Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

ICI: PD-1 inhibitors selected by clinicians based on patients' condition

Chemotherapy: AP regimen（Pemetrexed 500mg/m2+carboplatin AUC=5,q3w） for non-squamous cancer patientsor or TP regimen（Paclitaxel 175mg/m2+carboplatin AUC=5, or albumin paclitaxel 100mg/m2+carboplatin AUC=5,q3w）for Squamous cancer patients.

Placebo: The particle size and color are similar to the HGXJT, and the smell and taste are close to the HGXJT, and the bacteria test is qualified

Bone-protecting and Mass-dispersesing Decoction: Chinese Herbal Formula,also named as HGXJT

Study summary

This is a double-blind, randomized controlled study evaluating the efficacy and safety of HGXJT in combination with ICI-based standard treatment in lung cancer patients with bone metastases. Enrolled participates will randomly receive HGXJT or placebo during the first 4-6 cycles of ICI-based standard treatment.

Eligibility

Primary outcome measure(s)

• (Disease control rate assessed by investigators) DCR (CR+PR+SD) — From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.
  DCR (disease control rate) is defined as sum of complete response (CR) rate, partial response (PR) rate and stable disease (SD) rate, according to RECIST v 1.1, based on the chest, abdomen and/or brain CT/MRI evaluation. Patients will undergo a follow-up imaging examination every 3 months, with an additional imaging examination after the first two cycles of treatment (normally 6 weeks).

Trial sites (1)

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