A randomized controlled, double-blind study of Chinese medicine combined with EGFR-TKI in the treatment of stage IV EGFR mutation-positive non-small cell lung cancer

Phase 3

• Conditions: on-small cell lung cancer

• Registration Number: ITMCTR1900002685
• Lead Sponsor: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

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

Inclusion Criteria

(1) pathological or cytological diagnosis of stage IV lung cancer with tumor patients;
(2) EGFR gene mutations, including exon 19 deletion mutation (19DEL), exon 21 point mutation (21L858R), 18 exon G719X, 20 exon S768I and 21 exon L861Q mutation are also sensitive Sexual mutation, T790M mutation.
(3) Age = 18 years old;
(4) The estimated survival period is = 3 months;
(5) The subject has no major organ dysfunction. Blood routine, liver, kidney, and cardiac function are normal: hemoglobin = 120g / L, absolute neutrophil count (ANC) = 1.5 × 109 / L, platelet = 80 × 109 / L, bilirubin = 1.5ULN, alkaline phosphatase (AP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 × ULN. INR = 1.5, creatinine = 1.5ULN.

Exclusion Criteria

(1) Have a history of other tumors within 5 years;
(2) T790M mutation carrying 20 exons, intended to be treated with EGFR-TKI first-generation drugs;
(3) Those with an expected life expectancy of <3 months;
(4) symptomatic brain metastases;
(5) History of cardiovascular disease: congestive heart failure > level II in NYHA cardiac function. Patients with unstable angina (symptoms of angina at rest) or newly occurring angina (starting in the past 3 months) or myocardial infarction occurred in the past 6 months. Active infection, > Level 2 adverse events (CTC AE. Version 4.0);
(6) Pregnant or lactating patients;
(7) People with a history of mental illness that is difficult to control.

Study & Design

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