A Real-world Study of Adebrelimab Combined With Chemotherapy±Chest Radiotherapy in Patients With Extensive Stage Small Cell Lung Cancer

Extensive Stage Small Cell Lung Cancer Clinical Trial

Official title:

A Real-world Study of Adebrelimab Combined With Chemotherapy±Chest Radiotherapy in Patients With Extensive Stage Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06323265
• Other study ID #: ARL-SCLC-001
• Status: Recruiting
• Start date: March 26, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: March 2024
• Source: Hebei Medical University Fourth Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess efficacy and safety of patients who receive Adebrelimab combined with chemotherapy±chest radiotherapy as first-line treatment of extensive stage small cell lung cancer in the real world.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age:=18 years old;

2. Patients with extensive stage small cell lung cancer confirmed by histopathology;

3. Normal function of major organs;

4. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Exclusion Criteria:

1. Patients with drug allergy sufferers;

2. Serious and uncontrolled organic lesions or infections, such as decompensated heart, lung, kidney failure, etc;

3. History of psychiatric drugs abuse and can't quit or patients with mental disorders;

4. The researchers think inappropriate.

Related Conditions & MeSH terms

• Extensive Stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Adebrelimab + chemotherapy
Adebrelimab: 1200mg, d1, iv (30-60min), Q3W ,up to progressive disease or toxicity intolerable Chemotherapy: etoposide 100mg/m2,d1-3,iv;carboplatin AUC=5-6,d1,iv;or cisplatin 75mg/m2,d1,iv,Q3W,4 cycles;

Radiation:
• ±chest radiotherapy
Chest radiotherapy: 3Gy/15f-18f or 2Gy/20f-25f

Locations

Country	Name	City	State
China	Jun Wang	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Fourth Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)	Baseline to measured date of progression or death from any cause	evaluated in 24 months since the treatment began
Secondary	Objective response rate (ORR)	Baseline to measured stable disease	tumor assessment every 6 weeks since the treatment began,up to 24 months
Secondary	Disease control rate (DCR)	Baseline to measured progressive disease	tumor assessment every 6 weeks since the treatment began,up to 24 months
Secondary	Duration of Overall Response(DoR)	The duration of overall response is measured from the time that measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented	tumor assessment every 6 weeks since the treatment began,up to 24 months
Secondary	Overall survival (OS)	Baseline to measured date of death from any cause	the first day of treatment to death or last survival confirm date,up to 24 months
Secondary	Adverse events	Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. The number of Participants with adverse events will be recorded at each treatment visit	up to 24 months