Clinical trial · Interventional
Combined Simvastatin and Irinotecan in Treating ES-SCLC Patients Relapsed From 1st Chemotherapy
Clinical Study of Irinotecan With or Without Simvastatin in Treating Extensive-Stage Small Cell Lung Cancer Patients Relapsed From First-line Chemotherapy
NCT04985201CI-TRIAL-00053153unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 II study was designed to evaluate the safety and efficacy of irinotecan in combination with simvastatin compared with treatment with irinotecan alone in ES-SCLC patients relapsed from first-line chemotherapy. Participants will be divided in a 1:1 ratio to receive either irinotecan (4 cycles) + simvastatin (10 months) or irinotecan (4 cycles) until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan | Drug | Irinotecan | ALIAS |
| Simvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Simvastatin + Irinotecan
- description
- received intravenous infusions of Irinotecan 60 milligrams per square meter (mg/m\^2) on Day 1,8 of every 21-day cycle (4 cycles) in combination with oral simvastatin (20mg daily) (10 months)
- interventionNames
- Drug: Irinotecan
- Drug: Simvastatin
- type
- ACTIVE_COMPARATOR
- label
- Irinotecan
- description
- received intravenous infusions of Irinotecan 60 milligrams per square meter (mg/m\^2) on Day 1,8 of every 21-day cycle (4 cycles)
- interventionNames
- Drug: Irinotecan
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Patients must be volunteered to participate in the clinical trial. Patients must sign the informed Consent form (ICF) and be willing to follow and be able to complete all test procedures. Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system). No patients with resectable or radical radiotherapy lung cancer. Patient must have no Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic lymphoma kinase (ALK) rearrangement, or ROS proto-oncogene 1 , receptor tyrosine kinase(ROS1) rearrangement. Patient must be at least resistant to the first-line chemotherapy. Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Patients can tolerate chemotherapy. Exclusion Criteria: Unclear diagnosis of SCLC. Resectable or radical radiotherapy SCLC. Contraindicated chemotherapy. Undergoing other active malignancies within 5 years or at the same time.Patients with localized curable tumors, such as basal cell carcinoma, squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ, will not be excluded. Positive test result for human immunodeficiency virus (HIV). Positive test result for active tuberculosis. Live vaccine was administered within 28 days of initial administration. Inactivated viral vaccines for seasonal influenza are allowed, except for live attenuated intranasal vaccines. Pregnant or lactating women. A history of psychotropic substance abuse, drug abuse, or alcoholism. Other factors assessed by the sponsors.
References
Publications (5)
- RESULTGoldman JW, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Ozguroglu M, Ji JH, Garassino MC, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Kazarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Thiyagarajah P, Jiang H, Paz-Ares L; CASPIAN investigators. Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2021 Jan;22(1):51-65. doi: 10.1016/S1470-2045(20)30539-8. Epub 2020 Dec 4. PMID 33285097
- RESULTGelsomino F, Tiseo M, Barbieri F, Riccardi F, Cavanna L, Frassoldati A, Delmonte A, Longo L, Dazzi C, Cinieri S, Colantonio I, Sperandi F, Lamberti G, Brocchi S, Tofani L, Boni L, Ardizzoni A. Phase 2 study of NAB-paclitaxel in SensiTivE and refractory relapsed small cell lung cancer (SCLC) (NABSTER TRIAL). Br J Cancer. 2020 Jul;123(1):26-32. doi: 10.1038/s41416-020-0845-3. Epub 2020 Apr 29. PMID 32346071
- RESULTChen Y, Li X, Zhang R, Xia Y, Shao Z, Mei Z. Effects of statin exposure and lung cancer survival: A meta-analysis of observational studies. Pharmacol Res. 2019 Mar;141:357-365. doi: 10.1016/j.phrs.2019.01.016. Epub 2019 Jan 11. PMID 30641276
- RESULTKhanzada UK, Pardo OE, Meier C, Downward J, Seckl MJ, Arcaro A. Potent inhibition of small-cell lung cancer cell growth by simvastatin reveals selective functions of Ras isoforms in growth factor signalling. Oncogene. 2006 Feb 9;25(6):877-87. doi: 10.1038/sj.onc.1209117. PMID 16170339
- RESULTHolstein SA, Hohl RJ. Synergistic interaction of lovastatin and paclitaxel in human cancer cells. Mol Cancer Ther. 2001 Dec;1(2):141-9. PMID 12467231