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

March 26, 2024 updated by: Jun wang, Hebei Medical University Fourth Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • Jun Wang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

extensive stage small cell lung cancer

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: evaluated in 24 months since the treatment began
Baseline to measured date of progression or death from any cause
evaluated in 24 months since the treatment began

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: tumor assessment every 6 weeks since the treatment began，up to 24 months
Baseline to measured stable disease
tumor assessment every 6 weeks since the treatment began，up to 24 months
Overall survival (OS)
Time Frame: the first day of treatment to death or last survival confirm date,up to 24 months
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
Adverse events
Time Frame: up to 24 months
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
Disease control rate (DCR)
Time Frame: tumor assessment every 6 weeks since the treatment began，up to 24 months
Baseline to measured progressive disease
tumor assessment every 6 weeks since the treatment began，up to 24 months
Duration of Overall Response（DoR）
Time Frame: tumor assessment every 6 weeks since the treatment began，up to 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebei Medical University Fourth Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 14, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARL-SCLC-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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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