Chemotherapy + Osimertinib for Non-Small Cell Lung Cancer
(COMPEL Trial)
Trial Summary
What is the purpose of this trial?
This trial tests a combination of chemotherapy and osimertinib in patients with advanced lung cancer that has spread outside the brain after earlier treatment. Osimertinib blocks a protein that helps cancer grow, and chemotherapy kills cancer cells. Osimertinib has shown improvements in progression-free survival over earlier treatments and is preferred for initial treatment of EGFR-mutant NSCLC.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but it does exclude those using medications or supplements that strongly affect a specific liver enzyme (CYP3A4). It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug combination of chemotherapy and osimertinib for non-small cell lung cancer?
Osimertinib has shown effectiveness in treating non-small cell lung cancer (NSCLC) with specific genetic mutations, significantly prolonging progression-free survival and demonstrating durable tumor response rates in clinical trials. It is particularly effective for patients with EGFR T790M mutation-positive NSCLC who have developed resistance to earlier treatments.12345
Is the combination of chemotherapy and osimertinib safe for humans?
Osimertinib, also known as Tagrisso, has been studied for safety in patients with non-small cell lung cancer. Common side effects include diarrhea, rash, dry skin, and nail issues, with some patients experiencing more severe side effects. It is generally well tolerated, but some patients may need to stop treatment due to side effects.12346
How does the drug combination of Chemotherapy and Osimertinib differ from other drugs for non-small cell lung cancer?
The combination of Chemotherapy and Osimertinib is unique because it pairs traditional chemotherapy, which kills rapidly dividing cancer cells, with Osimertinib, a targeted therapy that specifically inhibits a protein involved in cancer cell growth. This dual approach aims to enhance treatment effectiveness by attacking the cancer in two different ways.7891011
Eligibility Criteria
This trial is for adults with advanced or metastatic non-squamous NSCLC who've seen their cancer progress after first-line osimertinib treatment. They should be in good physical condition, not planning to have surgery or radiotherapy, and willing to use effective contraception. People can't join if they've had certain treatments recently, have heart rhythm problems, severe diseases, another active cancer within 2 years, lung conditions like ILD/pneumonitis, or can't absorb the drug well.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive platinum plus pemetrexed chemotherapy with either osimertinib or placebo for 4 cycles, followed by maintenance therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Chemotherapy
- Osimertinib
Chemotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Breast cancer
- Metastatic breast cancer
- Various other cancers
- Breast cancer
- Metastatic breast cancer
- Various other cancers
- Breast cancer
- Metastatic breast cancer
- Various other cancers
- Breast cancer
- Metastatic breast cancer
- Various other cancers
- Breast cancer
- Metastatic breast cancer
- Various other cancers
- Breast cancer
- Metastatic breast cancer
- Various other cancers
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Parexel
Industry Sponsor
Peyton Howell
Parexel
Chief Executive Officer
Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois
Dr. Austin Smith
Parexel
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland