Multicenter, Prospective, Real World Study of Camrelizuma... | NCT05547737

Studies
Multicenter, Prospective, Real World Study of Camrelizumab in Cross-line Treatment of Non-small Cell Lung Cancer

NCT05547737

Sponsor

Henan Cancer Hospital

Status

Unknown status

Last Update Posted

Sep 21, 2022Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

NSCLC

Interventions

Camrelizumab

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

May 2022

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

Sep 21, 2022Estimated

Primary Completion Date

Sep 21, 2025Estimated

Completion Date

Sep 21, 2025Estimated

First Submitted Date

Jun 28, 2022

First Submission Date that Met QC Criteria

Sep 19, 2022

First Posted Date

Sep 21, 2022Actual

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

Sep 19, 2022

Last Update Posted Date

Sep 21, 2022Actual

Name	Class
Jiangsu HengRui Medicine Co., Ltd.	INDUSTRY

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

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

500Estimated

Name	Type	Description	Arm Group Labels	Other Names
Camrelizumab	Drug	Cross - line treatment of Camrelizumab in non-small cell lung cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR) in second-line treatment of patients with non-small cell lung cancer based on Camrelizumab regimen	CR+PR	Up to 12 months

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of Progression Free survival (PFS) in patients with non-small cell lung cancer based on first-line/second-line treatment with Camrelizumab	Progression free survival (PFS) according to RECIST 1.1	Up to 36 months
Evaluation of second progression-free survival (PFS2) in patients with non-small cell lung cancer based on Camrelizumab regimen

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent and volunteered to join the study
Aged >=18 years
Patients with stage IIIb, IV, or relapsed non-small cell lung cancer diagnosed cytologically or histopathologically as EGFR/ALK-
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
At least one measurable lesion (according to RECIST 1.1)
No prior systemic therapy for advanced/metastatic NSCLC
contraception

Exclusion Criteria:

Those who are allergic to drug treatment；
Patients who were also treated with other immunodrugs or therapies；
Patients who are participating in other intervention studies；
Patients with other malignant tumors at the same time；
Pregnant or lactating women；
The investigator did not consider the patients eligible to participate in the study under any other circumstances.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with stage IIIb, IV, or relapsed non-small cell lung cancer diagnosed cytologically or histopathologically as EGFR/ALK-

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qi Ming Wang, Doctor's degree	Contact	13783590691		qimingwang1006@126.com
zhen He, Doctor's degree	Contact	13523530961		13523530961@126.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided