AZD9291 for Non-Small Cell Lung Cancer (ADAURA Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

Stay on your current meds

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy

Eligibility Criteria

This trial is for adults over 18 with Stage IB-IIIA non-small cell lung cancer that's been surgically removed. They must have specific EGFR mutations, no major organ issues, and can't be on certain drugs or have had certain treatments. Women must not be pregnant and use birth control.

Inclusion Criteria

My lung cancer is confirmed to be non-small cell and mostly not squamous.

My cancer was classified as Stage IB, II, or IIIA after surgery.

My tumor has EGFR mutations sensitive to treatment.

I can perform most of my daily activities without help.

My lung cancer was completely removed by surgery with no cancer cells at the edges.

Exclusion Criteria

I do not have severe illnesses, uncontrolled high blood pressure, active bleeding, or infections like hepatitis or HIV.

I am receiving or have received chemotherapy before surgery.

I am scheduled for, or have had, radiation therapy for my lung cancer.

I haven't had major surgery, except for a vascular access procedure, in the last 4 weeks.

I am not taking any strong CYP3A4 inducers.

I have had a small part of my lung removed.

I have had lung inflammation or damage that needed steroids.

I cannot take pills due to severe nausea, vomiting, gut diseases, or major gut surgery.

I have been treated with EGFR-TKI drugs before surgery or alongside other treatments.

My bone marrow or organs are not functioning well.

I have received treatment for cancer before.

Treatment Details

The trial tests the effectiveness of AZD9291 (a targeted cancer drug) against a placebo in patients who've had surgery for lung cancer. Some may also receive standard chemotherapy. The goal is to see if AZD9291 improves outcomes post-surgery.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AZD9291Experimental Treatment2 Interventions

AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.

Group II: Placebo AZD9291Placebo Group1 Intervention

Matching placebo for AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.