Clinical trial · Interventional
Sirolimus and Auranofin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer or Small Cell Lung Cancer
A Phase I-II Trial of Combined PKCι and mTOR Inhibition for Patients With Advanced or Recurrent Lung Cancer (NSCLC and SCLC) Without Standard Treatment Options
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extensive Stage Small Cell Lung Carcinoma | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Lung Adenocarcinoma | Lung Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Non-Small Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Small Cell Lung Carcinoma | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Squamous Cell Lung Carcinoma | Lung Squamous Cell Carcinoma | ALIAS | 0.90 |
| Stage IIIA Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIIB Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Auranofin | Drug | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Pharmacological Study | Other | — | UNRESOLVED |
| Sirolimus | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (auranofin and sirolimus)
- description
- Patients receive auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Auranofin
- Drug: Sirolimus
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Study
Primary outcomes (3)
- measure
- Number of Phase 1 Patients Experiencing a DLT
- timeFrame
- 28 days
- description
- The number and severity of all adverse events (overall and by dose level) will be tabulated and summarized. A DLT is defined as an adverse event during the first cycle of, at least possibly related to study treatment, and one of the following: Grade 4 Neutropenia, Grade 4 Thrombocytopenia, ≥Grade 3 Anaphylaxis, ≥Grade 3 Proteinuria, ≥Grade 3 Hematuria, ≥Grade 3 Rash acneiform, ≥Grade 3 Diarrhea, ≥Grade 3 Mucositis oral
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDJatoi A, Foster NR, Wahner Hendrickson A, Block MS, Weroha SJ, Asmus EJ, Murray NR, Fields AP. A Phase 2 Trial of Protein Kinase C Iota Inhibition With the Combination of Auranofin and Sirolimus in Patients With Recurrent Ovarian Cancer. Am J Clin Oncol. 2026 May 1;49(5):238-242. doi: 10.1097/COC.0000000000001263. Epub 2025 Oct 20. PMID 41114938
- DERIVEDRousselle B, Massot A, Privat M, Dondaine L, Trommenschlager A, Bouyer F, Bayardon J, Ghiringhelli F, Bettaieb A, Goze C, Paul C, Malacea-Kabbara R, Bodio E. Conception and Evaluation of Fluorescent Phosphine-Gold Complexes: From Synthesis to in vivo Investigations. ChemMedChem. 2022 Jun 3;17(11):e202100773. doi: 10.1002/cmdc.202100773. Epub 2022 Mar 29. PMID 35254001