Phase 2
Completed N=6
Sirolimus and Auranofin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer or Small Cell Lung Cancer
Extensive Stage Small Cell Lung Carcinoma · Lung Adenocarcinoma · Recurrent Non-Small Cell Lung Carcinoma · Recurrent Small Cell Lung Carcinoma
Source: ClinicalTrials.gov NCT01737502 ↗
Enrolled (actual)
6
Serious AEs
34.5%
Results posted
Aug 2025
Primary outcomePrimary: Number of Phase 1 Patients Experiencing a DLT — 0; 0 Participants
Summary
This phase I/II trial studies the side effects and best dose of auranofin when given together with sirolimus and to see how well it works in treating patients with lung cancer that has spread or other places in the body and cannot be cured or controlled by treatment or has come back after a period of time during which the cancer could not be detected. Auranofin and sirolimus may stop or slow the growth of lung cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Phase 1 Patients Experiencing a DLT |
0; 0 | — |
| PRIMARY Number Phase 1 Patients Experiencing a Grade 3+ AE |
2; 1 | — |
| PRIMARY Progression-free Survival Rate |
66.7; 28.0 | — |
| SECONDARY Overall Survival Time |
4.9; 8.6 | — |
| SECONDARY Progression-free Survival Time |
4.9; 2.1 | — |
| SECONDARY Number of Patients Achieving a Complete Response (CR) or Partial Response (PR) Noted as the Objective Status |
1; 2 | — |
| SECONDARY Duration of Response |
16.25 | — |
Eligibility Criteria
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 = = 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 = 40%
- Myocardial infarction = 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
Data sourced from ClinicalTrials.gov (NCT01737502). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.