Sotorasib for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must not have received any systemic therapy, including chemotherapy or immunotherapy, within 21 days before joining the trial. Also, you cannot use strong inducers of CYP3A4 or CYP3A4 sensitive substrates within 14 days before and during the trial. It's best to discuss your current medications with the trial team.
Do I need to stop taking my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but you must not have received any systemic therapy within 21 days before joining. Additionally, you cannot use strong inducers of CYP3A4 or CYP3A4 sensitive substrates within 14 days before and during the trial.
What safety data is available for Sotorasib in treating non-small cell lung cancer?
Sotorasib, also known as Lumakras, has been evaluated for safety in treating KRAS G12C-mutated non-small cell lung cancer (NSCLC). The FDA granted accelerated approval based on the CodeBreaK 100 trial, which showed an overall response rate of 36% in patients. Common adverse reactions (≥20%) included diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough. Sotorasib has a manageable tolerability profile, with dose modifications allowed to manage toxicity.12345
Is Sotorasib safe for humans?
Is the drug Sotorasib a promising treatment for non-small cell lung cancer?
Yes, Sotorasib is a promising drug for non-small cell lung cancer. It has shown positive results in clinical trials, helping patients with a specific genetic mutation (KRAS G12C) in their cancer. It has been approved for use in the USA and Europe, offering new hope for patients who have already tried other treatments.34567
What makes the drug Sotorasib unique for treating non-small cell lung cancer?
Sotorasib is unique because it is the first drug specifically targeting the KRAS G12C mutation, a common mutation in non-small cell lung cancer, and it works by blocking signals that promote cancer cell growth. It is taken orally and has shown promising results in patients who have already received other treatments.34567
What data supports the idea that Sotorasib for Non-Small Cell Lung Cancer is an effective drug?
The available research shows that Sotorasib is effective for treating non-small cell lung cancer with a specific mutation called KRAS G12C. It was granted accelerated approval by the US FDA for patients who have already tried other treatments. Studies have shown that Sotorasib has promising anticancer activity, especially in patients with this type of lung cancer. In clinical trials, patients experienced a significant response to the drug, meaning their cancer showed signs of shrinking or stopping growth. This makes Sotorasib a promising option for those who have not had success with other treatments.13456
What data supports the effectiveness of the drug Sotorasib for treating non-small cell lung cancer?
Sotorasib has shown promising results in treating non-small cell lung cancer (NSCLC) with a specific KRAS mutation, as it was approved by the FDA for patients who have already tried other treatments. Studies have shown that it can effectively target and inhibit the growth of cancer cells in patients with this mutation.13456
Who Is on the Research Team?
Sukhmani Padda, MD
Principal Investigator
SWOG Cancer Research Network
Are You a Good Fit for This Trial?
This trial is for adults with advanced non-squamous non-small cell lung cancer that has a specific KRAS G12C mutation and has worsened after treatment. They must have had at least one systemic therapy, be able to swallow pills, not be pregnant or nursing, and agree to use contraception if applicable. People with certain heart conditions, other cancers, or those who can't take the study drug due to interactions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AMG 510 orally once daily on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Follow-up occurs every 3 months for 3 years if the disease has not progressed, or every 6 months for 2 years if the disease has progressed.
What Are the Treatments Tested in This Trial?
Interventions
- Sotorasib
Sotorasib is already approved in United States, European Union for the following indications:
- KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)
- KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Southwest Oncology Group
Lead Sponsor
SWOG Cancer Research Network
Lead Sponsor
National Cancer Institute (NCI)
Collaborator