NCT07434518

Brief Summary

The goal of this observational study is to evaluate the safety and efficacy of adebrelimab in the perioperative and advanced-stage treatment of small cell lung cancer （SCLC） under real-world conditions. The main questions it aims to answer are:

  1. 1.The safety of adebrelimab treatment in patients with advanced SCLC under real-world conditions, with a specific focus on the incidence of grade ≥3 immune-related adverse events. Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.
  2. 2.Observe and evaluate the efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. This includes overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR). Additionally, the study seeks to further explore the impact of patient baseline characteristics, such as brain metastases or liver metastases, and biomarkers on prognosis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Jan 2026Jun 2028

Study Start

First participant enrolled

January 27, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

January 29, 2026

Last Update Submit

February 20, 2026

Conditions

Small Cell Lung Cancer (SCLC)

Keywords

SafetyefficacySCLC

Outcome Measures

Primary Outcomes (1)

  • Immune-related adverse events

    The incidence of grade ≥3 immune-related adverse events. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.

Secondary Outcomes (7)

  • Overall survival (OS)

    From enrollment to the end of treatment at 12 months.

  • Progression-free survival (PFS)

    From enrollment to the end of treatment at 12 months.]

  • Objective response rate (ORR)

    From enrollment to the end of treatment at 12 months.

  • Disease control rate (DCR)

    From enrollment to the end of treatment at 12 months.

  • The density of immune cells in peripheral blood before and after treatment

    From enrollment to the end of treatment at 90 days.

  • +2 more secondary outcomes

Interventions

Adebrelimab (PD-L1 inhibitor)BIOLOGICAL

Investigating the efficacy and long-term safety of adebrelimab in different subgroups of SCLC patients (e.g., elderly patients, patients with comorbidities) in a real-world setting.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult advanced SCLC patients who are eligible for receiving adebrelimab treatment.

You may qualify if:

  • Histologically or cytologically confirmed extensive-stage small cell lung cancer;
  • Age ≥ 18 years;
  • The investigator determines that the patient is eligible for or is already receiving adebrelimab treatment.

You may not qualify if:

  • Patients concurrently receiving other immune-modulating drugs or therapies;
  • Patients currently participating in other interventional studies;
  • Patients with concurrent other malignancies;
  • Patients with missing key study-related data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai General Hospital

Shanghai, 201620, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood mononuclear cells, tumor tissue, lymph node tissue

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAntineoplastic Agents, ImmunologicalAntineoplastic AgentsTherapeutic Uses

Central Study Contacts

Qingnan Zhao, PhD

CONTACT

+86 (021)37798597zhaoqingnan2010@126.com

Qian Xue, PhD

CONTACT

+86 (021)37798597

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr./Chief Physician, Thoracic Surgery

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 25, 2026

Study Start

January 27, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations

CN(1)