History of Changes for Study: NCT05468489

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

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Study Record Versions

Version	Submitted Date	Changes
1	July 19, 2022	None (earliest Version on record)
2	October 10, 2022	Recruitment Status, Study Status and Contacts/Locations
3	October 12, 2022	Study Status
4	October 18, 2022	Contacts/Locations and Study Status
5	December 12, 2022	Contacts/Locations and Study Status
6	March 22, 2023	Study Status and Contacts/Locations
7	May 31, 2023	Contacts/Locations and Study Status
8	June 28, 2023	Arms and Interventions, Study Identification, Study Status, Outcome Measures and Study Description
9	August 29, 2023	Contacts/Locations and Study Status
10	November 29, 2023	Contacts/Locations, Study Status and Study Identification
11	December 25, 2023	Study Status and Eligibility
12	January 10, 2024	Contacts/Locations and Study Status
13	February 5, 2024	Contacts/Locations and Study Status
14	February 29, 2024	Contacts/Locations and Study Status
15	April 29, 2024	Study Status and Contacts/Locations

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	HLX10-005-SCLC301-E
Brief Title:	To Evaluate Efficacy and Safety of HLX10 + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC
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)
Secondary IDs:

Study Status


Record Verification:	March 2023
Overall Status:	Recruiting
Study Start:	November 18, 2022
Primary Completion:	June 1, 2024 [Anticipated]
Study Completion:	December 31, 2025 [Anticipated]

First Submitted:	July 11, 2022
First Submitted that Met QC Criteria:	July 19, 2022
First Posted:	July 21, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	March 22, 2023
Last Update Posted:	March 24, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Shanghai Henlius Biotech
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:

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)

Detailed Description:

Conditions


Conditions:	Extensive Stage Small Cell Lung Cancer
Keywords:	Extensive Stage Small Cell Lung Cancer Anti-PD-1 Monoclonal Antibody

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	200 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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:
1.	OS [ Time Frame: A period from randomization through death regardless of causality (approximately up to 24 months). ] Overall assessment
Secondary Outcome Measures:
1.	ORR [ Time Frame: approximately up to 14 months ] Objective response rate
2.	PFS [ Time Frame: approximately up to 24 months ] Progression-free survival
3.	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: approximately up to 24 months ] Adverse events are described and graded using the grading categories defined in CTCAE, Version 5.0
4.	Maximum Plasma Concentration (Cmax) [ Time Frame: approximately up to 24 months ] The maximum concentration (Cmax) of HLX10 will be measured
5.	Minimum Plasma Concentration (Cmin) [ Time Frame: approximately up to 24 months ] The minimum concentration (Cmin) of HLX10 will be measured
6.	Average Plasma Concentration (Cavg) [ Time Frame: approximately up to 24 months ] The average Plasma Concentration (Cavg) of HLX10 will be measured

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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.

Contacts/Locations


Central Contact Person:	Marshika Vickers Telephone: 021-33395800 Ext. 6043 Email: mvickers@henlix.com
Central Contact Backup:	Jing Li Telephone: 021-33395800 Ext. 6043 Email: Jing_Li@henlius.com
Locations:	United States, Arkansas
	Research site [Recruiting] Springdale, Arkansas, United States, 72762 Contact:Contact: Study Coordinator
	United States, California
	Research site [Recruiting] Fountain Valley, California, United States, 92708 Contact:Contact: Study Coordinator
	Research site [Recruiting] Pasadena, California, United States, 91101 Contact:Contact: Study Coordinator
	United States, Florida
	Research site [Recruiting] Orange City, Florida, United States, 32763 Contact:Contact: Study Coordinator
	Research site [Recruiting] Pompano Beach, Florida, United States, 33064 Contact:Contact: Study Coordinator
	Research site [Recruiting] Tamarac, Florida, United States, 33321 Contact:Contact: Study Coordinator
	United States, Louisiana
	Research site [Recruiting] Covington, Louisiana, United States, 70433 Contact:Contact: Study Coordinator
	United States, Montana
	Research site [Recruiting] Billings, Montana, United States, 59102 Contact:Contact: Study Coordinator
	United States, Nevada
	Research site [Recruiting] Reno, Nevada, United States, 89502 Contact:Contact: Study Coordinator
	United States, Ohio
	Research site [Recruiting] Massillon, Ohio, United States, 44646 Contact:Contact: Study Coordinator
	Research site [Recruiting] Toledo, Ohio, United States, 43623 Contact:Contact: Study Coordinator
	United States, Texas
	Research site [Recruiting] Harlingen, Texas, United States, 78550 Contact:Contact: Study Coordinator
	Research site [Recruiting] Houston, Texas, United States, 77015 Contact:Contact: Study Coordinator
	Research site [Recruiting] Kingwood, Texas, United States, 77339 Contact:Contact: Study Coordinator
	United States, Washington
	Research site [Recruiting] Tacoma, Washington, United States, 98405 Contact:Contact: Study Coordinator

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: