To Evaluate Efficacy and Safety of HLX10 + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC

Sponsor

Shanghai Henlius Biotech (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05468489

Collaborator

(none)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a randomized, open-label study of HLX10 plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC.

Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows:

Arm A (HLX10): HLX10 + chemotherapy (carboplatin-etoposide)
Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)

Condition or Disease	Intervention/Treatment	Phase
Extensive Stage Small Cell Lung Cancer	Drug: HLX10 + chemotherapy (carboplatin-etoposide) Drug: Atezolizumab + chemotherapy (carboplatin-etoposide)	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Open-label Study of HLX10 Plus Chemotherapy (Carboplatin-Etoposide) in Comparison With Atezolizumab Plus Chemotherapy in Previously Untreated US Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HLX10 + chemotherapy HLX10 + chemotherapy (carboplatin-etoposide)	Drug: HLX10 + chemotherapy (carboplatin-etoposide) Drug: HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. Drug: carboplatin and etoposide chemotherapeutics
Active Comparator: Atezolizumab + chemotherapy Atezolizumab + chemotherapy (carboplatin-etoposide)	Drug: Atezolizumab + chemotherapy (carboplatin-etoposide) Drug: Atezolizumab is a monoclonal antibody targeting PD-L1，developed by Roche Pharma AG. Drug: carboplatin and etoposide chemotherapeutics

Arm

Intervention/Treatment

Experimental: HLX10 + chemotherapy

HLX10 + chemotherapy (carboplatin-etoposide)

Drug: HLX10 + chemotherapy (carboplatin-etoposide)

Drug: HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. Drug: carboplatin and etoposide chemotherapeutics

Active Comparator: Atezolizumab + chemotherapy

Atezolizumab + chemotherapy (carboplatin-etoposide)

Drug: Atezolizumab + chemotherapy (carboplatin-etoposide)

Drug: Atezolizumab is a monoclonal antibody targeting PD-L1，developed by Roche Pharma AG. Drug: carboplatin and etoposide chemotherapeutics

Outcome Measures

Primary Outcome Measures

OS [A period from randomization through death regardless of causality (approximately up to 24 months).]
Overall assessment

Secondary Outcome Measures

ORR [approximately up to 14 months]
Objective response rate
PFS [approximately up to 24 months]
Progression-free survival
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [approximately up to 24 months]
Adverse events are described and graded using the grading categories defined in CTCAE, Version 5.0
Maximum Plasma Concentration (Cmax) [approximately up to 24 months]
The maximum concentration (Cmax) of HLX10 will be measured
Minimum Plasma Concentration (Cmin) [approximately up to 24 months]
The minimum concentration (Cmin) of HLX10 will be measured
Average Plasma Concentration (Cavg) [approximately up to 24 months]
The average Plasma Concentration (Cavg) of HLX10 will be measured

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shanghai Henlius Biotech

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Henlius Biotech

ClinicalTrials.gov Identifier:

NCT05468489

Other Study ID Numbers:

HLX10-005-SCLC301-E

First Posted:

Jul 21, 2022

Last Update Posted:

Jul 21, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shanghai Henlius Biotech

Extensive Stage Small Cell Lung Cancer

Anti-PD-1 Monoclonal Antibody

Additional relevant MeSH terms:

Lung Neoplasms

Small Cell Lung Carcinoma

Study Results

No Results Posted as of Jul 21, 2022