Icotinib after surgery for early EGFR-mutant NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, retrospective observational study using real-world data to compare outcomes of patients with completely resected stage IA2 high-risk to IB NSCLC harboring EGFR-sensitizing mutations who received adjuvant icotinib versus those who had routine postoperative observation. Eligible institutions must meet data-quality standards and contribute a sufficient sample size. Propensity score matching will be used to balance groups and assess efficacy and safety of adjuvant icotinib in this population. The treatment arm includes patients treated with icotinib after R0 resection, while controls are historically observed post-surgery without anti-tumor therapy until recurrence or metastasis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Shanghai Pulmonary Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Investigating KQB365 for treating advanced solid tumors

  This study tests if a new treatment called KQB365, alone or with another drug, can help adults with advanced solid tumors that have specific genetic mutations.

  Recruiting at 11 sites Phase 1 Kumquat Biosciences Inc. · Phoenix, Arizona and 10 other locations · NCT06720987

• TS-104: a first-in-human, dose-escalation study for advanced solid tumors

  This study tests TS-104, a peptide-drug conjugate, as a single therapy in adults with advanced solid tumors like NSCLC, HNSCC, esophageal, gastric, ovarian, or endometrial cancer to see if it is safe and tolerable and whether it shows any benefit.

  Recruiting at 3 sites Phase 1 TwoStep Therapeutics, Inc. · Maumee, Ohio and 2 other locations · NCT07814248

• Oral Paclitaxel with Immunotherapy and SBRT as Neoadjuvant Treatment for Older Adults with NSCLC

  This trial tests a new, lighter neoadjuvant therapy that combines an oral paclitaxel solution, an immune checkpoint inhibitor, and SBRT for adults aged 70 and older with resectable NSCLC to see if it can shrink tumors before surgery.

  Recruiting Phase 4 Shanghai Pulmonary Hospital, Shanghai, China · Guangzhou, Guangdong and 4 other locations · NCT07754812

• Targeted Induction Therapy for Stage III Unresectable EGFR Mutant NSCLC

  This trial tests a targeted induction approach using fumetinib with platinum-based chemotherapy and concurrent radiochemotherapy in adults with unresectable stage III EGFR-mutant NSCLC to see if this combo can improve outcomes before possible surgery.

  Recruiting Phase 2 Shanghai Pulmonary Hospital, Shanghai, China · Shanghai, Shanghai Municipality · NCT07742332

• Pralsetinib Drug Interaction Study in RET Fusion/MUTATION Positive Solid Tumors

  This trial tests whether pralsetinib changes how the body processes certain medicines in adults with RET fusion- or mutation-positive advanced solid tumors.

  Recruiting at 2 sites Phase 4 Rigel Pharmaceuticals · Logroño, La Rioja and 1 other locations · NCT07704658

• GFH375 vs. Docetaxel for KRAS G12D-mutant NSCLC

  This study tests whether GFH375 can help people with KRAS G12D-mutant NSCLC more than docetaxel.

  Recruiting Phase 3 Genfleet Therapeutics (Shanghai) Inc. · Shanghai, Shanghai Municipality · NCT07668752

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.