NCT03986528

Clinical Trial of Kanglaite Injection (KLTi) in Advanced Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial on the Survival Advantage of Kanglaite Injection (KLTi) in Advanced Non-Small Cell Lung Cancer (NSCLC)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 334 (estimated)
• Sponsor: Jie Li · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Kanglaite Injection for advanced non-small cell lung cancer(NSCLC).

Detailed description

This study include a multicenter, randomized, controlled post-market clinical trial.The randomized clinical trial will enroll approximately 334 patients. Participants will be randomly divided into experimental (n=167) and control groups (n=167).Patients in the experimental group will receive Kanglaite Injection combination with first-line chemotherapy based on NCCN Guidelines (2019.V3). Patients in the control group will receive first-line chemotherapy based on NCCN Guidelines (2019.V3).The primary endpoint is PFS(progression free survival).The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Kanglaite Injection+Chemotherapy	Patients will receive investigator's choice of paclitaxel (135mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or pemetrexed (500mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or gemcitabine(1000mg/m2 by IV infusion on Days 1,8 of each 21-28 day cycle) PLUS cisplatin (75mg/m2 by IV infusion on Days 1 to 3 of each 21-28 day cycle) or carboplatin (AUC 6 by IV infusion on Days 1 of each 21-28 day cycle) according pathologic types. Patients with CR, PR, or SD after 4-6 cycles of platinum-based double chemotherapy regimens will receive non-platinum single-agent chemotherapy. The patients will also receive Kanglaite injection 200ml by IV infusion per day continuously for 14 days, commencing on the first day of chemotherapy.
DRUG	Chemotherapy	Patients will receive investigator's choice of paclitaxel (135mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or pemetrexed (500mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or gemcitabine(1000mg/m2 by IV infusion on Days 1,8 of each 21-28 day cycle) PLUS cisplatin (75mg/m2 by IV infusion on Days 1 to 3 of each 21-28 day cycle) or carboplatin (AUC 6 by IV infusion on Days 1 of each 21-28 day cycle) according pathologic types. Patients with CR, PR, or SD after 4-6 cycles of platinum-based double chemotherapy regimens will receive non-platinum single-agent chemotherapy.

Timeline

• Start date: 2019-08-28
• Primary completion: 2022-03-31
• Completion: 2022-05-31
• First posted: 2019-06-14
• Last updated: 2021-02-23

Locations

17 sites across 1 country: China