A Phase II Study of IBI3009 Monotherapy or in Combination with Combination Therapy in Patients with Extensive-Stage Small Cell Lung Cancer
- Trial ID
- 2025-523972-21-00
- Protocol
- CIBI3009A101
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the efficacy of IBI3009, administered as a monotherapy or in combination with other therapeutic regimens, in patients diagnosed with extensive-stage small cell lung cancer. Assessing these treatment modalities is clinically significant for determining improved survival outcomes and therapeutic responses in this advanced malignancy. 5
Participants
The study population consists of 60 patients diagnosed with extensive-stage small cell lung cancer. The cohort includes both male and female participants. Individuals within the study are categorized under vulnerable populations. Specific age demographics are defined by the inclusion of age range codes 3 and 4.
Plans and Procedures
This study evaluates the efficacy and safety of IBI3009 administered as a monotherapy or in combination with other therapeutic modalities for the treatment of extensive-stage small cell lung cancer. The research methodology utilizes a clinical trial design to assess these intervention strategies. The sequence of procedures begins with a screening visit to determine eligibility based on predefined criteria. Following successful screening, participants proceed through scheduled follow-up visits to monitor clinical progress and safety outcomes. The process concludes with an end-of-study visit. The total duration of the clinical trial is estimated to span from May 2026 to January 2029. Early termination of participation may occur according to established protocol conditions.
Treatment
Efficacy
The assessment of efficacy in this clinical trial for extensive-stage small cell lung cancer is not specified in the provided documentation.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
Denmark | Not Yet Recruiting | 01 May 2026 | 10 |
Poland | Not Yet Recruiting | 01 May 2026 | 10 |
Spain | Not Yet Recruiting | 01 May 2026 | 10 |



