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NCT00977470 · ClinicalTrials.gov registry record · Phase 2
Erlotinib With or Without Hydroxychloroquine in Chemo-Naive Advanced NSCLC and (EGFR) Mutations
A Phase 2 study of Non-Small Cell Lung Cancer, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
- 4
- Study locations
NCT00977470: Active Phase 2 study of Non-Small Cell Lung Cancer, sponsored by Massachusetts General Hospital.
NCT00977470 is a Phase 2 study of Non-Small Cell Lung Cancer that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 76 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (88% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00977470, a Phase 2 study of Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this research study is to learn if adding hydroxychloroquine (HCQ) to erlotinib helps treat non-small cell lung cancer (NSCLC). Another goal of this research study is to learn more about NSCLC and how it may respond to study treatment. Erlotinib (Tarceva) is a type of drug called a tyrosine kinase inhibitor (TKI). TKIs block a protein called the epidermal growth factor receptor (EGFR). EGFR may control tumor growth and tumor cell survival. However, although TKI drugs can work for some lung cancer patients for a period of time, eventually the tumor finds a way to resist or counteract the TKI treatment and it begins to grow again. Hydroxychloroquine (HCQ) is a drug approved by the FDA for treating malaria, rheumatoid arthritis, and several other diseases. Laboratory research suggests that when HCQ is given with a TKI, it may help delay or prevent TKI resistance from developing.
Primary Outcome
A measure of progression-free survival in patients with advanced non small-cell lung cancer (NSCLC) and EGFR mutations treated with erlotinib as compared with patients treated with erlotinib plus hydroxychloroquine (HCQ). Disease progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, as seen on CT scan, or the appearance of one or more new lesions on CT scan.
Conditions Studied
Interventions
- DRUG Hydroxychloroquine
- DRUG Erlotinib
Study Locations (4)
California
- Stanford Cancer Institute - Stanford
Connecticut
- Yale Cancer Center - New Haven
Maryland
- University of Maryland - Baltimore
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2009-10 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What the registry record for NCT00977470 still lists
NCT00977470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Hydroxychloroquine is the first listed.
NCT00977470 reports a single indexed study location in California, Connecticut, Maryland.
Frequently Asked Questions
What is clinical trial NCT00977470 about?
NCT00977470 is a clinical study titled "Erlotinib With or Without Hydroxychloroquine in Chemo-Naive Advanced NSCLC and (EGFR) Mutations". The purpose of this research study is to learn if adding hydroxychloroquine (HCQ) to erlotinib helps treat non-small cell lung cancer (NSCLC). Another goal of this research study is to learn more about NSCLC and how it may respond to study treatment. Erlotinib (Tarceva) is a type of drug called a ty...
What is the current status of trial NCT00977470?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2009-10. Estimated completion is 2027-12.
What conditions does trial NCT00977470 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT00977470?
The interventions under investigation include: Hydroxychloroquine (DRUG), Erlotinib (DRUG).
Who is sponsoring clinical trial NCT00977470?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00977470 being conducted?
This trial has 4 study locations across California, Connecticut, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00977470's enrollment target sits among peer trials
76 274th of 454 higher than 177 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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