AZD9291 Combinations for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+33 other locations

Overseen byPasi A Jänne, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to determine the safety, tolerability and preliminary anti-tumour activity of AZD9291 when given together with AZD6094 or selumetinib in patients with EGFR mutation positive advanced lung cancer

Eligibility Criteria

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

My lung cancer has a specific EGFR mutation.

Signed informed consent

I am 18 years old or older.

+10 more

Exclusion Criteria

I do not have stomach or intestine problems affecting medication absorption.

I am not taking any strong CYP3A4 inducers for the last 3 weeks.

I have previously been treated with a specific type of lung cancer medication.

+19 more

Participant Groups

The trial is testing the safety and effectiveness of AZD9291 in combination with other drugs (AZD6094 or selumetinib) for treating advanced lung cancer. It's exploring different combinations to see which works best against tumors that have a particular mutation making them resistant to standard treatments.

4Treatment groups

Experimental Treatment

Group I: SelumetinibExperimental Treatment4 Interventions

AZD9291 in combination with selumetinib

Group II: MEDI4736Experimental Treatment2 Interventions

AZD9291 in combination with MEDI4736. Enrolment into the patient cohort that evaluated AZD9291 treatment in combination with MEDI4736 as 1st line treatment has been terminated due to an increased incidence of ILD-like events (interstitial lung disease/pneumonitis), and is no longer being evaluated in this study.

Group III: AZD6094 (monotherapy)Experimental Treatment1 Intervention

AZD6094 in monotherapy (for Japan only)

Group IV: AZD6094Experimental Treatment4 Interventions

AZD9291 in combination with AZD6094