Clinical trial · Interventional
Bendamustine With Irinotecan Followed by Etoposide/Carboplatin for Patients With Extensive Stage Small Cell Lung Cancer
Phase I/IIa Study of the Novel Combination of Bendamustine With Irinotecan Followed by Etoposide/Carboplatin in Chemonaive Patients With Extensive Stage Small Cell Lung Cancer
- 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)
Small cell lung cancer, or SCLC, constitutes approximately 15% of the 170,000 new cases of lung cancer diagnosed annually in the United States. Extensive-stage SCLC comprises two thirds of new cases and is generally considered sensitive to chemotherapy, despite a median time to progression of 4 months. SCLC is one of the most aggressive and lethal types of cancer, with a median survival of 9 months (range 7-11 months) in patients diagnosed with extensive disease. Overall, the majority of patients with SCLC die in less than 2 years (2-year survival rates generally less than 10%), and the 5-year survival rate is 2.3% for patients with extensive disease. The regimen of etoposide in combination with a platinum (cisplatin or carboplatin) is generally considered the "standard of care" although a recent Phase III trial suggests improved survival with the combination of cisplatin/irinotecan. Further evaluation of new agents in combination regimens attempting to overcome the intrinsic drug resistance seen in extensive-stage SCLC is warranted attempting to improve survival and achieve palliation of disease-related symptoms.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemonaive | — | UNRESOLVED | — |
| Extensive Stage Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Novel Drug Combination | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Novel Drug Combination
- description
- This novel drug combination includes: Bendamustine, Irinotecan, and Etoposide/Carboplatin. This study has only one arm but it incorporates two phases. Phase I utilizes a combination of bendamustine and irinotecan for Regimen A followed by etoposide and carboplatin for Regimen B.
- interventionNames
- Drug: Novel Drug Combination
Primary outcomes (2)
- measure
- Number of Participants Experiencing Dose Limiting Toxicity Regimen A - Phase I
- timeFrame
- 9 weeks
- description
- The determination of the dose limiting toxicity as defined by The National Cancer Institute Common Toxicity Criteria version 3 as follows: grade 4 neutropenia \>5 days; grade 3/4 febrile neutropenia; grade 4 thrombocytopenia; or grade \>2 non-hematologic toxicities (except for nausea/vomiting, alopecia, or fatigue).
- measure
- Number of Patients With Adverse Events - Phase II
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytologic diagnosis of extensive stage SCLC. * Measurable or assessable tumor parameters. * ECOG Performance Status 0-2. * Age between 18 and 79 years (in the State of Alabama \> 18). * Adequate bone marrow, liver and renal function, defined as: * Absolute neutrophil count (ANC) ≥ 1500/µL * Hemoglobin ≥ 8g/dl * Platelet count ≥ 100,000/µL * SGOT/SGPT ≤ 2 x upper limit of normal or ≤ 5 x upper limit of normal when liver metastases are present. * Total bilirubin value ≤ 2 x upper limit of normal. * Serum creatinine value ≤ 2 x upper limit of normal. * Fully recovered from any previous surgery (at least 4 weeks since major surgery) * Must have recovered from prior radiation therapy (at least 3 weeks) * All subjects must agree to practice approved methods of birth control (if applicable). A negative pregnancy test must be documented during the screening period for women of childbearing potential. * Must provide written informed consent and authorization to use and disclose health information (HIPAA). * Extensive-stage SCLC as defined as disease not confined to one hemithorax, including ipsilateral pleural effusion or pericardial effusion. * No prior chemotherapy. Exclusion Criteria: * Concurrent cancer chemotherapy, biologic therapy or radiotherapy. * Administration of any investigational drug within 28 days prior to administration of the current therapy. * Symptomatic brain metastases; those patients should be treated first with either whole brain radiation therapy or radiosurgery. * Concurrent serious infection. * Concomitant severe or uncontrolled underlying medical disease unrelated to the tumor, which is likely to compromise patient safety and affect the outcome of the study. * History of other malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for a minimum of 2 years. * Neuropathy at baseline ≥ Grade 2. * Any evidence or history of hypersensitivity or other contraindications for the drugs used in this trial. * History of chronic diarrhea; or diarrhea (excess of 2-3 stools/day above normal frequency) in the past 2 weeks. * History of a positive serology for human immunodeficiency virus (HIV). * Psychiatric disorder that prevents patients from providing informed consent or following protocol instructions. * Pregnant or lactating women.
References
Publications (0)
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