ClinicalTrials.gov

History of Changes for Study: NCT05468489
To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC
Latest version (submitted May 7, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B 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
16 May 7, 2024 Study Status and Contacts/Locations
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Study NCT05468489
Submitted Date:  December 25, 2023 (v11)

Open or close this module Study Identification
Unique Protocol ID: ASTRIDE (HLX10-005-SCLC301-E)
Brief Title: To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC
Official Title: A Randomized, Open-label Study of Serplulimab Plus Chemotherapy (Carboplatin-Etoposide) in Comparison With Atezolizumab Plus Chemotherapy in Previously Untreated US Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) (ASTRIDE)
Secondary IDs:
Open or close this module Study Status
Record Verification: December 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:
December 25, 2023
Last Update Posted: December 27, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Shanghai Henlius Biotech
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary:

This is a randomized, open-label study of Serplulimab 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 (Serplulimab): Serplulimab + chemotherapy (carboplatin-etoposide)
  • Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)
Detailed Description:
Open or close this module Conditions
Conditions: Extensive Stage Small Cell Lung Cancer
Keywords: Extensive Stage Small Cell Lung Cancer
Anti-PD-1 Monoclonal Antibody
Open or close this module 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]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Serplulimab + chemotherapy
Serplulimab + chemotherapy (carboplatin-etoposide)
Drug: Serplulimab + chemotherapy (carboplatin-etoposide)

Drug: Serplulimab 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

Open or close this module 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 Serplulimab will be measured
5. Minimum Plasma Concentration (Cmin)
[ Time Frame: approximately up to 24 months ]

The minimum concentration (Cmin) of Serplulimab will be measured
6. Average Plasma Concentration (Cavg)
[ Time Frame: approximately up to 24 months ]

The average Plasma Concentration (Cavg) of Serplulimab will be measured
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

Voluntary participation in clinical studies.

Male or female aged ≥ 18 years at the time of signing the ICF.

Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).

No prior systemic therapy for ES-SCLC.

At least one measurable lesion as assessed according to RECIST 1.1 within 4 weeks prior to randomization.

Major organs are functioning well.

Every effort should be made to provide tumor tissues for the determination of PD-L1 expression.

An ECOG PS score of 0 or 1.

An expected survival ≥ 12 weeks.

Subjects with prior denosumab use that can and agree to switch to bisphosphonate therapy for bone metastases starting prior to randomization and throughout treatment.

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.

Patients with myocardial infarction within half a year before the first dose of the study drug, poorly controlled arrhythmia.

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.

Open or close this module Contacts/Locations
Central Contact Person: Marshika Vickers
Telephone: 510-445-0305
Email: marshika_vickers@henlius.com
Locations: United States, Arizona
City of Hope - Phoenix
[Recruiting]
Goodyear, Arizona, United States, 85338
Contact:Contact: Nikki Morris 770-400-6155 nikki.morris@coh.org
Contact:Contact: Rigoberto Garcia 623-207-3381 rigoberto.garcia@coh.org
Contact:Principal Investigator: Sagun Shrestha
United States, Arkansas
Highlands Oncology Group
[Recruiting]
Springdale, Arkansas, United States, 72762
Contact:Contact: Holly Martin 479-368-0314 hmartin@hogonc.com
Contact:Contact: Dongdong Yu 479-249-8028 dyu@hogonc.com
Contact:Principal Investigator: Eric Schaefer
United States, California
OPN - Oncology Physician Network
[Recruiting]
Arcadia, California, United States, 91107
Contact:Contact: Kandice Smith 747-270-6515 kandices@opnhc.com
Contact:Principal Investigator: Anthony Lam
Compassionate Care Research Group
[Recruiting]
Fountain Valley, California, United States, 92708
Contact:Contact: Shama Hussain 714-794-6674 Ext. 220 shama@compcareresearch.com
Contact:Principal Investigator: Eric Lee
Long Beach Memorial Medical Center
[Recruiting]
Long Beach, California, United States, 90806
Contact:Contact: Laura Macias 562-706-2701 LMacias@memorialcare.org
Contact:Principal Investigator: Nilesh Vora
OPN - Oncology Physician Network
[Recruiting]
Los Alamitos, California, United States, 90720
Contact:Contact: Kandice Smith 747-270-6515 kandices@opnhc.com
Contact:Principal Investigator: Vu Phan
California Research Institute
[Recruiting]
Los Angeles, California, United States, 90027
Contact:Contact: Clare Gregorio 818-572-6696 cg@careinst.com
Contact:Contact: janet Serrano js@careinst.com
Contact:Principal Investigator: Ghassan Al-Jazayrly
Kaiser Permanente Research (Southern California)
[Recruiting]
Los Angeles, California, United States, 90034
Contact:Contact: Linda Bawua 626-261-2864 Linda.X1.Bawua@kp.org
Contact:Principal Investigator: Eric McGary
Providence Medical Group
[Recruiting]
Santa Rosa, California, United States, 90027
Contact:Contact: Tracy Foster 707-521-3836 tracy.foster@stjoe.org
Contact:Contact: Melissa Phillips 707-521-3833 melissa.phillips2@stjoe.org
Contact:Principal Investigator: Ian Anderson
United States, Colorado
Lutheran Medical Cancer Center
[Recruiting]
Golden, Colorado, United States, 80401
Contact:Contact: Arjana Halilovic 303-403-3672 Arjana.Halilovic@imail.org
Contact:Principal Investigator: Karng Log
United States, Connecticut
The Stamford Hospital
[Recruiting]
Stamford, Connecticut, United States, 06904
Contact:Contact: Ed Hatton 203-276-2695 EHatton@stamhealth.org
Contact:Principal Investigator: Salvatore Del Prete
United States, Florida
Advanced Cancer Treatment Centers
[Recruiting]
Brooksville, Florida, United States, 34613
Contact:Contact: Sohail Chishti 727-276-1864 schishti@ariinstitute.com
Contact:Principal Investigator: Daniel Kerr
United Medical Group
[Recruiting]
Miami, Florida, United States, 33135
Contact:Contact: Luis Nieto 782-570-3900 lnieto@umgresearch.com
Contact:Contact: Lourdes Martinez 305-456-3905 lnieto@umgresearch.com
Contact:Principal Investigator: Alvaro Ocampo
Florida Cancer Affiliates- (Ocala Oncology - Main)
[Recruiting]
Ocala, Florida, United States, 34473
Contact:Contact: Sanjit Nirmalanandhan 352-732-4032 Sanjit.Nirmalanandhan@usoncology.com
Contact:Contact: Megan Cerrato 352-732-4032 megan.cerrato@usoncology.com
Contact:Principal Investigator: Rama Balaraman
Mid Florida Hematology and Oncology Center
[Recruiting]
Orange City, Florida, United States, 32763
Contact:Contact: Ashley Velez 386-774-1623 avelez@aorcorp.com
Contact:Contact: Kiran Penta 386-538-3169 kiran@aorcorp.com
Contact:Principal Investigator: Santosh Nair
BRCR Global
[Recruiting]
Plantation, Florida, United States, 33322
Contact:Contact: Alexander Chacin 561-447-0614 alexander@brcrglobal.com
Contact:Principal Investigator: Harshad Amin
Napa Research
[Recruiting]
Pompano Beach, Florida, United States, 33064
Contact:Contact: Maria Marin 954-323-2422 maria@napa-trials.com
Contact:Contact: Christopher Diamoy 954-773-9890 cdiamoy@napa-trials.com
Contact:Principal Investigator: David Kahn
Advanced Research
[Recruiting]
Tamarac, Florida, United States, 33321
Contact:Contact: Jake Hernandez 954-302-3163 jhernandez@advancedresearchfl.com
Contact:Principal Investigator: Sumit Sawhney
United States, Illinois
CTCA- Chicago
[Recruiting]
Chicago, Illinois, United States, 60099
Contact:Contact: Karina Szymulanska-Ramamurthy 847-731-4154 karina.szymulanska@coh.org
Contact:Contact: So-Hee Choi 847-731-5824 so-hee.choi@ctca-hope.com
Contact:Principal Investigator: Ajaz Khan
Northwest Oncology and Hematology
[Recruiting]
Rolling Meadows, Illinois, United States, 60008
Contact:Contact: Christine Chukwuoacha 847-577-0620 christinec@northwestoncology.com
Contact:Principal Investigator: Bruce Back
United States, Kansas
Cancer Center of Kansas
[Recruiting]
Wichita, Kansas, United States, 67214
Contact:Contact: Jad Kassem 316-613-4313 Jad.Kassem@cancercenterofkansas.com
Contact:Principal Investigator: Shaker Dakhil
United States, Louisiana
Research site
[Recruiting]
Covington, Louisiana, United States, 70433
Contact:Contact: Study Coordinator
Pontchartrain Cancer Center
[Recruiting]
Hammond, Louisiana, United States, 70433
Contact:Contact: Study Coordinator
Contact:Principal Investigator: David Oubre
Tulane Medical Center
[Recruiting]
New Orleans, Louisiana, United States, 70112
Contact:Contact: Priya Bhandari 504-988-6053 pbhandari@tulane.edu
Contact:Principal Investigator: Mark Sides
United States, Maryland
American Oncology Partners of Maryland, PA
[Recruiting]
Bethesda, Maryland, United States, 20817
Contact:Contact: Taylor Stutzman 301-571-2016 Taylor.Stutzman@aoncology.com
Contact:Contact: Jenelle Larkin 301-571-0019 Jenelle.larkin@aoncology.com
Contact:Principal Investigator: Ralph Boccia
United States, Michigan
Ascension Providence Hospital CK Potluri Cancer Center
[Recruiting]
Southfield, Michigan, United States, 48075
Contact:Contact: Karen Fife 248-849-5332 Karen.fife@ascension.org
Contact:Principal Investigator: Adam Forman
United States, Minnesota
Health Partners Cancer Center at Regions Hospital
[Recruiting]
Saint Paul, Minnesota, United States, 55101
Contact:Contact: Lisa Wahowske 651-254-1517 Lisa.wahowske@parknicollet.com
Contact:Contact: Octav Pacurar 651-254-3604 Octav.Pacurar@parknicollet.com
Contact:Principal Investigator: Yan Ji
United States, Mississippi
Hattiesburg Clinic Hematology/Oncology
[Recruiting]
Hattiesburg, Mississippi, United States, 39401
Contact:Contact: Christopher Sentell 601-288-2495 ChristopherH.Sentell@forrestgeneral.com
Contact:Principal Investigator: John Hrom
United States, Missouri
MidAmerica Division Inc., c/o Research Medical Center
[Recruiting]
Kansas City, Missouri, United States, 64132
Contact:Contact: Shannon Cone 816-276-3890 shannon.cone@hcamidwest.com
Contact:Principal Investigator: Joseph Stilwill
Oncology Hematology Associates
[Recruiting]
Springfield, Missouri, United States, 65807
Contact:Contact: Adrianna Moore 417-882-4880 adrianna.moore@aoncology.com
Contact:Contact: Jessica Cottengim 417-882-4880 Jessica.cottengim@aoncology.com
Contact:Principal Investigator: Robert Ellis
United States, Montana
St. Vincent Frontier Cancer Center
[Recruiting]
Billings, Montana, United States, 59102
Contact:Contact: Amanda Klein 406-238-6685 Amanda.Klein@imail.org
Contact:Contact: Brandi St. George 406-238-6963 Brandi.St.George@imail.org
Contact:Principal Investigator: Patrick Cobb
United States, Nebraska
Cancer Partners of Nebraska
[Recruiting]
Lincoln, Nebraska, United States, 68510
Contact:Contact: Shelia Evans 402-420-7000 sheilae@cancerpartners.com
Contact:Contact: Candice Toombs 402.420.7000 Candicet@cancerpartners.com
Contact:Principal Investigator: Steven Dunder
United States, Nevada
Renown Health
[Recruiting]
Reno, Nevada, United States, 89502
Contact:Contact: Lisa Lionetti-Freutel 775-982-4100 Lisa.Lionetti-Freutel@renown.org
Contact:Principal Investigator: Katharine Thomas
United States, New Hampshire
Dartmouth Hitchcock Medical Center
[Recruiting]
Lebanon, New Hampshire, United States, 03756
Contact:Contact: Shelia Sitaram 603-653-9054 Sheila.V.Sitaram@hitchcock.org
Contact:Principal Investigator: Konstantin Dragnev
United States, New Jersey
Summit Medical Group
[Recruiting]
Florham Park, New Jersey, United States, 07932
Contact:Contact: Michelle Mackenzie 973-436-1755 mmackenzie@summithealth.com
Contact:Contact: Romilda Moreira 973-436-1748 rmoreira@oursummit.onmicrosoft.com
Contact:Principal Investigator: KarLeung Siu
United States, New Mexico
CHRISTUS St. Vincent
[Recruiting]
Santa Fe, New Mexico, United States, 87505
Contact:Contact: Tamara Flys Tamara.Flys@stvin.org
Contact:Contact: Chris Gallegos Christopher.Gallegos@stvin.org
Contact:Principal Investigator: Andrea Teague
United States, New York
Elmhurst (BRANY site)
[Recruiting]
Elmhurst, New York, United States, 11373
Contact:Contact: Latif Kanwal 347-210-4279 Latifk@nychhc.org
Contact:Contact: Maria Ferreira-Ortiz (917) 572-3074 GORBEAM@nychhc.org
Contact:Principal Investigator: Muhammad Perwaiz
United States, Ohio
Summa Health
[Recruiting]
Akron, Ohio, United States, 44304
Contact:Contact: Alyssa Diamant 330-375-7353 diamanta@summahealth.org
Contact:Principal Investigator: Bradley Clifford
Cleveland Clinic Mercy Hospital
[Recruiting]
Canton, Ohio, United States, 44708
Contact:Contact: Janet Muckley 330-489-1111 Ext. 3919 mucklej@ccf.org
Contact:Principal Investigator: Mitchell Haut
Aultman Cancer Center
[Recruiting]
Canton, Ohio, United States, 44710
Contact:Contact: Carla Larch 330-363-1250 Carla.Larch@Aultman.com
Contact:Principal Investigator: Raza Khan
Gabrail Cancer Center (GCC) Research- Canton Facility
[Recruiting]
Canton, Ohio, United States, 44718
Contact:Contact: Amanda Rich 330-492-3345 Ext. 207 arich@gabrailcancercenter.com
Contact:Principal Investigator: Nashat Gabrail
University Hospitals Cleveland Medical Center
[Recruiting]
Cleveland, Ohio, United States, 44106
Contact:Contact: Valisha Watkins 216-286-3368 Valisha.Watkins@UHhospitals.org
Contact:Principal Investigator: Afshin Dowlati
Tricounty Hematology and Oncology Associates
[Recruiting]
Massillon, Ohio, United States, 44646
Contact:Contact: Joan Kaufman 330-489-1274 KAUFMAJ3@ccf.org
Contact:Principal Investigator: Nagajothi Nagaprasad
The Toledo Clinic
[Recruiting]
Toledo, Ohio, United States, 43623
Contact:Contact: Jennifer Martinez 419-794-7720 jmartinez@toledoclinic.com
Contact:Principal Investigator: Rex Mowat
United States, Texas
CHRISTUS Institute for Innovation & Advanced Clinical Care
[Recruiting]
Corpus Christi, Texas, United States, 78404
Contact:Contact: Melissa Shadle 361-726-0503 melissa.shadle@christushealth.org
Contact:Principal Investigator: Swetha Panati
DHR Research
[Recruiting]
Edinburg, Texas, United States, 78539
Contact:Contact: Ed Lopez 956-362-2394 ed.lopez@dhr-rgv.com
Contact:Principal Investigator: Joseph Cruz
The Center for Cancer and Blood Disorders
[Recruiting]
Fort Worth, Texas, United States, 76104
Contact:Contact: Anna Rose Abangan 817-759-7023 aabangan@txcc.com
Contact:Contact: Daphne Lindsey (817) 759-7040 dlindsey@txcc.com
Contact:Principal Investigator: Ray Page
Valley Cancer Associates
[Recruiting]
Harlingen, Texas, United States, 78550
Contact:Contact: Elyssa Navarro 956-608-6719 elyssa.navarro@elligodirect.com
Contact:Contact: April Valdivieso 210-889-4168 april.valdivieso@elligodirect.com
Contact:Principal Investigator: Todd Shenkenberg
Millennium Research and Clinical Development
[Recruiting]
Houston, Texas, United States, 77090
Contact:Contact: Crystal Matakatla 832-330-5090 cmatakatla@mphcc.com
Contact:Contact: John Waldron 832-330-5090 JWaldron@wmrad.com
Contact:Principal Investigator: Murtaza Bhuriwala
Lumi Research
[Recruiting]
Kingwood, Texas, United States, 77339
Contact:Contact: Scott Ward 281-809-0676 scott@lumiresearch.com
Contact:Principal Investigator: Saleha Sajid
Joe Arrington Cancer Research and Treatment Center
[Recruiting]
Lubbock, Texas, United States, 79410
Contact:Contact: Sonia Salas 806-725-8068 ssalas@covhs.org
Contact:Principal Investigator: Kiran Yalamanchili
The University of Texas Health Science Center at Tyler/HOPE Cancer Center
[Recruiting]
Tyler, Texas, United States, 75701
Contact:Contact: Gabriela Salazar 903-595-7044 gabriela.salazar@uttyler.edu
Contact:Principal Investigator: Arielle Lee
United States, Utah
Utah Cancer Specialists
[Recruiting]
Bountiful, Utah, United States, 84010
Contact:Contact: Emra Kazic 385-347-5435 ekazic@utahcancer.com
Contact:Principal Investigator: S. DiSean Kendall
United States, Washington
American Oncology Network Vista Oncology Division
[Recruiting]
Olympia, Washington, United States, 98502
Contact:Contact: Yiqun Xue 360-413-8880 yiqun.xue@aoncology.com
Contact:Contact: Ivy Zong 360-413-8880 ivy.zong@aoncology.com
Contact:Principal Investigator: Joseph Ye
Medical Oncology Associates, PS (dba Summit Cancer Centers)
[Recruiting]
Spokane Valley, Washington, United States, 99216
Contact:Contact: Monika Chaudhry 509-462-2273 Monika.Chaudhry@aoncology.com
Contact:Contact: Ashley Andrews 509-462-2273 Ashley.Connors@aoncology.com
Contact:Principal Investigator: Arvind Chaudhry
Northwest Medical Specialties, PLLC
[Recruiting]
Tacoma, Washington, United States, 98405
Contact:Contact: CarrieAnn Brown 253-720-2415 cbrown@nwmsonline.com
Contact:Principal Investigator: Andrea Veatch
United States, Wisconsin
University of Wisconsin Carbone Cancer Center
[Recruiting]
Madison, Wisconsin, United States, 53792
Contact:Contact: Lauren Schwalenberg 608-262-8126 schwalenberg@wisc.edu
Contact:Principal Investigator: Toby Campbell
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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