Yiqi Yangyin Jiedu decoction combined with chemotherapy in the treatment of advanced lung adenocarcinoma with EGFR sensitive mutation after TKI resistance: a randomized controlled double-blind study

Phase 4

Conditions: on-small cell lung cancer

Registration Number: ITMCTR2000003622

Lead Sponsor: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Patients with stage IIIB or IV lung adenocarcinoma without chemotherapy confirmed by pathology or cytology carried EGFR gene mutations, including exon 19 deletion mutation (19del) and exon 21 point mutation (21l858r).
2. The patients who had been treated with EGFR-TKI for more than 3 months showed a rapid increase in tumor load and symptom score <= 2;
3. No new gene mutation was detected after drug resistance, and the patients who were going to be treated with platinum containing dual drug chemotherapy as the second-line treatment;
4. Patients with deficiency of both qi and Yin according to TCM syndrome differentiation;
5. Patients aged 18-74 years, regardless of gender;
6. Patients with ECoG score of 1-2 and expected survival time >= 3 months;
7. For patients without major organ dysfunction, blood routine test, liver, kidney and heart function meet the following requirements: hemoglobin >= 120g / L, absolute neutrophil count (ANC) >= 1.5 * 10^9 / L, platelet >= 80 * 10^9 / 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. Patients with other tumor history within 5 years;
2. Those who carry T790M mutation and plan to use EGFR-TKI third generation drugs or meet the second-line targeted therapy and immunotherapy;
3. Patients who have a history of radiotherapy and are ready to receive radiotherapy in recent 2 months
4. Symptomatic brain metastases;
5. Those who have been or are participating in other clinical studies;
6. History of cardiovascular disease: congestive heart failure > NYHA class II. Patients with unstable angina (angina symptoms resting) or new onset angina (starting in the last 3 months) or myocardial infarction occurred in the past 6 months. Active infection, > grade 2 adverse events (CTC AE. 5.0);
7. Pregnant or lactating patients;
8. Patients with uncontrollable mental history.