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Real World Study of Icotinib in Adjuvant Post Surgical Treatment for Stage IA2 High Risk to IB EGFR Mutant Non Small Cell Lung Cancer

ConditionNSCLC (Non-small Cell Lung Cancer)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBetta Pharmaceuticals Co., Ltd.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

1. A history of other malignancies within 5 years prior to lung cancer surgery, with the exception of curatively treated malignancies.

2.Prior receipt of systemic anti-tumor therapy for NSCLC within 6 months before lung cancer surgery or before disease recurrence and metastasis.

Trial population

Patients with completely resected (R0) stage IA2 high-risk to IB non-small cell lung cancer (NSCLC) harboring EGFR-sensitizing mutations

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Icotinib

    Drug

    Icotinib，tablets, usually 125mg per dose (1 tablet), TID, orally

  • Routine Observational

    Other intervention

    Routine Observational Follow-up

Treatment groups

2,572 Participants
are divided into 2 treatment groups
Group A: Icotinib Group1 intervention
Group B: Routine Observational Group1 intervention

Trial outcomes

Primary outcomes

1

Overall survival period（OS）

Time frame
Data collection deadline (This study is a retrospective study and there is no predetermined evaluation time).The index date for this study is defined as 4 weeks following complete surgical resection (R0).

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Betta Pharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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