Hydroxychloroquine and erlotinib in NSCLC.
Completed
- Conditions
- histologically confirmed stage IV non-squamous NSCLC patients who are eligible to start with EGFR targeted therapy1.patients who progressed on erlotinib or gefitinib monotherapy after having experienced an initial response.2.patients who failed chemotherapy after at least one line of platinum based doublet chemotherapy and who are EGFR TKI naïveDutch:Histologisch bewezen stadium IV non-squamous NSCLC patienten.• Patienten:• met een activerende EGFR mutatie die progressief zijn onder erlotinib of gefitinib monotherapie.OF• welke progressieve ziekte hebben na eerdere
- Registration Number
- NL-OMON21406
- Lead Sponsor
- VU University Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 136
Inclusion Criteria
1. Histologically confirmed stage IV non-squamous NSCLC patients;
2. Patients:
Exclusion Criteria
See inclusion criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the efficacy of HCQ and erlotinib treatment, as measured by a decrease in tumor 18F-FDG uptake after one week in two cohorts of NSCLC patients that are eligible for erlotinib therapy.
- Secondary Outcome Measures
Name Time Method 1. To assess the disease control rate (DCR) according to the response evaluation criteria in solid tumors (RECIST v1.1) with CT-Thorax, the performance free survival (PFS) at six months and the overall survival (OS) at one year;<br /><br>2. To assess the level of autophagy at baseline and to detect autophagy inhibition during treatment in peripheral blood and tumor samples (section 11);<br /><br>3. To analyze the relation between EGFR mutation status and response to hydroxychloroquine and erlotinib treatment;<br /><br>4. To assess toxicity of hydroxychloroquine according to CTC AE 4.0.