A Multicenter, Real-world Study of Adebrelimab in the Treatment of Extensive Stage Small Cell Lung Cancer

Not yet recruiting

• Conditions: SCLC,Extensive Stage

• Registration Number: NCT06267170
• Lead Sponsor: Henan Cancer Hospital

Brief Summary

This study collected data on patients with extensive stage small cell lung cancer treated with Adebrelimab to investigate its safety and efficacy

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-30
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-18
• Last Update Submitted: 2024-02-18
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20
• Study Start: 2024-02-25
• Primary Completion: 2025-02-25
• Study Completion: 2026-02-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

1. Sign informed consent and join the study voluntarily;
2. Patients diagnosed with extensive small cell lung cancer;
3. Age ≥18 years old;
4. Have at least one measurable lesion (according to RECIST 1.1);
5. The investigators judged that adebrelimab treatment was acceptable;
6. Contraception: Patients should agree that it must be used during the study period and within 6 months after the study ends Effective contraception;

Exclusion Criteria

1. Allergic to adebrelimab and its excipients;
2. Patients who have also received other immune drugs or therapies;
3. Patients who are participating in other interventional studies;
4. patients with other malignant tumors;
5. Pregnant or lactating women;
6. The investigator considers that the patient is not suitable to participate in any other conditions of the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety (Occurrence of ≥ Grade 3 AE)	End of each cycle (each cycle is 28 days)	The incidence of grade 3 or higher adverse events

Secondary Outcome Measures

Name	Time	Method
PFS	End of every two cycles (each cycle is 28 days)	Progression free survival
ORR	End of every two cycles (each cycle is 28 days)	Objective response rate
OS	End of every two cycles (each cycle is 28 days)	Overall survival
DCR	End of every two cycles (each cycle is 28 days)	Disease control rate