A multicenter, randomized, controlled, open Phase II trial of adjuvant ectinib (24 months) after complete resection of non-small cell lung cancer (NSCLC) with high-risk factors in Stage IA

Phase 2

Recruiting

• Conditions: non-small cell lung cancer

• Registration Number: ChiCTR2400088956
• Lead Sponsor: Sun Yat-sen University Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. R0 resection, pathologically confirmed stage IA non-small cell lung cancer (NSCLC) with micropapillary subtype or STAS in the pathological type;<br>2) EGFR19 exon deletion or exon 21 L858R mutation;<br>3) Patients who can receive adjuvant therapy 3-8 weeks after surgery<br>4) Age =18 years or =70 years<br>5) The physical state score (ECOG PS) of Eastern Tumor Collaboration Group was 0-1<br>6) Lung function: FEV1 > 50<br>7) Blood system: neutrophil absolute value (ANC)=2.0×10^9/ L, platelets =100×10^9/L, hemoglobin =9g/dl;<br>8) Liver: bilirubin =1.5 times the upper limit of normal (ULN), glutamic oxalic aminotransferase (AST), alanine aminotransferase (ALT)=2.5 times ULN<br>9) Kidney: serum creatinine = 1.25x ULN or creatinine clearance =60ml/min<br>10) Women of childbearing age must use contraception during treatment and for three months after the end of treatment; Men of childbearing age who take contraceptive measures during treatment and within 3 months after the end of treatment;<br>11) Subjects are able to comply with study and follow-up procedures, understand and voluntarily sign written informed consent.

Exclusion Criteria

1. History of malignant tumor;<br>2) In this study, there were patients who underwent left or right total lung resection;<br>3) Patients with drug resistance mutations such as exon 20 T790M mutation;<br>4) History of interstitial lung disease or imaging evidence of interstitial pneumonia, or systemic disease involving the lungs;<br>5) There are other organ diseases that affect patient survival or targeted drug metabolism;<br>6) Digestive diseases or surgeries that affect drug absorption;<br>7) Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia;<br>8) Blood system: absolute value of neutrophil (ANC) < 2.0×10^9/ L, platelets < 100×10^9/L, hemoglobin < 9g/dl;<br>9) Liver: bilirubin > 1.5 times upper limit of normal (ULN), glutamic oxalic aminotransferase (AST), alanine aminotransferase (ALT) > 2.5 times ULN;<br>10) Kidney: serum creatinine > 1.25x ULN or creatinine clearance < 60ml/min;<br>11) Allergic to ectinib;<br>12) Women who are pregnant or nursing or planning to become pregnant; Male patients with family planning;<br>13) The investigator believes that the subject may not be able to complete the study or may not be able to meet the requirements of the study (for administrative reasons or otherwise);<br>14) There are other malignant tumor lesions;<br>15) Those without informed consent due to psychological, family, social and other factors.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3-year disease-free survival rate;

Secondary Outcome Measures

Name	Time	Method
Five-year overall survival rate;Safety and tolerability;Risk factors for poor efficacy;