Clinical trial · Interventional
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
NCT03799094CI-TRIAL-00036471unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tyrosine kinase inhibitor | Drug | Tyrosine Kinase Inhibitor | ALIAS |
| Vitamin C | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- 75 patients received a weekly intravenous Vitamin C injection (dose: 30 g / time, once a week, treatment termination when the disease progress is confirmed) in combination with daily taking tyrosine kinase inhibitor.
- interventionNames
- Drug: Vitamin C
- Drug: Tyrosine kinase inhibitor
- type
- EXPERIMENTAL
- label
- Control group
- description
- 75 patients received tyrosine kinase inhibitor daily. (dose: Osimertinib 80 mg/d, or Tarceva 150 mg/d, or Iressa 0.25 g/d.)
- interventionNames
- Drug: Tyrosine kinase inhibitor
Primary outcomes (1)
- measure
- Progression free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Primary non-small cell lung cancer (adenocarcinoma) with EGFR mutations on exons 19 and 21. * 18 years old to 75 years old. * During the trial, patients were prescribed TKI drugs(received initial treatment within 2 months, or change medication within 2 months) and did not receive chemotherapy or radiotherapy at the same time. * Eastern Cooperative Oncology Group (ECOG) performance status are 0 to 2. * Expected survival over 3 months. * Household registration is Guangdong Province. Exclusion Criteria: * Co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), and uncontrolled blood sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis. * Glucose-6-phosphate dehydrogenase deficiency (G6PD) (a relative contraindication). * Patients who are allergic to vitamin C. * Patients with HIV and other infectious diseases. * Patients who are taking anticoagulants and have coagulopathy; * Combine dysfunction of important organs such as heart, lung, liver and kidney; * Patients with impaired renal function (serum creatinine content \> 1.2 mg/dL) * Compromised liver function with evidence of Serum total bilirubin content, Serum alanine aminotransferase(ALT) and aspartate transaminase(AST)\> 2 times normal reference value. * Pregnant or lactating female. * Smoking and alcohol abuse patients; * Anti-infective treatment is required for systemic or localized serious infections; * Patients with hyperuricacidemia (normal: 91-456 μmol / 24h (8-40mg / 24h)); * Wilson's disease. * Evidence of significant psychiatric disorder by history or examination that would prevent completion of the study or preclude informed consent. * Any condition that impairs the patients' ability to swallow, which impairs drug absorption or drug kinetic parameters, including any kind of gastrointestinal resection or surgery; * History of surgery of visceral organs within 6 weeks before the study.
References
Publications (0)
Data not yet available
No reference posted for this study.