Hydroxychloroquine With or Without Erlotinib in Advanced Non-small Cell Lung Cancer (NSCLC)
Erlotinib is a type of drug called a tyrosine kinase inhibitor (TKI). TKIs block a protein called epidermal growth factor receptor (EGFR). EGFR may control tumor growth and tumor cell survival. EGFR is found on the surface of many types of cancer cells, including non-small cell lung cancer (NSCLC). Erlotinib is approved by the Food and Drug Administration (FDA) for the treatment of NSCLC. Hydroxychloroquine (HCQ) is a drug approved by the FDA for treatment of malaria, rheumatoid arthritis, and several other diseases but is not currently thought of as a cancer treatment. Previous laboratory studies suggests that HCQ may have an anti-cancer effect by itself in some situations, particularly when EGFR TKI drugs have been useful in the past against the tumor. The two drugs together may be able to fight lung cancer in cases where erlotinib is no longer effective by itself. The purpose of this research study is to determine the highest dose of HCQ that can be given safely in combination with erlotinib. We will also begin to look at whether HCQ plus erlotinib helps treat cancer that have become resistant to TKI treatment after initially responding.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jan 30, 2017 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Massachusetts General Hospital
- Interventions being studied
- Drug: erlotinib; Drug: hydroxychloroquine
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Pathologically confirmed diagnosis of non-small cell lung cancer
- Stage IIIB with pleural effusion or Stage IV disease by the American Joint Committee on Cancer (AJCC) 6th edition staging criteria.
- At least 12 weeks of prior treatment with erlotinib, gefitinib, or another EGFR small molecule TKI agent.
- Age equal to or greater than 18 years
- Measurable disease, defined according to RECIST criteria
- Performance status of 0, 1 or 2
- At least 2 weeks since prior radiation treatment
- At least 2 weeks since any prior chemotherapy or targeted therapy
- Adequate organ function as outlined in the protocol
- Approval for HCQ treatment by an eye doctor, based on a screening eye exam. Examples of disqualifying baseline conditions include macular degeneration and other retinal disease.
- Willingness to comply with protocol procedures including the blood-sampling schedule for PK analyses and periodic eye examination
- Current use of hydroxychloroquine for any reason
- Known hypersensitivity to chloroquine, hydroxychloroquine, or any other closely related drug
- Known hypersensitivity to erlotinib, gefitinib, or any closely related drug
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency, as HCQ may cause hemolytic anemia in patients with G6PD deficiency
- Cataracts that would interfere with required funduscopic examinations, or severe baseline visual impairment including macular degeneration, retinopathy or visual field changes, or having only one functional eye. All patients must undergo a screening eye exam prior to enrollment
- Pregnancy or breastfeeding. Female subjects of childbearing age and male subjects must practice acceptable method of birth control
- Symptomatic CNS metastases or newly diagnosed CNS metastases that have not yet been definitively treated with radiation and/or surgery
- Prior radiation therapy inclusive of all identified target lesions
- Any evidence of clinically active interstitial lung disease
- Malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
- Although not an absolute
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Massachusetts General HospitalBoston, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 30, 2017. Always confirm current availability with the study team.