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

NCT06323265 | Recruiting

• 1 other identifier: ARL-SCLC-001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Extensive Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Baseline to measured date of progression or death from any cause

  evaluated in 24 months since the treatment began

Secondary Outcomes (5)

• Objective response rate (ORR)

  tumor assessment every 6 weeks since the treatment began，up to 24 months

• Disease control rate (DCR)

  tumor assessment every 6 weeks since the treatment began，up to 24 months

• Duration of Overall Response（DoR）

  tumor assessment every 6 weeks since the treatment began，up to 24 months

• Overall survival (OS)

  the first day of treatment to death or last survival confirm date,up to 24 months

• Adverse events

  up to 24 months

Study Arms (1)

Experimental

Drug: Adebrelimab + chemotherapy; Radiation: ±chest radiotherapy

Interventions

Adebrelimab + chemotherapy DRUG

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；

Experimental

±chest radiotherapy RADIATION

Chest radiotherapy: 3Gy/15f-18f or 2Gy/20f-25f

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

extensive stage small cell lung cancer

You may qualify if:

• Age:≥18 years old;
• Patients with extensive stage small cell lung cancer confirmed by histopathology;
• Normal function of major organs;
• Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

You may not qualify if:

• Patients with drug allergy sufferers;
• Serious and uncontrolled organic lesions or infections, such as decompensated heart, lung, kidney failure, etc;
• History of psychiatric drugs abuse and can't quit or patients with mental disorders;
• The researchers think inappropriate.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

Jun Wang

Shijiazhuang, Hebei, China

RECRUITING

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: March 26, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

CN (1)