Osimertinib + Chemotherapy for Lung Cancer
(NeoADAURA Trial)

Recruiting in Palo Alto (17 mi)

+145 other locations

Overseen byJamie E Chaft, MD

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

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing osimertinib, a drug that targets cancer cells, either by itself or with chemotherapy. It focuses on patients with a specific type of lung cancer that has a mutation in the EGFR gene. The drug works by stopping the growth of cancer cells.

Eligibility Criteria

This trial is for adults with a specific type of lung cancer (non-squamous NSCLC) that can be surgically removed. Patients must have certain EGFR mutations, good performance status, and no history of severe lung conditions or other cancers within the last 2 years. Prior cancer treatments for NSCLC are not allowed.

Inclusion Criteria

My non-squamous NSCLC is at stage II - IIIB N2 and can be completely removed with surgery.

I can care for myself and perform light activities without help.

I am 18 years old or older.

+3 more

Exclusion Criteria

I have had lung inflammation or damage that needed steroids.

My lung cancer is a mix of small cell and non-small cell types.

I am not using, nor can I stop using, certain medications or supplements that affect my liver enzymes.

+7 more

Participant Groups

The study tests Osimertinib alone or combined with chemotherapy against standard-of-care chemotherapy in patients who can undergo surgery to remove their lung cancer. It's a Phase III trial where participants are randomly assigned to one of three groups.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 3: Osimertinib monotherapyExperimental Treatment1 Intervention

Osimertinib 80 mg QD (Dose may be reduced to 40 mg QD at the discretion of the investigator)

Group II: Arm 2: Osimertinib with platinum-based chemotherapyExperimental Treatment4 Interventions

Osimertinib 80 mg QD (Dose may be reduced to 40 mg QD at the discretion of the investigator) plus investigator's choice of platinum-based standard of care chemotherapy (pemetrexed/carboplatin or pemetrexed/cisplatin)

Group III: Arm 1: Placebo with platinum-based chemotherapyPlacebo Group4 Interventions

Placebo plus investigator's choice of platinum-based standard of care chemotherapy (pemetrexed/carboplatin or pemetrexed/cisplatin)

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: