Erlotinib With or Without Hydroxychloroquine in Chemo-Naive Advanced NSCLC and (EGFR) Mutations

Part of paid clinical trials in Stanford, California.

Sponsor
Massachusetts General Hospital
Study ID
NCT00977470
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    150 mg taken orally once daily
  • Hydroxychloroquine — DRUG
    1000 mg taken orally once daily after erlotinib

Study Details

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.

Key Dates

First listed
Sep 15, 2009
Start date
Oct 31, 2009
Status verified
Sep 2025
Primary completion
May 31, 2015
Completion
Dec 31, 2027

Study Design

Enrollment
76 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib
    Erlotinib 150 mg oral daily
  • Experimental: Erlotinib and Hydroxychloroquine
    Erlotinib 150 mg oral daily plus Hydroxychloroquine (HCQ) 1000 mg oral daily

Primary Outcome Measure

Median Progression Free Survival [ Time Frame: From start of treatment until report of disease progression, assessed up to 10 years. ]

Locations (4)

FacilityCityStateZIPSite coordinators
Stanford Cancer InstituteStanfordCalifornia94305-
Yale Cancer CenterNew HavenConnecticut06519-
University of MarylandBaltimoreMaryland21201-
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Stanford, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Stanford Cancer Institute· Stanford, CAYale Cancer Center· New Haven, CTUniversity of Maryland· Baltimore, MDMassachusetts General Hospital· Boston, MA

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