Old arthritis drug paired with immune suppressant shows promise against tough lung cancers
NCT ID NCT01737502
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested two drugs—auranofin (originally for arthritis) and sirolimus (an immune suppressant)—in 29 people with advanced or recurrent lung cancer who had no standard options left. The goal was to find the safest dose and see if the combination could slow cancer growth. The trial is now complete, but results are not yet widely available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- auranofin and sirolimus
- What this could lead to
- If it works, this could point toward a new treatment option for advanced lung cancer patients who have run out of standard therapies.
- What could go wrong
- This was a small, early-phase trial with only 29 participants, so results may not apply to all patients. The combination may cause significant side effects and may not effectively control the cancer.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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29 people
The number who actually took part.
- Started
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May 2014
- Finished
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Apr 2023
- Lead sponsor
-
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
-
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: * Histologic or cytologic confirmation of lung cancer (squamous, ras-mutated adenocarcinoma or small cell lung cancer) * Patients must have received at least one course of chemotherapy consisting of a platinum doublet and must have no acceptable standard treatment options * Prior radiation therapy is permitted as long as: * Recovered from the toxic effects of radiation treatment before study entry, except for alopecia * Absolute neutrophil count (ANC) \>= 1500 uL * Platelets (PLT) \>= 100,000 uL * Hemoglobin (Hgb) \>= 9 g/dL * Total bilirubin =\< 1.5 x upper limit of normal (ULN) or direct bilirubin =\< ULN * Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 3 x ULN or SGOT (AST) and SGPT (ALT) =\< 5 x ULN is acceptable if liver has tumor involvement * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 * Negative serum pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only * Ability to provide informed consent * Life expectancy \>= 12 weeks * Willing to return to Mayo Clinic enrolling institution for follow-up * Willing to provide tissue samples for correlative research purposes Exclusion Criteria: * Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception * Symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases or seizure disorder; NOTE: patients with treated CNS metastases without evidence of progression and without uncontrolled symptoms or need for steroids may enroll * Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded * Unwilling or unable to, comply with the protocol * Any of the following prior therapies: * Radiation to \>= 25% of bone marrow * Major surgery (i.e., laparotomy), open biopsy, or significant traumatic injury =\< 4 weeks prior to registration; minor surgery =\< 2 weeks prior to registration; insertion of a vascular access device is not considered major or minor surgery in this regard * Any of the following concurrent severe and/or uncontrolled medical conditions: * Hypertension, labile hypertension, or history of poor compliance with antihypertensive medication * Angina pectoris * History of congestive heart failure =\< 3 months, unless ejection fraction \> 40% * Myocardial infarction =\< 6 months prior to registration * Cardiac arrhythmia * Poorly controlled diabetes * Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung * Active or recent history of hemoptysis; if hemoptysis has resolved with measures such as palliative radiation therapy (e.g. 3000 cGy over 10 fractions), arteriographic embolization or endobronchial interventions (e.g. photodynamic therapy, brachytherapy), etc. for \> 14 days, patients may be considered for participation in this study * \>= Grade 2 hypertriglyceridemia * \>= Grade 2 hypercholesterolemia * Any illness that in the opinion of the investigator would compromise the ability of the patient to participate safely in the clinical trial * Use of St. John's Wort because of its effects on hepatic drug metabolism * Other active malignancy: EXCEPTIONS: Non-melanoma skin cancer, localized prostate cancer, or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior malignancy, patient must not be receiving other cytotoxic or molecularly targeted therapeutics treatment for their cancer; patients receiving certain hormonal manipulations as part of their treatment may be allowed to continue at the discretion of the Principal Investigator (PI) (e.g. luteinizing hormone-releasing hormone \[LHRH\] analogs for prostate cancer) * Unable to discontinue use of potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors/inducers
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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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Mayo Clinic
Jacksonville, Florida, 32224, United States
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Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
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