Clinical Study on the Prevention of Driver Gene Negative Ib-IIIb Lung Cancer Recurrence and Metastasis by Staged Chinese Herbal Medicine Combined With Chemotherapy and Immune Checkpoint Inhibitors

This project adopts a prospective, multicenter, randomized controlled clinical study to investigate the treatment of TCM in postoperative patients with driver gene negative lung cancer, according to two phases of postoperative adjuvant therapy: (i) chemotherapy phase immunotherapy phase. In this study, 367 patients (183 in the control group and 184 in the trial group) will be observed over 4 years, and the quality of life, toxic effects and safety of this therapy will be investigated. This study will provide evidence-based evidence for the establishment and optimization of a new model of posto

Trial Details

NCT ID
NCT05834413
Phase
NA
Sponsor
Shanghai University of Traditional Chinese Medicine
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • chemotherapy plus TCM 1&ICIs plusTCM2
  • chemotherapy plus TCM 1placebo &ICIs plus TCM2 placebo
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Patients who underwent complete surgical resection (R0) with postoperative pathology confirmed as stage Ib to IIIb non-small cell lung cancer.
  • Patients whose tissue or blood specimens tested negative for driver genes.
  • Patients who received their first chemotherapy within 8 weeks postoperatively.
  • Age ≥ 18 years ≤ 74 years, regardless of gender.

For full eligibility, visit ClinicalTrials.gov.

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