Efficacy, safety and economy of Zi-Long-Jin tablets in the maintenance of advanced non-small cell lung cancer (qi and blood deficiency syndrome): a multicenter, randomized, double-blind, placebo-contr

Phase 4

Conditions: non-small cell lung cancer

Registration Number: ITMCTR1900002807

Lead Sponsor: The First Affiliated Hospital of Tianjin 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) pathological histology and/or cytology diagnosis IIIb ~ IV non-small cell lung cancer;
2) patients who met the syndrome differentiation diagnosis of qi and blood deficiency syndrome in traditional Chinese medicine before enrollment;
3) the disease was stable after >=4 cycles of first-line chemotherapy (whole-brain radiotherapy was allowed to be used in patients with forebrain metastasis to a stable state), and within 30 days after the end of chemotherapy;
4) at least 1 measurable lesion (RECIST standard version 1.1);
5) ECOG score <=2, expected to survive for more than 3 months;
6) before enrollment, the adverse events occurred during chemotherapy were determined by the researcher according to CTCAE to have recovered to level 1 (except hair loss);
7) Aged 18 ~ 80 years old;
8) those who voluntarily participate in the study and have signed the informed consent.

Exclusion Criteria

1) uncontrolled brain metastases;
2) patients with positive gene test results of specific targeted therapy (EGFR positive or ALK positive or ROS1 positive or pd-l1 >=50%) before enrollment;
3) the laboratory examination met any of the following criteria: white blood cells < 3.0x10^9/L, neutrophils < 1.5x10^9/L, platelets < 6x10^10/L, red blood cells < 2x10^12/L, hemoglobin < 8.0g/dl, ALT, AST or Scr exceeding 2 times the normal upper limit, and blood bilirubin exceeding 1.5 times the normal upper limit;
4) patients with severe and uncontrolled organic disease or infection, such as decompensated heart, lung and renal failure, which lead to intolerance of chemotherapy;
5) patients with severe bleeding tendency or bleeding disease;
6) patients with other primary malignancies within 5 years or currently;
7) mental illness, drug or alcohol abuse;
8) patients during pregnancy, lactation or pregnancy possibility or planned pregnancy;
9) allergy or allergy to this medicine;
10) have participated in or are participating in other clinical trials within the previous 3 months;
11) the researcher believes that there are any other ineligible conditions.