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

A Multicenter, Real-world Study of Adebrelimab in the Treatment of Extensive Stage

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

Study Overview

• Status: Not yet recruiting
• Conditions: SCLC,Extensive Stage
• Intervention / Treatment: Drug: Adebrelimab

• Study Type: Observational
• Enrollment (Estimated): 288

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with extensive stage small cell lung cancer treated with adebrelimab

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety (Occurrence of ≥ Grade 3 AE)	The incidence of grade 3 or higher adverse events	End of each cycle (each cycle is 28 days)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 25, 2024
• Primary Completion (Estimated): February 25, 2025
• Study Completion (Estimated): February 25, 2026

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 18, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SCLC-RWS-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No