Evidence map›Paper›PMID 41581084›Full record

Observational studyJapanese journal of clinical oncology2026

Safety and effectiveness of selpercatinib in patients with RET fusion-positive non-small cell lung cancer in real-world clinical practice: a postmarketing study in Japan.

Yucherng Chen, Joji Mori, Satoshi Wakabayashi, Kevin Y Urayama

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Japanese journal of clinical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

4 authors.

Yucherng ChenSafety Medical, Global Patient Safety & Solutions, Eli Lilly Japan K.K., 5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan.
Joji MoriGlobal Statistical Science Japan, Eli Lilly Japan K.K., 5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan.
Satoshi WakabayashiJapan Drug Development & Medical Affairs, Eli Lilly Japan K.K., 5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan.
Kevin Y UrayamaPharmacoepidemiology, Global Patient Safety & Solutions, Eli Lilly Japan K.K., 5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan.ORCID 0000-0002-1360-9531

Funding

Eli Lilly Japan K.K., Hyogo, Japan
6 · The paper itself

Abstract

backgroundThis study assessed the safety and effectiveness of selpercatinib, a selective rearranged during transfection (RET) kinase inhibitor, in patients with RET fusion-positive non-small cell lung cancer (NSCLC) in real-world clinical practice in Japan.

methodsThis single-arm, multicenter, prospective observational study included patients with RET fusion-positive NSCLC who received at least one dose of selpercatinib between February 2022 and October 2023. Data were extracted from medical records and entered into an electronic data capture (eDC) system. Safety (adverse events [AEs] and AEs of special interest [AESIs]) and effectiveness (tumor response, overall survival [OS]) were assessed over 12 months.

resultsAmong 243 patients (median age: 67 years; 56% females), AEs occurred in 86.0% of patients, with Grade ≥ 3 AEs in 48.1% and serious AEs (SAEs) in 24.7%. The most common AEs (≥10%) included hypertension (23.5%), abnormal hepatic function (21.0%), rash (11.1%), aspartate aminotransferase increase (10.3%), and diarrhea (10.3%). AEs led to treatment modifications, including dose interruption (54.7%), dose reduction (14.8%), and discontinuation (6.2%). AESIs included liver injury (44.0%), hypertension-related events (23.9%), and hypersensitivity (MedDRA preferred term; 9.9%). The overall response rate was 58.8%, comprising complete response in 4.5% and partial response in 54.3% of patients. Median OS was not reached; the 12-month survival rate was 80.9% (95% CI, 74.9-85.6).

conclusionsReal-world data showed selpercatinib to be effective in patients with RET fusion-positive NSCLC in Japan, with a favorable safety profile and no new safety concerns.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsProtein Kinase InhibitorsProto-Oncogene Proteins c-retPyridinesAdultAgedAged, 80 and overFemaleHumansJapanMaleMiddle AgedProduct Surveillance, PostmarketingProspective StudiesPyrazolesProtein Kinase InhibitorsProto-Oncogene Proteins c-retPyrazolesPyridinesRET protein, humanselpercatinibeffectivenessNSCLCpostmarketingRET fusion-positivesafetySelpercatinib

Identifiers

PMID41581084
PMCPMC13070520

What Socratic holds

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LicenceCC BY
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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 Socratic graph.