Clinical trial · Interventional
Study of Oral Topotecan With Bevacizumab for Recurrent Small Cell Lung Cancer
An Open-label, Multicenter, Non-comparative, Phase II Study of Oral Topotecan in Combination With Bevacizumab for Second-line Treatment in Subjects With Relapsed Small-cell Lung Cancer (SCLC)
- 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)
Combination of Hycamtin (topotecan) and Avastin (bevacizumab) could allow killing of both endothelial and neoplastic cells. We postulate that addition of bevacizumab to topotecan will increase delivery of topotecan to tumor cells and may enhance activity of topotecan in patients with previously treated small cell lung cancer and improve progression free survival.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer, Small Cell | Lung Small Cell Carcinoma | ALIAS | 0.90 |
| Recurrent Small-cell Lung Cancer (SCLC) | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Open label, Single arm
- description
- Oral topotecan + IV Bevacizumab
- interventionNames
- Drug: Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab)
Primary outcomes (1)
- measure
- Percentage of Participants With Progression-free Survival (PFS) at 3 Months
- timeFrame
- 3 months
- description
- PFS = time from initiation of drug to time of first disease progression/death due to any cause. Progression assessed using Response Evaluation Criteria (RECIST): \>=20% increase in sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since treatment started, or appearance of new lesion(s). If participant did not progress or die, the time of initiation of post-treatment anti-cancer therapy or time of last contact used. PFS at 3 months calculated by taking the Kaplan-Meier (KM) estimate at 90 days from the initiation of treatment. SE = standard error.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of SCLC. * First recurrence of SCLC after therapy with one prior chemotherapy regimen at initial diagnosis. * Relapsed SCLC of any duration (both sensitive and resistant relapse). * ECOG performance status of \</= 2. * Adequate bone marrow reserve, hepatic, renal, and cardiovascular function. * No prior therapy with bevacizumab or any other VEGF inhibitor or topotecan Exclusion Criteria: * Uncontrolled emesis, regardless of etiology. * Active uncontrolled infection. * GI conditions or drugs that could impact absorption of oral topotecan. * Known hypersensitivity to any component of topotecan capsule or compounds chemically related to topotecan. * Uncontrolled hypertension with BP\>150/100. * Prior h/o hypertensive crisis or encephalopathy. * NYHA Grade II or greater congestive heart failure. * H/O myocardial infarction within 6 months. * H/O stroke or TIA within 6 months. * H/O thrombotic or hemorrhagic disorders. * Clinically significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months. * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days. * Anticipation of need for major surgical procedure during the study. * Minor surgical procedures within 7 days prior to treatment start (placement of vascular access devices is permitted). * H/O abdominal fistula, GI perforation, or intra-abdominal abscess within prior 6 months. Serious, non-healing wound, active ulcer, or untreated bone fracture. - H/O hemoptysis within prior 1 month. * Concurrent radiotherapy. * H/O whole lung radiation within 90 days prior to start of treatment. * Presence or h/o central nervous system or brain metastases. * H/o another malignancy other than SCLC. * Concurrent chemotherapy, immunotherapy, or investigational therapy for the treatment of small cell lung cancer.
References
Publications (1)
- DERIVEDSpigel DR, Waterhouse DM, Lane S, Legenne P, Bhatt K. Efficacy and safety of oral topotecan and bevacizumab combination as second-line treatment for relapsed small-cell lung cancer: an open-label multicenter single-arm phase II study. Clin Lung Cancer. 2013 Jul;14(4):356-63. doi: 10.1016/j.cllc.2012.12.003. Epub 2013 Feb 4. PMID 23391616