Clinical trial · Observational
Vinorelbine and Ifosfamide as Third-line Treatment for Refractory Small Cell Lung Cancer
A Phase Ⅱ Single-arm Clinical Trial to Investigate the Efficacy and Safety of Vinorelbine-ifosfamide Regimen as Third-line Treatment in Refractory or Recurrent Extensive Small Cell Lung Cancer Patients
- 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)
Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and etoposide(CE)and second-line therapy with topotecan has been given, patients with ED-SCLC still relapse and 2-year survival is less than 10%. There is no standard treatment recommendation for this group of patients who failed to second-line therapy and had good performance status. Some cytotoxic drugs for the treatment of non-small cell lung cancer, i.e. vinorelbine, paclitaxel, and ifosfamide, were used in refractory or recurrent SCLC patients. Recently, a retrospective study showed the overall response rate was 30%, the median progression free survival (PFS) was 6.5 months, and the median overall survival was 10.4 months in advanced combined SCLC patients treated with first-line regimen of vinorelbine, ifosfamide and cisplatin (NIP). Because of the previous platinum administration and patient's performance status, only vinorelbine and ifosfamide (NI) are combined and used as third-line therapy for refractor or recurrent ED-SCLC in our lung cancer center. And this clinical trial is designed to prospectively investigate the efficacy and safety of NI regimen in refractory or recurrent ED-SCLC patients in our center.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NI group | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- refractory SCLC
- description
- NI group vinorelbine 25mg/m2 d1,d8; Ifosfamide 1.25g/m2 d1-d3; Mesna 400mg iv 0,4,8 hours after ifosfamide administration for 3 days; every 3 weeks; up to the maximum cycles (total:6);
- interventionNames
- Drug: NI group
Primary outcomes (1)
- measure
- the disease control rate
- timeFrame
- up to 9 weeks
- description
- The disease control rate includes the rate of progression disease,partial remission and stable disease.
Secondary outcomes (4)
- measure
- progression free survival
- timeFrame
- up to 52 weeks (about one year)
- description
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * histologically or cytologically confirmed ED-SCLC; * age\>18 and \<75; * measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST); * previous treatments including first-line therapy with EP or CE and second-line therapy with topotecan; * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; * life expectancy \> 3 months; * neutrophil count \> 1500/ul; * platelet count \> 100,000ul; * hemoglobin level \> 9g/dl; * bilirubin level \< 1.5mg/dL; * creatinine level \< 2mg/dl; * alanine transaminase (AST) levels \< 2.5× upper limit of normal (ULN)(or \< 5× ULN if liver metastases were present); Exclusion Criteria: * previous anticancer therapy including vinorelbine or ifosfamide; * newly diagnosed central nervous system (CNS) metastasis and not treated by radiotherapy or surgery; * additional malignancies; * uncontrolled systemic disease; * pregnancy or breast feeding phase;
References
Publications (9)
- RESULTJackman DM, Johnson BE. Small-cell lung cancer. Lancet. 2005 Oct 15-21;366(9494):1385-96. doi: 10.1016/S0140-6736(05)67569-1. PMID 16226617
- RESULTSimon GR, Turrisi A; American College of Chest Physicians. Management of small cell lung cancer: ACCP evidence-based clinical practice guidelines (2nd edition). Chest. 2007 Sep;132(3 Suppl):324S-339S. doi: 10.1378/chest.07-1385. PMID 17873178
- RESULTClark R, Ihde DC. Small-cell lung cancer: treatment progress and prospects. Oncology (Williston Park). 1998 May;12(5):647-58; discussion 661-3. PMID 9597676
- RESULTFukuoka M, Furuse K, Saijo N, Nishiwaki Y, Ikegami H, Tamura T, Shimoyama M, Suemasu K. Randomized trial of cyclophosphamide, doxorubicin, and vincristine versus cisplatin and etoposide versus alternation of these regimens in small-cell lung cancer. J Natl Cancer Inst. 1991 Jun 19;83(12):855-61. doi: 10.1093/jnci/83.12.855. PMID 1648142
- RESULTWolf M, Havemann K, Holle R, Gropp C, Drings P, Hans K, Schroeder M, Heim M, Dommes M, Mende S, et al. Cisplatin/etoposide versus ifosfamide/etoposide combination chemotherapy in small-cell lung cancer: a multicenter German randomized trial. J Clin Oncol. 1987 Dec;5(12):1880-9. doi: 10.1200/JCO.1987.5.12.1880. PMID 2824710
- RESULTRoth BJ, Johnson DH, Einhorn LH, Schacter LP, Cherng NC, Cohen HJ, Crawford J, Randolph JA, Goodlow JL, Broun GO, et al. Randomized study of cyclophosphamide, doxorubicin, and vincristine versus etoposide and cisplatin versus alternation of these two regimens in extensive small-cell lung cancer: a phase III trial of the Southeastern Cancer Study Group. J Clin Oncol. 1992 Feb;10(2):282-91. doi: 10.1200/JCO.1992.10.2.282. PMID 1310103
- RESULTSkarlos DV, Samantas E, Kosmidis P, Fountzilas G, Angelidou M, Palamidas P, Mylonakis N, Provata A, Papadakis E, Klouvas G, et al. Randomized comparison of etoposide-cisplatin vs. etoposide-carboplatin and irradiation in small-cell lung cancer. A Hellenic Co-operative Oncology Group study. Ann Oncol. 1994 Sep;5(7):601-7. doi: 10.1093/oxfordjournals.annonc.a058931.