AZD9291 Combinations for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and initial effectiveness of combining AZD9291, a targeted therapy, with either AZD6094 or selumetinib for advanced lung cancer. It targets individuals with non-small cell lung cancer (NSCLC) who have a specific EGFR mutation and whose condition has worsened despite previous treatment. Participants must have an EGFR mutation responsive to certain treatments and must have experienced disease progression on previous EGFR therapies like gefitinib or erlotinib. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial requires stopping certain medications before starting the study. You must stop taking EGFR TKIs (like erlotinib or gefitinib) about 8 days before the first dose and avoid certain other medications and supplements that affect liver enzymes at least 3 weeks prior.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have generally found AZD9291 (osimertinib) to be safe and well-tolerated. Research suggests that combining it with AZD6094 (savolitinib) is safe for patients with certain types of lung cancer. Other studies have shown that AZD6094, often used with other drugs, is safe on its own.
For the combination of AZD9291 and selumetinib, early findings suggest it is likely safe, though more research is needed to confirm this. Selumetinib has been tested in various cancer treatments and is generally considered safe when used correctly.
However, a significant safety concern arises with AZD9291 when combined with MEDI4736. This combination previously led to more cases of interstitial lung disease (a condition affecting lung tissue) and pneumonitis (lung inflammation). Due to these safety concerns, this combination is no longer under study.
Overall, while some combinations show promising safety results, the AZD9291 and MEDI4736 pairing has shown notable risks and is no longer being researched. Participants should discuss potential risks with their healthcare provider before joining any trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about AZD9291 combinations for non-small cell lung cancer (NSCLC) because they offer a fresh approach to treatment compared to traditional therapies like chemotherapy and targeted therapies such as EGFR inhibitors. Unlike existing options, AZD9291 targets specific mutations in the EGFR gene, which are often responsible for resistance to first-line treatments. When combined with AZD6094 or selumetinib, AZD9291 may enhance the treatment's effectiveness by addressing different pathways involved in cancer growth. This multi-faceted attack on cancer cells has the potential to improve outcomes for patients who have limited options after initial therapies fail.
What evidence suggests that this trial's treatments could be effective for advanced lung cancer?
Research has shown that AZD9291, also known as osimertinib, holds promise for treating non-small cell lung cancer (NSCLC) with specific EGFR mutations. Studies have found that patients with certain resistant mutations experienced an average of 9.6 months before cancer progression. In this trial, researchers are testing AZD9291 in combination with selumetinib, which targets specific cancer cell pathways. Early lab tests indicate better cancer cell inhibition with this combination. Another arm of this trial involves AZD9291 combined with savolitinib (AZD6094), which targets a protein called MET, known to be overly active in some cancers. This combination has shown effectiveness in lung cancer. These findings suggest these treatments may be effective against certain advanced lung cancers.12367
Who Is on the Research Team?
Pasi A Jänne, MD, PhD
Principal Investigator
Dana-Faber Cancer Institute
Are You a Good Fit for This Trial?
Adults with advanced lung cancer and specific EGFR mutations who've seen their disease progress on previous EGFR TKI treatments like gefitinib or erlotinib. They must have at least one measurable lesion, be able to take oral meds, and have good organ function. Pregnant women, those with certain heart conditions or active infections, and patients recently on other cancer therapies are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Combination Dose Finding
Participants receive AZD9291 in combination with novel therapeutics to determine optimal dosing and schedule
Dose Expansion
Further evaluation of safety and tolerability of the determined combination dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD6094
- AZD9291
- Selumetinib
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