CClinicalTrials.gg
RecruitingNCT06323265Updated Mar 27, 2024

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

An observational study in Extensive Stage Small Cell Lung Cancer, sponsored by Hebei Medical University Fourth Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-27.

Sponsored by Hebei Medical University Fourth Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 6 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Extensive Stage Small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

This study's planned enrollment of 50 is below the median of 189 across 1,512 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Hebei Medical University Fourth Hospital is the lead sponsor of 78 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

extensive stage small cell lung cancer

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Experimental

    Drug: Adebrelimab + chemotherapy · Radiation: ±chest radiotherapy

Interventions

  • DrugAdebrelimab + 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

06

What researchers measure

Primary outcomes

  1. Progression free survival (PFS)

    Baseline to measured date of progression or death from any cause

    Time frame: evaluated in 24 months since the treatment began

Secondary outcomes

  1. Objective response rate (ORR)

    Baseline to measured stable disease

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

  2. Disease control rate (DCR)

    Baseline to measured progressive disease

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

  3. 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

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

  4. Overall survival (OS)

    Baseline to measured date of death from any cause

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

  5. 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

    Time frame: up to 24 months

07

Study locations

1 of 1 sites recruiting
  • Jun Wang
    Shijiazhuang, Hebei, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06323265
Lead sponsor
Hebei Medical University Fourth Hospital
Responsible party
Jun wang (Study Principal Investigator, Hebei Medical University Fourth Hospital) — Principal investigator
First posted
Mar 21, 2024
Start date
Mar 26, 2024
Primary completion
Apr 1, 2025 (estimated)
Completion
Apr 1, 2026 (estimated)
Last update
Mar 27, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion