Non-Small Cell Lung Cancer (NSCLC) Clinical Trials

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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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Shanghai Pulmonary Hospital
RECRUITING
Shanghai
Time Frame
Start Date: 2026-09
Estimated Completion Date: 2027-06
Participants
Target number of participants: 2572
Treatments
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.
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.
Sponsors
Leads: Betta Pharmaceuticals Co., Ltd.

This content was sourced from clinicaltrials.gov