Non small cell lung cancer
Conditions
Interventions
Study Arm:PD-1 inhibitor + Platinum-based doublet chemotherapy + Jiawei-Gegen Qinlian Granule
Control Arm:PD-1 inhibitor + Platinum-based doublet chemotherapy + Placebo for Jiawei-Gegen Qinlian Granule
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Age 18-75 years. 2)ECOG performance status (PS) score of 0 or 1 with an estimated life expectancy = 3 months. 3)Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) classified as stage IIIB or IV according to the AJCC (American Joint Committee on Cancer) TNM staging system (8th Edition). 4)Absence of known driver gene mutations detected by molecular testing including EGFR sensitizing mutations ALK fusions ROS1 fusions BRAF V600 mutation NTRK fusions RET fusions MET exon 14 skipping mutation and MET amplification. 5)No prior anti-tumor systemic therapy received. 6)Diagnosed with dampness-heat syndrome (shi rè zhèng) according to Traditional Chinese Medicine pattern differentiation. 7)Presence of at least one measurable target lesion (longest diameter > 1.0 cm). 8)PD-L1 expression < 50%. 9)Participants voluntarily agree to participate in the study provide written informed consent after understanding the study procedures and demonstrate good compliance.
Exclusion criteria
Exclusion criteria: 1)Patients with active brain metastases that are symptomatic require treatment or are undergoing radiotherapy or other related therapy. 2)Stage III patients deemed potentially eligible for curative surgery. 3)Patients with another concurrent primary malignancy requiring active treatment. 4)Patients with contraindications to immunotherapy identified during baseline pre-immunotherapy evaluation. 5)Patients with severe concurrent primary diseases of the heart cerebrovascular system liver kidneys hematopoietic system or other major organs. 6)Pregnant or breastfeeding women and patients with psychiatric disorders intellectual impairment or language barriers. 7)Patients unable to cooperate with completing baseline assessments. 8)Patients with a history of oral allergy contraindication or intolerance to any major component of Jiawei-Gegen Qinlian Granule. 9)Participation in another investigational drug trial within 4 weeks prior to randomization (considering the washout period from the last dose of the previous trial's treatment). 10)Any other concurrent condition that in the judgment of the investigator would pose a serious risk to participant safety compromise the ability to complete the study or otherwise make the participant unsuitable for participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gut microbiota;Lymphocyte subpopulation;Tumor maker;Cytokines;Incidence of immune related adverse events;Quality of life;Duration of Therapy;Progression free survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactHuijuan Cui
China-Japan Friendship Hospital
Outcome results
None listed