Clinical trial · Interventional
A Open-label Prospective Cohort Trial of Curcumin Plus Tyrosine Kinase Inhibitors (TKI) for EGFR -Mutant Advanced NSCLC
A Phase 1 Open-label Prospective Cohort Trial of Curcumin Plus Tyrosine Kinase Inhibitors for Epidermal Growth Factor Receptor (EGFR)-Mutant Advanced Non-small Cell Lung Cancer
NCT02321293CI-TRIAL-00019013CURCUMINunknownPhase 1ClinicalTrials.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)
The purpose of this study is is to assess the safety and tolerability of curcumin in combination with EGFR-TKIs in selected patients with advanced non-resectable mutant EGFR NSCLC.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CurcuVIVA™ | Dietary Supplement | — | UNRESOLVED |
| Tyrosine Kinase Inhibitor erlotinib (Tarceva) | Drug | — | UNRESOLVED |
| Tyrosine Kinase Inhibitor gefitinib (Iressa) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- CurcuVIVA™ (NPN 80027414) at a single dose of 80 mg PO daily without any dose escalation to be taken in conjunction with an EGFR-TKI therapy. CurcuVIVA™ is given in capsule forms. Unit strength of CurcuVIVA™ is equal to Turmeric Extract 25:1 348 mg (containing 80mg Longvida® Optimized Curcumin) Tyrosine Kinase Inhibitors: 1. Gefitinib is a targeted therapy, given in a capsule form once daily. The daily dose is 250 mg . 2. Erlotinib is a targeted therapy, given in a capsule form once daily. The daily dose is 150 mg . Study intervention is 8 weeks, following which the patients will continue taking their EGFR-TKI without curcumin until progression. The side effects of curcumin will be followed for another 8 weeks from the date of stopping curcumin.
- interventionNames
- Dietary Supplement: CurcuVIVA™
- Drug: Tyrosine Kinase Inhibitor gefitinib (Iressa)
- Drug: Tyrosine Kinase Inhibitor erlotinib (Tarceva)
Primary outcomes (5)
- measure
- feasibility assessed by: Willingness of patients to participate= Number of enrolled/Number of approached patients,
- timeFrame
- 8 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed or patients on treatment for histologically confirmed advanced EGFR-mutant NSCLC defined as unresectable stage 3A, stage 3B or stage 4. * The EGFR mutation analysis must be performed prior to enrolment into the trial (i.e., before a patient is consented). Any EGFR mutation-positive result must be documented and the analysis for the mutation will be performed using the JGH local testing methodology. * Receiving concurrent EGFR-TKI therapy. * Eastern Cooperative Oncology Group (ECOG) Performance Score 0-3 Exclusion Criteria: * Symptomatic brain metastases. * Patients who are receiving any other investigational agents. * Patients using other non-vitamin or mineral regular natural health product, which includes Chinese Herbs. * Incapacity to understand and sign a written informed consent document in English/French. * Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.