Multiple Therapies for Stage III Non-Small Cell Lung Cancer
Trial Summary
What is the purpose of this trial?
This trial is testing different treatments to see how well they work and how safe they are. It focuses on patients with advanced lung cancer that cannot be removed by surgery and have specific biological markers. The goal is to find out if these treatments can stop the cancer from growing or spreading and improve patients' health.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it does exclude participants who are on certain treatments like systemic immunosuppressive medications or concurrent cancer therapies, so it's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Durvalumab (Imfinzi) for treating stage III non-small cell lung cancer?
Research shows that Durvalumab, when used after chemoradiotherapy, significantly improves progression-free survival and overall survival in patients with stage III non-small cell lung cancer compared to a placebo. This suggests that Durvalumab can be an effective treatment option for this condition.12345
Is the treatment generally safe for humans?
Durvalumab, one of the treatments being considered, has been shown to increase the risk of immune-related side effects, particularly pneumonitis (inflammation of the lungs), which can be serious and potentially life-threatening. Safety data from various studies indicate that while durvalumab is used in treating certain cancers, it is important to monitor for these side effects.46789
How is the drug combination of Alectinib, Durvalumab, Entrectinib, and Pralsetinib unique for treating Stage III non-small cell lung cancer?
This drug combination is unique because it includes multiple targeted therapies and immunotherapy agents, such as Durvalumab, which has shown improved survival in patients with unresectable Stage III non-small cell lung cancer when used after chemoradiotherapy. The combination of these drugs may offer a novel approach by targeting different pathways involved in cancer growth and immune evasion.510111213
Research Team
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Eligibility Criteria
This trial is for adults with Stage III Non-Small Cell Lung Cancer (NSCLC) who can swallow pills, have had prior chemo and radiotherapy without disease progression, and are expected to live at least 12 weeks. They must not be pregnant or planning pregnancy, agree to use contraception, and have no history of certain bone disorders or severe allergies.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive entrectinib 600 mg orally once daily or durvalumab 1500 mg IV every 4 weeks, depending on cohort, until completion of treatment period or other specified conditions
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Alectinib
- Durvalumab
- Entrectinib
- Pralsetinib
Alectinib is already approved in United States, European Union for the following indications:
- Metastatic ALK-positive non-small cell lung cancer (NSCLC)
- Adjuvant treatment following tumor resection in patients with ALK-positive NSCLC
- Metastatic ALK-positive non-small cell lung cancer (NSCLC)
- Adjuvant treatment following tumor resection in patients with ALK-positive NSCLC
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University