Evidence map›Paper›PMID 36816343›Full record

ArticleEClinicalMedicine2023

Adjuvant icotinib versus observation in patients with completely resected EGFR-mutated stage IB NSCLC (GASTO1003, CORIN): a randomised, open-label, phase 2 trial.

Wei Ou, Ning Li, Bao-Xiao Wang, Teng-Fei Zhu, Zhi-Lin Shen, Tao Wang, Wu-Guang Chang, Zeng-Hao Chang, Xin-Xin Hu, Yue Pu and 2 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02264210 (A Randomized, Phase II Trial of Icotinib Versus Observation as Adjuvant Treatment in Stage IB Non-Small Cell Lung Cancer Harboring Activating Epidermal Growth Factor Receptor Mutation), which is not on this map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
11.6field-weighted citation impact, top 1% of its field
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.

NCT02264210 phase2completednot on this map

A Randomized, Phase II Trial of Icotinib Versus Observation as Adjuvant Treatment in Stage IB Non-Small Cell Lung Cancer Harboring Activating Epidermal Growth Factor Receptor Mutation

TypeinterventionalSponsorSun Yat-sen UniversityRan2015 to 2022Enrolled128ConditionsLung Neoplasms, Squamous Cell Lung Cancer, Adenocarcinoma of the Lung, Adenosquamous Cell Lung CancerArmsIcotinib
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Targeting ClassicalCancers · 2026
    Review
  7. Article
  8. Review
  9. Adjuvant chemotherapy before osimertinib inTranslational lung cancer research · 2025
    Article
  10. Article
  11. Article
  12. Clinicopathological factorsTranslational lung cancer research · 2025
    Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Article
  19. Review
  20. [Selection of postoperative adjuvant therapy for patients with stage IB lung adenocarcinoma: analysis of 653 cases].Nan fang yi ke da xue xue bao = Journal of Southern Medical University · 2024
    Article
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

12 authors at 4 institutions in 1 country.

Wei OuDepartment of Thoracic Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Ning LiDepartment of Breast Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Bao-Xiao WangDepartment of Otolaryngology, Head and Neck Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Teng-Fei ZhuDepartment of Thoracic Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Zhi-Lin ShenBetta Pharmaceuticals Co., Ltd., Hangzhou, China.
Tao WangDepartment of R&D, Hangzhou Repugene Technology Co., Ltd., Hangzhou, China.
Wu-Guang ChangDepartment of Thoracic Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Zeng-Hao ChangDepartment of Thoracic Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Xin-Xin HuDepartment of Thoracic Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Yue PuDepartment of R&D, Hangzhou Repugene Technology Co., Ltd., Hangzhou, China.
Lie-Ming DingBetta Pharmaceuticals Co., Ltd., Hangzhou, China.
Si-Yu WangDepartment of Thoracic Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Sun Yat-sen University · CNSun Yat-sen University Cancer Center · CNBetta Pharmaceuticals (China) · CNState Key Laboratory of Oncology in South China

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: This phase 2 trial aimed to compare adjuvant icotinib with observation in patients with epidermal growth factor receptor (EGFR) mutation-positive resected stage IB non-small cell lung cancer (NSCLC). Methods: We performed a randomised, open-label, phase 2 trial from May 1, 2015 to December 29, 2020 at Sun Yat-sen University Cancer Center in China. Patients with completely resected, EGFR-mutant, stage IB (the 7th edition of TNM staging) NSCLC without adjuvant chemotherapy were randomised (1:1) to receive adjuvant therapy with icotinib (125 mg, three times daily) for 12 months or to undergo observation until disease progression or intolerable toxicity occurred. The primary endpoint was 3-year disease-free survival (DFS). CORIN (GASTO1003) was registered with Clinicaltrials.gov, with the number NCT02264210. Findings: A total of 128 patients were randomised, with 63 patients in the icotinib group and 65 patients in the observation group. The median duration of follow-up was 39.9 months. The three-year DFS was significantly higher in the icotinib group (96.1%, 95% confidence interval [CI], 91.3-99.9) than in the observation group (84.0%, 95% CI, 75.1-92.9; P = 0.041). The DFS was significantly longer in the icotinib group than in the observation group, with a hazard ratio (HR) of 0.23 (95% CI, 0.07-0.81; P = 0.013). The OS data were immature, with three deaths in the observation arm. In the icotinib group, adverse events (AEs) of any grade were reported in 49 patients (77.8%), and grade 3 or greater AEs occurred in four patients (6.3%). No treatment-related deaths occurred. Interpretation: Our findings suggested that adjuvant icotinib improved the 3-year DFS in patients with completely resected EGFR-mutated stage IB NSCLC with a manageable safety profile. Funding: This study was sponsored by Betta Pharmaceutical Co., Ltd.

Indexed as

Adjuvant therapyIcotinibStage IB NSCLC

Identifiers

PMID36816343
PMCPMC9932314
OpenAlexW4319066765

What OpenQuestion holds

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Registered trials

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.