Evidence map›Paper›PMID 40162917›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2025

Randomized Phase III Study of EGFR Tyrosine Kinase Inhibitor and Intercalated Platinum-Doublet Chemotherapy for Non-Small Cell Lung Cancer Harboring EGFR Mutation.

Shintaro Kanda, Seiji Niho, Takayasu Kurata, Shogo Nomura, Yosuke Kawashima, Eiji Iwama, Toshihide Yokoyama, Yasutaka Watanabe, Hiroshi Tanaka, Yutaka Fujiwara and 10 more

Abstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–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

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. 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

20 authors.

Shintaro KandaShinshu Cancer Center, Shinshu University Hospital, Matsumoto, Japan.ORCID 0000-0001-7864-3928
Seiji NihoDepartment of Pulmonary Medicine and Clinical Immunology, Dokkyo Medical University, Mibu, Japan.ORCID 0000-0001-9480-5923
Takayasu KurataDepartment of Thoracic Oncology, Kansai Medical University Hospital, Osaka, Japan.ORCID 0000-0003-4123-3567
Shogo NomuraDepartment of Biostatistics and Bioinformatics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.ORCID 0000-0001-8734-6984
Yosuke KawashimaDepartment of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.ORCID 0000-0002-9824-6572
Eiji IwamaDepartment of Respiratory Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.ORCID 0000-0001-8252-290X
Toshihide YokoyamaDepartment of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan.ORCID 0000-0002-5595-5010
Yasutaka WatanabeDepartment of Thoracic Oncology, Saitama Cancer Center, Saitama, Japan.ORCID 0000-0002-3679-4864
Hiroshi TanakaDepartment of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan.ORCID 0000-0002-8003-7326
Yutaka FujiwaraDepartment of Thoracic Oncology, Aichi Cancer Center, Nagoya, Japan.ORCID 0000-0001-6981-0800
Yoshitaka ZenkeDepartment of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0002-7641-9065
Koichi AzumaDivision of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Kurume-Shi, Japan.ORCID 0000-0001-5040-5856
Hirokazu TaniguchiDepartment of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.ORCID 0000-0003-2414-8344
Ryo ToyozawaDepartment of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.ORCID 0009-0002-7688-5725
Yukio HosomiDepartment of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.ORCID 0000-0002-3849-5905
Haruyasu MurakamiDivision of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.ORCID 0000-0003-2416-546X
Satoshi HaraDepartment of Respiratory Medicine, Itami City Hospital, Itami, Japan.ORCID 0000-0003-1936-7163
Akihiro BesshoDepartment of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan.ORCID 0000-0002-0394-7377
Nobuyuki YamamotoInternal Medicine III, Wakayama Medical University, Wakayama, Japan.ORCID 0000-0002-7342-0853
Yuichiro OheDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0002-6137-073X

Funding

Japan Agency for Medical Research and Development (AMED) JP18ck0106221 and JP22ck0106492National Cancer Center Japan (NCC) 2020-J-3National Cancer Center Japan (NCC) 2023-J-03National Cancer Center Japan (NCC) 26-A-4National Cancer Center Japan (NCC) 29-A-3
6 · The paper itself

Abstract

purposeThis study was performed to confirm the superiority in overall survival (OS) of EGFR tyrosine kinase inhibitor (TKI gefitinib or osimertinib) monotherapy versus EGFR TKI with intercalation of cisplatin plus pemetrexed as the first-line treatment for patients with advanced non-squamous non-small cell lung cancer (NSqNSCLC) harboring EGFR mutation. PATIENTS AND

methodsThis was an open-label, multicenter, randomized phase III study. Patients with chemotherapy-naïve advanced or recurrent NSqNSCLC harboring EGFR mutation (exon 19 deletion or exon 21 L858R point mutation) were randomly assigned (1:1) to EGFR-TKI monotherapy or the EGFR TKI plus intercalated chemotherapy group. The primary endpoint was OS, and the secondary endpoints included progression-free survival (PFS).

resultsFrom December 2015 to October 2020, 501 patients were randomized. The EGFR TKI was changed from gefitinib to osimertinib in October 2018 (gefitinib cohort: n = 308 and osimertinib cohort: n = 193). There was no survival advantage in the EGFR TKI plus intercalated chemotherapy group; the median survival time of both groups was 48.0 months (HR, 0.985; 91.4% confidence interval, 0.796-1.219; one-sided P = 0.4496). The median PFS time was 12.0 months in the EGFR-TKI monotherapy group and 18.0 months in the EGFR TKI plus intercalated chemotherapy group (HR, 0.762; 95% confidence interval, 0.628-0.925; one-sided P = 0.003). The OS and PFS trends in both gefitinib and osimertinib cohorts were identical to those in the entire population.

conclusionsThe intercalation of cisplatin plus pemetrexed after the response to EGFR TKI improved PFS but not OS compared with EGFR TKI monotherapy as the first-line treatment for patients with advanced NSqNSCLC harboring EGFR mutation.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungLung NeoplasmsMutationProtein Kinase InhibitorsAcrylamidesAdultAgedAged, 80 and overAniline CompoundsCisplatinErbB ReceptorsFemaleGefitinibHumansIndolesAcrylamidesAniline CompoundsCisplatinEGFR protein, humanErbB ReceptorsGefitinibIndolesosimertinibPemetrexedProtein Kinase InhibitorsPyrimidinesTyrosine Kinase Inhibitors

Identifiers

PMID40162917
PMCPMC12163600

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Registered trials

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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.