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

NCT06267170 | Not Yet Recruiting

• 1 other identifier: SCLC-RWS-001
• Study Type: observational
• Target: 288
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

SCLC,Extensive Stage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• PFS

  End of every two cycles (each cycle is 28 days)

• ORR

  End of every two cycles (each cycle is 28 days)

• OS

  End of every two cycles (each cycle is 28 days)

• DCR

  End of every two cycles (each cycle is 28 days)

Interventions

Adebrelimab DRUG

Treatment with adbelizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with extensive stage small cell lung cancer treated with adebrelimab

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 20, 2024
• Study Start: February 25, 2024
• Primary Completion: February 25, 2025
• Study Completion: February 25, 2026
• Last Updated: February 20, 2024

Record last verified: 2024-02