Real-World Study on the Efficacy of IBI-322 in Combinatio... | NCT05991180

Studies
Real-World Study on the Efficacy of IBI-322 in Combination With Lenvatinib for the Treatment of Extensive Stage Small Cell Lung Cancer

NCT05991180

Sponsor

Hunan Province Tumor Hospital

Status

Unknown status

Last Update Posted

Dec 27, 2023Actual

Enrollment

160Estimated

Phase

Not provided

Conditions

Extensive-stage Small-cell Lung Cancer

Interventions

Not provided

Countries

China

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

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 25, 2023Actual

Primary Completion Date

Dec 1, 2024Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Aug 6, 2023

First Submission Date that Met QC Criteria

Aug 6, 2023

First Posted Date

Aug 14, 2023Actual

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

Dec 25, 2023

Last Update Posted Date

Dec 27, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yongchang Zhang, Professor, Deputy Director of Thoracic Oncology Department, Hunan Province Tumor HospitalPrincipal Investigator

Lead Sponsor

Hunan Province Tumor HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.

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

Retention

Enrollment

160Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ORR	Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects	2 years

Secondary Outcomes

Measure	Description	Time Frame
PFS	Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)	2 years
OS	Defined as the time from the start of treatment to the death of the subject due to any cause.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must be ≥18 years.
Provision of fully informed consent prior to any study specific procedures.
Patients with extensive stage SCLC diagnosed by pathology (as staged by the American Veterans Lung Cancer Association (VALG)), who do not have an imaging response during first-line treatment with PD-(L)1 inhibitors, or who progress after imaging reactions on first-line therapy (the most recent regimen prior to enrollment must contain PD-(L)1 inhibitors).
According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Not provided

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

Extensive Stage Small Cell Lung Cancer

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yongchang Zhang, MD	Contact	+8613873123436		zhangyongchang@csu.edu.cn
Nong Yang, MD	Contact	+8613873123436		yangnong0217@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hunan Cancer hospital	Recruiting	Changsha	Hunan		China

Condition Browse Module

MeSH Terms

ID	Term
D055752	Small Cell Lung Carcinoma

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided