A Open-label Prospective Cohort Trial of Curcumin Plus Tyrosine Kinase Inhibitors (TKI) for EGFR -Mutant Advanced NSCLC

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lady Davis Institute
• Collaborator: Jewish General Hospital
• Treatments: Curcumin; Erlotinib Hydrochloride; Gefitinib

Criteria

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