A Multicenter, Real-world Study of Adebrelimab in the Tre... | NCT06267170

Studies
A Multicenter, Real-world Study of Adebrelimab in the Treatment of Extensive Stage Small Cell Lung Cancer

NCT06267170

Sponsor

Henan Cancer Hospital

Status

Unknown status

Last Update Posted

Feb 20, 2024Actual

Enrollment

288Estimated

Phase

Not provided

Conditions

SCLC,Extensive Stage

Interventions

Adebrelimab

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 25, 2024Estimated

Primary Completion Date

Feb 25, 2025Estimated

Completion Date

Feb 25, 2026Estimated

First Submitted Date

Jan 30, 2024

First Submission Date that Met QC Criteria

Feb 18, 2024

First Posted Date

Feb 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2024

Last Update Posted Date

Feb 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study collected data on patients with extensive stage small cell lung cancer treated with Adebrelimab to investigate its safety and efficacy

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

288Estimated

Name	Type	Description	Arm Group Labels	Other Names
Adebrelimab	Drug	Treatment with adbelizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety (Occurrence of ≥ Grade 3 AE)	The incidence of grade 3 or higher adverse events	End of each cycle (each cycle is 28 days)

Secondary Outcomes

Measure	Description	Time Frame
PFS	Progression free survival	End of every two cycles (each cycle is 28 days)
ORR	Objective response rate	End of every two cycles (each cycle is 28 days)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sign informed consent and join the study voluntarily;
Patients diagnosed with extensive small cell lung cancer;
Age ≥18 years old;
Have at least one measurable lesion (according to RECIST 1.1);
The investigators judged that adebrelimab treatment was acceptable;
Contraception: Patients should agree that it must be used during the study period and within 6 months after the study ends Effective contraception;

Exclusion Criteria:

Allergic to adebrelimab and its excipients;
Patients who have also received other immune drugs or therapies;
Patients who are participating in other interventional studies;
patients with other malignant tumors;
Pregnant or lactating women;
The investigator considers that the patient is not suitable to participate in any other conditions of the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with extensive stage small cell lung cancer treated with adebrelimab

Sampling Method

Non-Probability Sample