assignment
Not Yet Recruiting

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

location_city
10
research sites
public
3
countries
medical_information
1
disease
person_search
9
investigators

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

Please provide the source data containing the names, forms, dosages, and administration details of the medications. The current request contains empty brackets for the **Products** section, which prevents the generation of the required technical description.

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 DenmarkNot Yet Recruiting01 May 202610
Poland PolandNot Yet Recruiting01 May 202610
Spain SpainNot Yet Recruiting01 May 202610

Sites & Investigators

Conditions Studied in This Trial