🏛️ Verified NIH Record • Updated 2025-12-04

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) (NCT04625647)

A Phase II Study of AMG 510 in Participants With Previously Treated Stage IV or Recurrent KRAS G12C Mutated Non-Squamous Non-Small Cell Lung Cancer (ECOG-ACRIN LUNG-MAP SUB-STUDY)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: SWOG Cancer Research Network

🩺 Plain-English Summary (8th-Grade Level)

This phase II Lung-MAP treatment trial studies the effect of AMG 510 in treating non-squamous non-small cell lung cancer that is stage IV or has come back (recurrent) and has a specific mutation in the KRAS gene, known as KRAS G12C. Mutations in this gene may cause the cancer to grow. AMG 510, a targeted treatment against the KRAS G12C mutation, may help stop the growth of tumor cells.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (26 items) and avoid the listed exclusions (14 items).

Location: Veterans Administration Medical Center - Birmingham — Birmingham, Alabama

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (829 Sites)

Showing the first 25 of 829 sites.

  • Veterans Administration Medical Center - Birmingham — Birmingham, Alabama
  • Anchorage Associates in Radiation Medicine — Anchorage, Alaska
  • Anchorage Radiation Therapy Center — Anchorage, Alaska
  • Alaska Breast Care and Surgery LLC — Anchorage, Alaska
  • Alaska Oncology and Hematology LLC — Anchorage, Alaska
  • Alaska Women's Cancer Care — Anchorage, Alaska
  • Anchorage Oncology Centre — Anchorage, Alaska
  • Katmai Oncology Group — Anchorage, Alaska
  • Providence Alaska Medical Center — Anchorage, Alaska
  • Fairbanks Memorial Hospital — Fairbanks, Alaska
  • Kingman Regional Medical Center — Kingman, Arizona
  • Cancer Center at Saint Joseph's — Phoenix, Arizona
  • Banner University Medical Center - Tucson — Tucson, Arizona
  • University of Arizona Cancer Center-North Campus — Tucson, Arizona
  • Mercy Hospital Fort Smith — Fort Smith, Arkansas
  • CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas
  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas
  • University of Arkansas for Medical Sciences — Little Rock, Arkansas
  • Kaiser Permanente-Anaheim — Anaheim, California
  • Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California
  • PCR Oncology — Arroyo Grande, California
  • Sutter Auburn Faith Hospital — Auburn, California
  • Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California
  • Kaiser Permanente-Baldwin Park — Baldwin Park, California
  • Kaiser Permanente-Bellflower — Bellflower, California

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗