Evidence map›Paper›PMID 41801128›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2026

Patient-Reported Outcomes in FLAURA2: Osimertinib with or without Chemotherapy in Patients with Previously Untreated EGFR-Mutated Advanced Non-Small Cell Lung Cancer.

Jhanelle E Gray, Konstantin Laktionov, Sang-We Kim, Terufumi Kato, Jialei Wang, Zhigang Han, Paul Mitchell, Shoichi Kuyama, Jerry Tan Chun Bing, Juan Cundom and 8 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Jhanelle E GrayDepartment of Thoracic Oncology, Moffit Cancer Center, Tampa, Florida.ORCID 0000-0003-1304-7062
Konstantin LaktionovFederal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation, Moscow, Russia.ORCID 0000-0003-4469-502X
Sang-We KimDepartment of Oncology, Asan Medical Center, Seoul, South Korea.ORCID 0000-0003-1065-8095
Terufumi KatoDepartment of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.ORCID 0000-0002-5853-1424
Jialei WangDepartment of Thoracic Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.ORCID 0000-0001-9977-2219
Zhigang HanTumor Hospital of Xinjiang Medical University , Urumqi, China.ORCID 0000-0003-2135-4476
Paul MitchellOlivia Newton-John Cancer Wellness and Research Centre , Austin Hospital, Heidelberg, Australia.ORCID 0000-0001-7811-9667
Shoichi KuyamaDepartment of Respiratory Medicine, National Hospital Organization, Iwakuni Clinical Center, Yamaguichi, Japan.ORCID 0000-0002-6079-3511
Jerry Tan Chun BingCebu Doctors' University Hospital, Cebu City, Philippines.ORCID 0009-0000-2728-5331
Juan CundomInstituto de Investigaciones Metabólicas, Buenos Aires, Argentina.ORCID 0009-0004-3915-4522
Gustavo PintoFundação Pio XII Hospital de Câncer de Barretos, Barretos, Brazil.ORCID 0000-0002-3743-6380
Frances A ShepherdDepartment of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre, Toronto, Canada.ORCID 0000-0002-3610-3533
Lynne PooleBiometrics, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.ORCID 0009-0002-9460-1570
Rachel LaiClinical Outcomes Assessment, Evinova, AstraZeneca, Gaithersburg, Maryland.ORCID 0000-0003-2015-4835
Muna AlbayatyGlobal Clinical Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.ORCID 0009-0001-4743-0337
Neha P AminLate Development Oncology, Oncology R&D, AstraZeneca, Gaithersburg, Maryland.ORCID 0000-0002-2472-6522
Kunihiko KobayashiDepartment of Respiratory Medicine, Saitama Medical University International Medical Center, Hidaka, Japan.ORCID 0000-0002-6468-9068
Chee Khoon LeeDepartment of Medical Oncology, Cancer Care Centre, St. George Hospital, Kogarah, Australia.ORCID 0000-0003-2955-9820

Funding

AstraZeneca (AZ)
6 · The paper itself

Abstract

purposeIn FLAURA2, first-line osimertinib plus platinum-pemetrexed induction, with osimertinib plus pemetrexed maintenance, improved progression-free survival versus osimertinib alone in epidermal growth factor receptor (EGFR)-mutated, advanced non-small cell lung cancer (NSCLC; hazard ratio, 0.62; P < 0.001). Combining osimertinib with chemotherapy increased induction grade ≥3 adverse event rates, which reduced during maintenance. We report FLAURA2 patient-reported outcomes (PRO). PATIENTS AND

methodsHealth-related quality of life (HRQoL) was measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (baseline, week 4, week 7, week 10, then every 6 weeks until progression) and QLQ Lung Cancer 13 (baseline, weekly until week 10, then every 3 weeks until progression). Score changes (baseline to progression/19 months) were analyzed by mixed models for repeated measures. Within-patient ≥10-point changes from baseline were considered clinically meaningful. Tolerability was assessed by PRO-Common Terminology Criteria for Adverse Events (CTCAE).

resultsPatients had intermediate-to-high baseline functioning and global health status (GHS)/QoL (mean scores ≥63), with mild symptomatology (≤35). Most key scales showed nonclinically meaningful improvements; average least-squares mean (LSM) changes [95% confidence interval (CI)] for GHS/QoL and physical function, respectively, were 3.32 (1.67-4.98) and 2.37 (0.70-4.04) with combination therapy and 7.38 (5.70-9.07) and 6.74 (5.04-8.43) with monotherapy. Improvements in cough were clinically meaningful with combination therapy and monotherapy from week 5 (except monotherapy at week 73); average LSM changes (95% CI) were -13.23 (-14.85 to -11.62) and -11.19 (-12.83 to -9.55), respectively. Nonclinically meaningful deteriorations in fatigue and appetite loss were seen with the combination during induction. Both treatments were similarly well tolerated (PRO-CTCAE).

conclusionsIn FLAURA2, osimertinib monotherapy and combination with platinum-pemetrexed as first-line treatment for EGFR-mutated advanced NSCLC had nonclinically meaningful impacts on HRQoL in mildly symptomatic patients.

Indexed as

AcrylamidesAniline CompoundsAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungLung NeoplasmsMutationPatient Reported Outcome MeasuresAdultAgedErbB ReceptorsFemaleHumansIndolesMaleMiddle AgedPemetrexedAcrylamidesAniline CompoundsEGFR protein, humanErbB ReceptorsIndolesosimertinibPemetrexedPyrimidines

Identifiers

PMID41801128
PMCPMC13223547

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.