Can a malaria drug help lung cancer patients stay ahead of resistance?
NCT ID NCT00977470
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding hydroxychloroquine (a malaria drug) to the targeted cancer pill erlotinib can delay drug resistance in people with advanced EGFR-mutant non-small cell lung cancer. About 76 participants will receive either erlotinib alone or erlotinib plus hydroxychloroquine. The goal is to see if the combination keeps the cancer from growing longer than erlotinib alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- erlotinib and hydroxychloroquine
- What this could lead to
- If it works, this could help people with EGFR-mutant lung cancer stay on effective treatment longer before their cancer becomes resistant.
- What could go wrong
- This is a small Phase 2 study, so results may not be definitive. Adding hydroxychloroquine could also increase side effects without improving outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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76 people
The number who actually took part.
- Start date
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Oct 2009
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Pathologically confirmed diagnosis of non-small cell lung cancer * Stage IV disease by the American Joint Committee on Cancer/IASLC 7th edition proposed edition staging criteria * An EGFR sensitizing mutation must be detected in tumor tissue. Specifically, patients harboring the most common mutations, deletions in exon 19 or the L858R mutation in exon 21 are eligible. Presence of the known resistance mutation T790M as detected by direct tumor sequencing is not allowed. Other rare EGFR mutations may be eligible after discussion with the overall principal investigator * Age equal to or greater than 18 years * Measurable disease by RECIST criteria, defined as the presence of at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as 10mm or greater with spiral CT scan * ECOG Performance status of 0, 1 or 2 * Since prior radiation or surgery, 14 days or more must have elapsed before starting protocol treatment * No prior treatment with erlotinib, gefitinib, or other small molecule EGFR-TKIs. Prior treatment in the adjuvant setting is allowed if at least 1 year has elapsed since TKI course. * Adequate organ function as outlined in the protocol * Patients must undergo a screening eye exam to obtain approval for HCQ treatment, which establishes the absence of baseline conditions include macular degeneration, visual field changes, other retinal disease, and cataracts that interfere with required funduscopic examinations * No G6PD deficiency, as HCQ may cause hemolysis in patients with G6DP Exclusion Criteria: * Symptomatic CNS metastases or newly diagnosed CNS metastases that have not yet been definitively treated with radiation and/or surgery. Note that patients with a history of CNS metastases or cord compression are allowed if they have been definitively treated and are clinically stable. Maintenance steroids are allowed but maintenance seizure medication with an EIAED is not allowed * Prior radiation therapy inclusive of all identified target lesions. Note that prior palliative radiation to bony disease, CNS disease, or a limited thoracic area is allowed, provided that there is measurable disease outside the field and radiation is completed at least two weeks prior to starting treatment and the patient has fully recovered from all side effects * Current use of hydroxychloroquine for any reason * Known hypersensitivity to chloroquine, hydroxychloroquine, or any closely related drug: erlotinib, gefitinib, or any closely related drug * Patients who are pregnant or breastfeeding. Female subjects of childbearing potential and male subjects must practice acceptable methods of birth control * Any evidence of clinically active interstitial lung disease. Note that patients with chronic, stable radiographic changes who are asymptomatic are eligible * Invasive malignancies within the past 3 years except for adequately treated carcinoma of the cervix, basal or squamous cell carcinomas of the skin * Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study, including a prior diagnosis of porphyria or non-light-sensitive psoriasis, as HCQ can significantly exacerbate both of these conditions * Use of any non-FDA approved or investigational agent in 30 days or less of enrolling onto the trial, or failure to recover from the side effects of any of these agents * Penicillamine use for Wilson's disease or any other indication, as concomitant use with HCQ can increase toxicity to penicillamine * Life expectancy of less than 12 weeks
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Stanford Cancer Institute
Stanford, California, 94305, United States
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University of Maryland
Baltimore, Maryland, 21201, United States
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Yale Cancer Center
New Haven, Connecticut, 06519, United States
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