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

NCT06267170 — Unknown, 288 participants, Henan Cancer Hospital

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

Registry	NCT06267170, acronym SCLC
Status	Unknown
Study type	Observational
Enrollment	288 (Estimated)
Sponsor	Henan Cancer Hospital (Other gov)
Conditions	SCLC,Extensive Stage
Interventions	Adebrelimab (Drug)
Dates	start 2024-02-25 (estimated), primary completion 2025-02-25 (estimated), completion 2026-02-25 (estimated), first posted 2024-02-20, last updated 2024-02-20

-Summary

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

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+Arms and interventions

Adebrelimab (Drug): Treatment with adbelizumab

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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.