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Intervention A: Irinotecan; Oxaliplatin; Neulasta · 1 trial · 1 indication
The primary objective is to determine the objective tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide/carboplatin in chemotherapy-naïve patients with extensive SCLC and Stage IIIb (wet) - IV Large Cell Carcinoma of the Lung with neuroendocrine markers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable response means did not meet criteria for progressive or partical response. 20% progressive disease.
The objective is to determine the objective tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide/carboplatin in chemotherapy-naïve patients with extensive SCLC and Stage IIIb (wet) - IV Large Cell Carcinoma of the Lung with neuroendocrine markers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable response means did not meet criteria for progressive or partical response. 20% progressive disease.
| Arm | Type | Description |
|---|---|---|
| Irinotecan; Oxaliplatin; Neulasta | EXPERIMENTAL | Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks) |
| Etoposide; Carboplatin; Neulasta | EXPERIMENTAL | Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) area under the concentration curve (AUC) 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks) |
| Name | Type | Description |
|---|---|---|
| Intervention A: Irinotecan; Oxaliplatin; Neulasta | DRUG | Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks) |
| Intervention B: Etoposide; Carboplatin; Neulasta | DRUG | Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks) |
Inclusion Criteria: 1. Histologic or cytologic diagnosis of SCLC. 2. Measurable or assessable tumor parameters. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. 4. Age between 18 and 79 years (in the State of Alabama \> 18). 5. Adequate bone marrow, liver and renal function, def...
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Intervention A: Irinotecan; Oxaliplatin; Neulasta is a combination of drugs being studied for the treatment of Non-Small Cell Lung Cancer. It is an investigational regimen in Phase 2 clinical development, evaluated in a completed trial with 30 participants in the United States.
The regimen combines irinotecan and oxaliplatin, which are chemotherapy agents that target rapidly dividing cancer cells by interfering with DNA replication, along with Neulasta (pegfilgrastim), a supportive therapy that stimulates white blood cell production to reduce infection risk during chemotherapy.
Intervention A: Irinotecan; Oxaliplatin; Neulasta is developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. Amgen is the developer of this combination regimen for Non-Small Cell Lung Cancer.
Intervention A: Irinotecan; Oxaliplatin; Neulasta is in Phase 2 clinical development. It is an investigational regimen, not yet approved, and has completed one Phase 2 trial with 30 participants. The trial was controlled but not randomized or double-blinded.
Intervention A: Irinotecan; Oxaliplatin; Neulasta has one completed clinical trial, NCT00240097, titled 'Study of Sequential Topoisomerase, Irinotecan/Oxaliplatin - Etoposide /Carboplatin in Extensive Small Cell Lung Cancer (SCLC)'. This Phase 2 trial enrolled 30 adults in the United States and included biomarker selection.