Clinical TrialID 8204
Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy
NCT05815160
Small Cell Lung Cancer Recurrent
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 8204
- Evidence Id
- 8204
- Core Evidence Id
- 8204
- Source Clinical Trial Id
- 8202
- Herb2 Clinical Trial Id
- HBCT008202
- Nct Id
- NCT05815160
- Title
- Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy
- Status
- Recruiting
- Phase
- Phase 1
- Study Result
- No
- Study Condition
- Small Cell Lung Cancer Recurrent
- Study Type
- Interventional
- Study Design
- Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: Debio 0123|DRUG: Etoposide|DRUG: Carboplatin
- Intervention Allocation
- Non_Randomized
- Intervention Model
- Sequential
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 78
- Outcome Measure
- Part 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs), Cycle 1 (Cycle=21 days)|Parts 1 and 2: Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE), Approximately up to 44 months|Parts 1 and 2: Number of Participants With Clinically Significant Abnormalities in Laboratory, Vital Signs, Electrocardiogram (ECG), and Echocardiogram Parameters, Approximately up to 44 months|Parts 1 and 2: Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS), Baseline up to approximately 44 months
- Sponsor Collaborator
- Debiopharm International SA
- Funded By
- INDUSTRY
- Location
- University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States|Henry Ford Health System, Detroit, Michigan, 48202, United States|Roswell Park Comprehensive Cancer Center, Buffalo, New York, 14263, United States|Hospital Universitario Vall d'Hebron, Barcelona, 08035, Spain|Hospital Clinic Barcelona, Barcelona, 08036, Spain|Institut Catala D'Oncologia - Badalona, Barcelona, 08908, Spain|Hospital Universitario de A Coruna, Coruña, 15006, Spain|Hospital General Universitario Gregorio Maranon, Madrid, 28007, Spain|Clinica Universidad de Navarra, Madrid, 28027, Spain|Hospital Universitario 12 de Octubre, Madrid, 28041, Spain|Hospital Universitario HM Sanchinarro. START Madrid - Centro Integral Oncológico Clara Campal (CIOCC), Madrid, 28050, Spain|NEXT Oncology Madrid,, Madrid, 28223, Spain|Hospital Quironsalud Malaga, Málaga, 29004, Spain|Clinica Universidad de Navarra, Pamplona, 31008, Spain|Hospital Clinico Universitario de Valencia, Valencia, 46010, Spain
- Other Id
- Debio 0123-SCLC-104|2022-001976-32
- Start Date
- 2023-05-02
- Primary Completion Date
- 2026-01
- Completion Date
- 2026-04
- First Posted
- 2023-04-18
- Results First Posted
- Last Update Posted
- 2024-09-27
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05815160
- Title Cn
- Title En
- Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy
- Bilingual Status
- semi_complete