Tagrisso (Osimertinib) Trials: FLAURA, ADAURA and LAURA Explained

Tagrisso (osimertinib) has been tested in several large randomized trials, and each one asked a different question about a different stage of EGFR-mutated non-small cell lung cancer (NSCLC). People searching for “Tagrisso for stage 4 lung cancer,” “Tagrisso survival rate” or “FLAURA Tagrisso” are usually looking for these numbers. This guide lays out what each trial measured and reported, in the order the evidence arrived, as an analyst’s summary rather than advice. It does not say what any individual should expect.

Updated November 4, 2026.

What do these trials actually measure?

Two terms recur. Progression-free survival (PFS) is the time until the cancer grows or the patient dies; it can be measured sooner and shows how long disease stays controlled. Overall survival (OS) is the time until death from any cause; it needs longer follow-up and is affected by later treatments, including crossover from the comparison arm. Disease-free survival (DFS), used in early-stage trials, is the time until recurrence or death after surgery.

A median is the midpoint of a group: half did better, half worse. It is not a prediction for any one person, and different trials enroll different patients. Rather than a single “success rate,” the trials report hazard ratios (HR), where a figure below 1.0 means a lower risk of the event in the Tagrisso arm.

FLAURA: Tagrisso for stage 4 (metastatic) lung cancer, first-line

FLAURA (NCT02296125) randomized 556 previously untreated patients with EGFR exon 19 deletions or exon 21 L858R, 95% of them stage IV, to Tagrisso or to gefitinib or erlotinib. Per the FDA label, median PFS was 18.9 months with Tagrisso versus 10.2 months (HR 0.46). The final overall survival analysis showed median OS of 38.6 versus 31.8 months (HR 0.80, p=0.0462) (FDA Tagrisso label, section 14.3). The NEJM report of that analysis noted that crossover from the comparator group to Tagrisso likely contributed to the 31.8-month figure (ESMO summary of Ramalingam et al., NEJM 2020). The FDA approved first-line use on April 18, 2018, per AstraZeneca’s announcement (AstraZeneca).

ADAURA: after surgery for early-stage disease

ADAURA (NCT02511106) is a placebo-controlled trial in 682 patients with completely resected stage IB to IIIA disease, with treatment planned for 3 years. The FDA label reports DFS HR 0.20 in the whole population (stage IB-IIIA) and 0.17 in stage II-IIIA, and an OS HR of 0.49 in both groups; median OS was not reached in either arm, with 42 deaths (12%) versus 82 (24%) in the IB-IIIA population. The NEJM final analysis reported 5-year OS of 88% versus 78% in the overall population, from an analysis with relatively few deaths (ASCO Post). The FDA approved the adjuvant indication on December 18, 2020 (FDA). AstraZeneca’s Q3 2026 report also refers to an updated exploratory ADAURA analysis at WCLC 2026 showing a sustained survival benefit at eight years; that is a post hoc exploratory analysis.

LAURA: unresectable stage III after chemoradiation

LAURA (NCT03521154) randomized 216 patients 2:1 to Tagrisso or placebo after platinum-based chemoradiation had not caused progression. Median PFS by blinded independent review was 39.1 months versus 5.6 months (HR 0.16). The label states that OS results were immature, with 36% of the deaths needed for the final analysis reported, and that no trend toward harm was seen. The FDA approved this use on September 25, 2024 (FDA). Placebo-arm patients could be offered open-label Tagrisso after progression, which affects how later survival results are read.

AURA3 and FLAURA2: later-line and combination use

AURA3 (NCT02151981) enrolled 419 patients whose T790M-positive disease had progressed after an EGFR TKI, randomized 2:1 to Tagrisso or platinum-pemetrexed chemotherapy. Median PFS was 10.1 versus 4.4 months (HR 0.30). Final OS was 26.8 versus 22.5 months (HR 0.87), not statistically significant, with 71% of chemotherapy patients crossing over to Tagrisso. FDA accelerated approval came in November 2015 and regular approval in March 2017, per FDA’s summary (FDA D.I.S.C.O.).

FLAURA2 compared Tagrisso plus pemetrexed and platinum chemotherapy with Tagrisso alone in 557 patients (96% metastatic). Median PFS was 25.5 versus 16.7 months (HR 0.62), and the FDA approved the combination on February 16, 2024 (FDA). AstraZeneca’s final analysis reported median OS of 47.5 versus 37.6 months (HR 0.77, 95% CI 0.61-0.96) (ASCO Post); the combination carries more toxicity, covered in our FLAURA2 article.

Why trial medians are not individual predictions

Several cautions apply to every figure above. The trials enrolled selected patients, for example those with WHO performance status of 0 or 1, and the label describes 62% to 82% of participants in these trials as Asian. Medians describe groups, and the confidence intervals around them can be wide. Crossover, post-trial therapy and differing follow-up all affect OS. And PFS gains do not always translate into OS gains, as AURA3 shows. Finally, label wording matters: each indication is restricted to tumors with EGFR exon 19 deletions or exon 21 L858R (or, for AURA3, T790M), so these results apply to those groups only. For how these trials sit within the wider treatment map, see the osimertinib (Tagrisso) landscape article and the treatment algorithm overview. To check any trial record yourself, see how to read a ClinicalTrials.gov record.

Next step

Teams that need trial readouts like these tracked and interpreted as they arrive can look at ONCRG Sentinel from Oncology Resource Group.

This article is for informational and competitive-intelligence purposes only and is not medical advice. Approvals, labels and trial results change; verify details against current prescribing information and primary sources.