sub-study registration and must not be planning to use strong inducers of CYP3A4 throughout protocol treatment
- • Participants must not have received CYP3A4 sensitive substrates (with a narrow therapeutic window) within 14 days prior to sub-study registration and must not be planning to use CYP3A4 sensitive substrates (with a narrow therapeutic window) throughout protocol treatment
- • Participants must not be pregnant or nursing. Participants with uteri must have agreed to use an effective contraceptive method for at least one month after the last dose of AMG 510. Participants with sperm must have agreed to use an effective contraceptive method for at least 3 months after the last dose of AMG 510. Participants are considered to be of "reproductive potential" if they have had menses at any time in the preceding 12 consecutive months and no prior oophorectomy and/or hysterectomy. In addition to routine contraceptive methods, "effective contraception" for participants with uteri also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. Acceptable methods of birth control for participants with sperm include sexual abstinence (refraining from heterosexual intercourse); vasectomy with testing showing there is no sperm in the semen; bilateral tubal ligation or occlusion in the partner; or a condom (the female partner should also consider a form of birth control). However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
About Swog Cancer Research Network
The SWOG Cancer Research Network is a leading cancer clinical trial organization dedicated to improving cancer treatment and outcomes through innovative research. Comprising a collaborative network of academic institutions, community hospitals, and cancer centers, SWOG conducts rigorous clinical trials that advance the understanding of cancer biology, prevention, and therapy. With a strong emphasis on inclusivity and diversity, SWOG aims to ensure that clinical research reflects the populations affected by cancer, ultimately striving to enhance patient care and quality of life. Through its commitment to scientific excellence and collaboration, SWOG plays a pivotal role in shaping the future of oncology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lebanon, New Hampshire, United States
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'Aiea, Hawaii, United States
Kenner, Louisiana, United States
'Aiea, Hawaii, United States
Carlisle, Pennsylvania, United States
Ontario, California, United States
Ashland, Wisconsin, United States
Gahanna, Ohio, United States
Chambersburg, Pennsylvania, United States
White River Junction, Vermont, United States
Midlothian, Virginia, United States
Phoenix, Arizona, United States
San Luis Obispo, California, United States
Santa Maria, California, United States
Boulder, Colorado, United States
Tawas City, Michigan, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Moorestown, New Jersey, United States
Rio Rancho, New Mexico, United States
Perrysburg, Ohio, United States
Brewer, Maine, United States
Warrensville Heights, Ohio, United States
Milford, Delaware, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Pahrump, Nevada, United States
Beavercreek, Ohio, United States
Arroyo Grande, California, United States
West Haven, Connecticut, United States
Baton Rouge, Louisiana, United States
Aitkin, Minnesota, United States
Deer River, Minnesota, United States
Hibbing, Minnesota, United States
Sandstone, Minnesota, United States
Virginia, Minnesota, United States
Hazleton, Pennsylvania, United States
Collierville, Tennessee, United States
Ashland, Wisconsin, United States
Medford, Wisconsin, United States
Norfolk, Virginia, United States
Honolulu, Hawaii, United States
Ballwin, Missouri, United States
Washington, Missouri, United States
Denver, Colorado, United States
Mooresville, Indiana, United States
Worthington, Minnesota, United States
Redmond, Oregon, United States
Mechanicsville, Virginia, United States
Wauwatosa, Wisconsin, United States
Braselton, Georgia, United States
'Aiea, Hawaii, United States
Detroit Lakes, Minnesota, United States
Fosston, Minnesota, United States
Park Rapids, Minnesota, United States
Jamestown, North Dakota, United States
Birmingham, Alabama, United States
Tampa, Florida, United States
Fargo, North Dakota, United States
Chadds Ford, Pennsylvania, United States
Kingman, Arizona, United States
Centennial, Colorado, United States
Denver, Colorado, United States
Englewood, Colorado, United States
Dixon, Illinois, United States
Washington, Illinois, United States
Farmington, Missouri, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
San Mateo, California, United States
Englewood, Colorado, United States
Frankford, Delaware, United States
Tampa, Florida, United States
Peabody, Massachusetts, United States
Burnsville, Minnesota, United States
York, Pennsylvania, United States
Richmond, Virginia, United States
Chilton, Wisconsin, United States
Franklin, Wisconsin, United States
Alliance, Ohio, United States
Duluth, Georgia, United States
Snellville, Georgia, United States
Silvis, Illinois, United States
Davenport, Iowa, United States
Cambridge, Minnesota, United States
Princeton, Minnesota, United States
'Ewa Beach, Hawaii, United States
Honolulu, Hawaii, United States
Kahului, Hawaii, United States
Thief River Falls, Minnesota, United States
East Hills, New York, United States
Camp Hill, Pennsylvania, United States
East Norriton, Pennsylvania, United States
Midlothian, Virginia, United States
Cudahy, Wisconsin, United States
Milwaukee, Wisconsin, United States
Tamuning, , Guam
Princeton, Minnesota, United States
Torrance, California, United States
Charleston, South Carolina, United States
Fargo, North Dakota, United States
Fargo, North Dakota, United States
Portsmouth, Virginia, United States
Suffolk, Virginia, United States
Weston, Florida, United States
Patients applied
Trial Officials
Sukhmani K Padda
Principal Investigator
SWOG Cancer Research Network
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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