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Icotinib after surgery for early EGFR-mutant non-small cell lung cancer

Reviews past records of icotinib versus follow-up after lung cancer surgery.

Key facts

Who runs it
Betta Pharmaceuticals Co., Ltd.
Where
Beijing and Shanghai, ChinaSee the 2 sites
Trial code
Registry title
Real World Study of Icotinib in Adjuvant Post Surgical Treatment for Stage IA2 High Risk to IB EGFR Mutant Non Small Cell Lung Cancer
Status
Recruiting
People taking part
2,572 people, planned
Started
Sept 2026
Expected to end
Jun 2027
Type of study
Observational, 2 groups
Treatments tested
  • Icotinib
  • Routine Observational
Record updated
8 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial looks back at adults whose early-stage non-small cell lung cancer with an EGFR-sensitizing mutation was fully removed by surgery. It compares those who took icotinib afterwards with those who were only watched.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Non-small cell lung cancer, mostly non-squamous (adenocarcinoma), stage IA2 high risk to IB, fully removed by surgery (R0).
Earlier treatment
Control group: no anti-tumour treatment after surgery until the cancer came back or spread. Cannot have had systemic anti-tumour treatment for NSCLC within 6 months before surgery or before recurrence or spread.
Biomarker or test result
EGFR-sensitizing mutation found in the tumour tissue taken at surgery, using an approved test.

Main reasons for not taking part

  • Another cancer in the 5 years before lung cancer surgery, unless it was treated with the aim of removing it completely
  • Systemic anti-tumour treatment for NSCLC within 6 months before surgery or before recurrence or spread

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • 1. Histologically confirmed primary non small cell lung cancer (NSCLC), predominantly non squamous histology (including adenocarcinoma or mixed carcinoma with a major adenocarcinoma component)
  • 2. Pathologically confirmed stage IA2 high risk to IB NSCLC following complete surgical resection (R0) of primary lung cancer. Disease staging follows the 8th edition of the AJCC/UICC lung cancer staging system
  • 3. Post surgical tumour tissue specimens test positive for EGFR sensitizing mutations using an approved assay
  • 4. Patients in the control group received postoperative observation without any anti tumour therapy prior to disease recurrence or metastasis

Who cannot take part

  • 2.Prior receipt of systemic anti-tumor therapy for NSCLC within 6 months before lung cancer surgery or before disease recurrence and metastasis
  • 1. A history of other malignancies within 5 years prior to lung cancer surgery, with the exception of curatively treated malignancies

Where in China

  • Beijing Cancer HospitalBeijing, ChinaContact: Nan WuTaking people
  • Shanghai Pulmonary HospitalShanghai, ChinaContact: Chang ChenTaking people

About the trial

What the trial wants to find out

This is a multicenter, retrospective, observational real-world study designed based on real-world data. Eligible medical institutions that meet standardized data quality requirements and have an adequate sample size will be enrolled in this study. The treatment group consists of patients with completely resected (R0) stage IA2 high-risk to IB non-small cell lung cancer (NSCLC) harboring EGFR-sensitizing mutations who received adjuvant icotinib therapy after radical resection. The control group includes patients with completely resected (R0) stage IA2 high-risk to IB NSCLC with positive EGFR-sensitizing mutations who received routine observational follow-up after surgery. Propensity score-matched analyses will be conducted between the treatment and control groups to evaluate the efficacy and safety of adjuvant icotinib therapy in this patient population.

The 2 groups in the trial

  • Icotinib Group

    Patients with completely resected (R0) stage IA2 high-risk to IB non-small cell lung cancer (NSCLC) harboring EGFR-sensitizing mutations who received adjuvant icotinib therapy after radical resection.

    Treatment: Icotinib

  • Routine Observational Group

    Patients with completely resected (R0) stage IA2 high-risk to IB NSCLC with positive EGFR-sensitizing mutations who received routine observational follow-up after surgery.

    Treatment: Routine Observational

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Multicenter, Retrospective, Observational Study of Icotinib for Post-Surgical Adjuvant Therapy in Stage IA2 High-Risk to IB Non-Small-Cell Lung Cancer With Positive EGFR-Sensitive Mutations
Plain-language title
Icotinib after surgery for early EGFR-mutant non-small cell lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
8 September 2026