NCT05647330

Hydroxychloroquine Combined With Gemcitabine in the Treatment of Advanced Non-small Cell Lung Cancer

Phase II Clinical Study of Hydroxychloroquine Combined With Gemcitabine in the Treatment of Advanced Non-small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of hydroxychloroquine (600mgBID) combined with gemcitabine (1000mg/m2,d1,8) in the third-line and above treatment of advanced NSCLC.

Detailed description

This study is a single-arm, open phase II prospective cohort study to evaluate the efficacy and safety of hydroxychloroquine (600mgBID) combined with gemcitabine in the treatment of advanced NSCLC patients with third-line and above treatment. After signing informed consent, the subjects were screened and eligible for inclusion in this study. All enrolled subjects will be treated with (hydroxychloroquine 600mgBID) plus gemcitabine, and each patient will continue to receive the study drug until the end of the treatment cycle. The efficacy index and safety index were observed during the treatment. 1. Hydroxychloroquine sulfate tablets: twice a day, each time (600mg). Continuous oral administration. Until the disease progresses or becomes intolerable. 2. gemcitabine was administered intravenously at a dose of 1000mg/m2 for 30min,d1, 8, and every 3 weeks (21 days) until disease progression or intolerable toxicity, with a maximum duration of 2 years.

Conditions

• Hydroxychloroquine
• Gemcitabine
• Lung Neoplasms

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine Combined With Gemcitabine	Hydroxychloroquine combined with chemotherapy

Timeline

• Start date: 2022-12-15
• Primary completion: 2024-10-01
• Completion: 2025-10-01
• First posted: 2022-12-12
• Last updated: 2022-12-12