lung cancer
Conditions
Interventions
Treatment group:Platinum-based doublet chemotherapy ± bevacizumab + JDQQ Formula
Control group:Platinum-based doublet chemotherapy ± bevacizumab + JDQQ Formula placebo
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 74 Years
Inclusion criteria
Inclusion criteria: (1) Diagnosed with non-squamous non-small cell lung cancer (NSCLC) by tissue or cellular pathology, with the American Joint Committee on Cancer (AJCC) lung cancer TNM staging at stage IV (8th edition); (2) Carrying EGFR sensitive mutations, with negative T790M on rebiopsy or failure of third-generation TKI treatment and disease progression; (3) ECOG score of 0-2; age between 18 and 74 years inclusive, gender not limited; (4) Syndrome differentiation type is Yin-deficiency; (5) According to the RECIST 1.1 criteria, at least one measurable lesion is present; (6) Expected survival period of at least 3 months; (7) Subjects have no major organ dysfunction, and blood routine, liver, kidney, and heart functions meet the following: hemoglobin =100g/L, absolute neutrophil count (ANC) =1.5×10^9/L, platelet count =80×10^9/L, bilirubin =1.5 times the upper limit of normal (ULN), alkaline phosphatase (AP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) =2.5 times ULN, international normalized ratio (INR) =1.5, and creatinine =1.5 times ULN. (8) Volunteers to join the study, sign the informed consent form, with good expected compliance and cooperation for follow-up.
Exclusion criteria
Exclusion criteria: (1) Symptomatic brain metastases; (2) Post-resistance genetic testing reveals mutations such as EGFR C797S, MET exon 14 skipping mutations, HER-2 (ERBB2) amplification/mutations, ALK fusions, RET rearrangements, ROS1 fusions, BRAF V600E, NTRK fusions, KRASG12C, etc., for which targeted therapies are available; (3) Currently undergoing or preparing for lung radiotherapy; (4) Patients with uncontrollable psychiatric diseases; (5) Severe, uncontrolled organic diseases or infections, such as decompensated heart, lung, or kidney failure, making them unable to tolerate chemotherapy; (6) Received treatment with small molecule clinical trial drugs within the last 28 days or large molecule clinical trial drugs within the last 3 months; (7) Known allergy to the study drugs or intolerance to them.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS rate;OS;Disease control situation;Quality of life;TCM (Traditional Chinese Medicine) clinical syndrome scoring;Tumor markers; | — |
Countries
China
Contacts
Public ContactXu Ling
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of traditional Chinese Medicine
Outcome results
None listed