NCT03799094

Vitamin C and Tyrosine Kinase Inhibitor in Lung Cancer Patients With Epidermal Growth Factor Receptor Mutations

Clinical Outcomes of Intravenous Vitamin C Synergy With Tyrosine Kinase Inhibitor in Lung Adenocarcinoma Patients With Epidermal Growth Factor Receptor Mutations

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Clifford Hospital, Guangzhou, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial was to explore whether intravenous vitamin C can prolong resistance time of Tyrosine Kinase Inhibitor(TKI) on lung adenocarcinoma patients with Epidermal Growth Factor Receptor(EGFR) mutations, and can benefit NSCLC patients.

Detailed description

The effects of vitamin C in combination with tyrosine kinase inhibitor on tumor size, tumor markers, inflammatory factor levels, quality of life, duration of resistance, progression-free survival, and overall survival time were evaluated. This trial is a low risk treatment, and has developed the appropriate safety measures and contingency plans to ensure patients' safety in the whole process. Patients will be followed up after the end of the trial, and follow-up observations will be performed every month during the first year. Followed every 3 months in the second year for 3 years.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Vitamin C	Participants will receive intravenous vitamin C therapy at the indicated dose.
DRUG	Tyrosine kinase inhibitor	Participants will receive Tyrosine kinase inhibitor therapy in cycles: continuous treatment at the indicated dose.

Timeline

• Start date: 2018-12-05
• Primary completion: 2020-12-31
• Completion: 2022-12-31
• First posted: 2019-01-10
• Last updated: 2019-01-10

Locations

1 site across 1 country: China