A Clinical Study to Evaluate the Efficacy and Safety of H... | NCT05354700

Studies
A Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy in Patients With Extensive Small Cell Lung Cancer

NCT05354700

Sponsor

Shanghai Henlius Biotech

Status

Unknown status

Last Update Posted

May 4, 2022Actual

Enrollment

20Estimated

Phase

Phase 2

Conditions

Small-cell Lung Cancer

Interventions

HLX07
HLX10
carboplatin and etoposide

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

Official Title

An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + Chemotherapy in Patients With Extensive Small Cell Lung Cancer (ES-SCLC)

Status Module

Record Verification Date

Apr 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

Mar 29, 2023Estimated

Primary Completion Date

Mar 29, 2024Estimated

Completion Date

May 29, 2024Estimated

First Submitted Date

Apr 26, 2022

First Submission Date that Met QC Criteria

Apr 26, 2022

First Posted Date

Apr 29, 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

May 3, 2022

Last Update Posted Date

May 4, 2022Actual

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 is conducted in patients with advanced metastatic small cell lung cancer (SCLC). This study includes a single arm: the patients will receive HLX07 combination therapy with HLX10 and chemotherapy (carboplatin+etoposide) as first-line treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HLX07+HLX10+Chemotherapy	Experimental	HLX07+HLX 10+Chemotherapy (Carboplatin-Etoposide)	Drug: HLX07 Drug: HLX10 Drug: carboplatin and etoposide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HLX07	Drug	HLX07 is a recombinant humanized anti-EGFR monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.	HLX07+HLX10+Chemotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ORR	Objective response rate by investigator assessment per RECIST 1.1	up to 2 years
PFS	Progression-free survival by investigator assessment per RECIST v1.1	Up to 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system)
No prior systemic therapy for ES-SCLC
Major organs are functioning well
Participant must keep contraception

Exclusion Criteria:

Histologically or cytologically confirmed mixed SCLC
Known history of severe allergy to any monoclonal antibody
Known hypersensitivity to carboplatin or etoposide
Pregnant or breastfeeding females
Patients with a known history of psychotropic drug abuse or drug addiction
Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xuhui Hu, MD	Contact	18618313742		Xuhui_Hu@henlius.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jilin Cancer Hospital		Changchun	Jilin	130000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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

Intervention Browse Module

MeSH Terms

ID	Term
C000722210	HLX07
D016190	Carboplatin
D005047	Etoposide

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D011034	Podophyllotoxin
D013764	Tetrahydronaphthalenes

Browse Leaves

Not provided

Browse Branches

Not provided