ADAURA: What the Lung Cancer Trial Found

A pill after surgery, for one group of people

ADAURA asked a narrow question. If a lung cancer has been removed completely by surgery, and that cancer carries an EGFR mutation, does taking osimertinib afterward keep it from coming back?

The answer, published in the New England Journal of Medicine in 2020, was yes. A follow-up paper in 2023 showed people also lived longer.

Getting there requires understanding two things: what an EGFR mutation is, and why surgery alone is often not enough.

The mutation that defines the group

EGFR stands for epidermal growth factor receptor. It is a protein on the cell surface that receives a grow signal and passes it inward.

Certain mutations in the EGFR gene jam that switch on. The cell then behaves as if the signal never stops. Two changes account for most cases: a deletion in exon 19, and a single change called L858R.

NCI reports how unevenly these appear. In one large series of lung adenocarcinomas, those two EGFR changes were found in 52% of tumors from people who had never smoked, 15% from former smokers, and 6% from current smokers.

Osimertinib blocks the jammed receptor. It only works if the mutation is there, which is why the tumor has to be tested first. Our page on biomarker testing explains what that report looks like.

Why surgery alone leaves a gap

Removing a lung tumor completely is called a resection. When the pathologist finds no cancer at the edges, the operation has done its job.

Yet the cancer comes back for many people. The reason is cells that left the tumor before surgery and are too few to see on any scan. Treatment aimed at those cells is called adjuvant treatment.

What the trial did

ADAURA was a phase 3, double-blind, randomized trial. Double-blind means neither the patient nor the doctor knew who was getting which pill.

A total of 682 people were randomly assigned. Everyone had stage IB to IIIA non-small cell lung cancer with an EGFR mutation, completely removed by surgery. Some had also had chemotherapy.

Half got osimertinib, 80 mg once a day. Half got a placebo. Treatment ran for up to three years. The main measure was disease-free survival among people with stage II to IIIA disease, meaning time alive without the cancer returning.

What it found

At 24 months, 90% of the osimertinib group with stage II to IIIA disease were alive and disease-free, against 44% on placebo. The hazard ratio was 0.17.

A hazard ratio compares the rate of an event between two groups. At 0.17, the risk of recurrence or death at any given moment was about 83% lower with osimertinib.

Across the whole stage IB to IIIA group, the figures were 89% versus 52%, with a hazard ratio of 0.20.

The brain result mattered too. At 24 months, 98% of the osimertinib group and 85% of the placebo group were alive without cancer in the central nervous system. Lung cancer with EGFR mutations has a habit of spreading to the brain, and osimertinib crosses into it.

The 2023 final analysis answered the question everyone asks about a delay in recurrence: does it translate into living longer? Among people with stage II to IIIA disease, five-year overall survival was 85% with osimertinib and 73% with placebo, with a hazard ratio for death of 0.49.

When to get checked

Lung cancer is one of the few cancers with a screening test that reduces deaths. NCI states that low-dose helical CT is the only screening method shown to change lung cancer mortality. Chest X-ray and sputum tests did not.

The U.S. Preventive Services Task Force sets the threshold precisely. Annual low-dose CT is recommended for adults aged 50 to 80 who have a 20 pack-year smoking history and who currently smoke or quit within the past 15 years. A pack-year means one pack a day for one year, so it also equals half a pack a day for two years.

Symptoms are a separate route. NCI lists the most common presenting symptoms as a worsening cough, chest pain, coughing up blood, feeling generally unwell, weight loss, breathlessness, and hoarseness. Difficulty swallowing or swelling of the face and neck can point to a tumor pressing on nearby structures.

Never having smoked does not rule lung cancer out. EGFR-mutated lung cancer is disproportionately a disease of people who never smoked, which is exactly why a persistent cough in a non-smoker still deserves a chest image.

What this story cannot tell you

• It applies only to non-small cell lung cancer with an EGFR mutation, completely removed by surgery. Without the mutation, the drug does not work.
• The main measure was disease-free survival. That was later supported by survival data, but the two are not the same thing.
• Three years of daily treatment carries side effects, cost, and the burden of taking a drug while feeling well.
• Trial participants were selected against strict rules, so results may not carry across to everyone with the same stage.
• This says nothing about people whose cancer was not fully resectable. Our page on lung cancer covers those situations.

The wider picture

About 229,410 new lung and bronchus cancer diagnoses and about 124,990 deaths are projected in the United States for 2026 — American Cancer Society numbers, republished by SEER — the highest of any cancer. SEER's own measurement of five-year relative survival across all stages was 29.5% for 2016 to 2022, and 51% of cases are already distant at diagnosis.

Those numbers describe a whole population over past years of care. They are not a forecast for anyone, and they average across people whose cancer was found at very different points. ADAURA speaks only to the minority found early enough to operate on, with a specific mutation. For what trials in general can and cannot settle, see clinical trial phases.

Sources

• Wu YL, Tsuboi M, He J, et al. Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer. N Engl J Med 2020;383:1711-1723
• Tsuboi M, Herbst RS, John T, et al. Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC. N Engl J Med 2023;389:137-147
• NCI PDQ: Non-Small Cell Lung Cancer Treatment (Health Professional Version)
• SEER Cancer Stat Facts: Lung and Bronchus Cancer
• USPSTF: Lung Cancer Screening

How this page was made

An AI-assisted editorial system helped prepare this page. No named medical reviewer has reviewed it unless one is listed.

Cancer Explained is published by the National Cancer Information Foundation. It is not medical advice and does not suggest a test or treatment.

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