BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)
A Phase 3 Open-Label, Randomized Controlled Trial of BL-M14D1 and Atezolizumab vs. Standard-of-Care Therapy in Patients With First-Line Extensive-Stage Small Cell Lung Cancer
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Contact
Study Contact
- Name: Loren VanPelt
- Phone Number: 425-453-6841
- Email: loren.vanpelt@systimmune.com
Study Locations
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Australian Capital Territory
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Garran, Australian Capital Territory, Australia, 2605
- Not yet recruiting
- Canberra Hospital
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Principal Investigator:
- Geoffrey Peters
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Queensland
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Southport, Queensland, Australia, 4215
- Not yet recruiting
- Tasman Oncology
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Principal Investigator:
- Kenneth O'Byrne
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South Australia
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Bedford Park, South Australia, Australia, 5042
- Not yet recruiting
- Flinders Medical Centre
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Principal Investigator:
- Chris Karapetis
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Gabrovo, Bulgaria, 5300
- Not yet recruiting
- MHAT Dr. Tota Venkova
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Principal Investigator:
- Bonka Popova
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Pleven, Bulgaria, 5800
- Not yet recruiting
- MHAT Heart and Brain
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Principal Investigator:
- Natalia Chilingirova
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Plovdiv, Bulgaria, 1431
- Not yet recruiting
- Medical Centre FutureMeds
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Principal Investigator:
- Nikolay Shopov
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Plovdiv, Bulgaria, 4002
- Not yet recruiting
- MHAT Pulmed
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Principal Investigator:
- Yanislav Ilieva
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Sofia, Bulgaria, 1431
- Not yet recruiting
- UMHAT Sveti Ivan Rilski
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Principal Investigator:
- Bozhil Robrev
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Sofia, Bulgaria, 1632
- Not yet recruiting
- MHAT Serdikamed
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Principal Investigator:
- Krasimir Koynov
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Alberta
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Calgary, Alberta, Canada, T2N 5G2
- Not yet recruiting
- Arthur Child Cancer Centre
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Principal Investigator:
- Vishal Navani
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Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
- Not yet recruiting
- University of Sherbrooke
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Principal Investigator:
- Francois Panet
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Ostrava, Czechia, 703 00
- Not yet recruiting
- Nemocnice Agel Vítkovice
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Principal Investigator:
- Jaromír Roubec
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Ostrava-Poruba, Czechia, 708 52
- Not yet recruiting
- Fakultní nemocnice Ostrava (FN Ostrava)
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Principal Investigator:
- Radoslava Černeková
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České Budějovice, Czechia, 370 01
- Not yet recruiting
- Nemocnice České Budějovice, a.s.
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Principal Investigator:
- Taťána Karpianusová
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Créteil, France, 94010
- Not yet recruiting
- Organization Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de Recherche Clinique (CRC) (Clinical Research Center)
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Principal Investigator:
- Christos Chouaid
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Lyon, France, 69008
- Not yet recruiting
- CLB - Centre Léon Bérard
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Principal Investigator:
- Romane Gille
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Marseille, France, 13273
- Not yet recruiting
- IPC - lnstitut Paoli-Calmettes
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Principal Investigator:
- Philippe Rochigneux
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Paris, France, 75005
- Not yet recruiting
- Universite Pierre et Marie Curie (UPMC) - Center de Recherche des Cordeliers (CRC)
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Principal Investigator:
- Nicolas Girard
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Saint-Herblain, France, 44805
- Not yet recruiting
- ICO - L'Institut de Cancérologie de L'Ouest
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Principal Investigator:
- Ludovic Doucet
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Tbilisi, Georgia, 0114
- Not yet recruiting
- LTD New Hospitals
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Principal Investigator:
- David Giorgadze
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Tbilisi, Georgia, 0186
- Not yet recruiting
- Caucasus Medical Centre
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Principal Investigator:
- Ivane Kiladze
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Tbilisi, Georgia, 0114
- Not yet recruiting
- LTD High Technology Hospital Medcenter
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Principal Investigator:
- Tamta Makharadze
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Tbilisi, Georgia, 0114
- Not yet recruiting
- Pineo Medical Ecosystem LtD
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Principal Investigator:
- Marita Gugunava
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Tbilisi, Georgia, 0119
- Not yet recruiting
- LLC Todua Clinic
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Principal Investigator:
- Tamar Melkadze
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Tbilisi, Georgia, 0180
- Not yet recruiting
- The First Medical Clinic LLC
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Principal Investigator:
- Nino Khupenia
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Cologne, Germany, 51109
- Not yet recruiting
- Lungenklinik/Lungenkrebszentrum Köln-Merheim
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Principal Investigator:
- Birgit Saers
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Essen, Germany, 45136
- Not yet recruiting
- KEM | Evangelische Kliniken Essen Mitte gGmbH
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Principal Investigator:
- Julia Galuba
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Halle, Germany, 06120
- Not yet recruiting
- Krankenhaus Martha-Maria Halle-Dölau
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Principal Investigator:
- Habil. Miriam Möller
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Athens, Greece, 11526
- Not yet recruiting
- Henry Dunant Hospital Center
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Principal Investigator:
- Giannis Mountzios
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Thessaloniki, Greece, 55236
- Not yet recruiting
- St Luke's Hospital
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Principal Investigator:
- Elena Fountzila
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Thessaloniki, Greece, 54639
- Not yet recruiting
- Theageneio Anticancer Hospital
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Principal Investigator:
- Dora Tsiouda
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Thessaloniki, Greece, 57001
- Not yet recruiting
- European Interbalkan Medical Center
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Principal Investigator:
- Ippokratis Korantzis
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Budapest, Hungary, 1083
- Not yet recruiting
- Semmelweis University Department of Pulmonology
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Principal Investigator:
- Veronika Müller
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Gyöngyös, Hungary, 7151
- Not yet recruiting
- Mátrai Gyógyintézet
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Principal Investigator:
- István Albert
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Kecskemét, Hungary, 6000
- Not yet recruiting
- Bács-Kiskun Vármegyei Oktatókórház, Oncoradiology Center
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Principal Investigator:
- Judit Kocsis
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Törökbálint, Hungary, 2045
- Not yet recruiting
- Református Pulmonológiai Intézet
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Principal Investigator:
- Gabriella Gálffy
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Aviano, Italy, 33081
- Not yet recruiting
- Centro di Riferimento Oncologico
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Principal Investigator:
- Elisa Bertoli
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Palermo, Italy, 90127
- Not yet recruiting
- Policlinico Paolo Giaccone University Hospital
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Principal Investigator:
- Valerio Gristina
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Roma, Italy, 00168
- Not yet recruiting
- Fondazione Policlinico Universitario A. Gemelli IRCCS
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Principal Investigator:
- Emilio Bria
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Roma, Italy, 00144
- Not yet recruiting
- Regina Elena Institute for Cancer Research
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Principal Investigator:
- Federico Cappuzzo
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Siena, Italy, 53100
- Not yet recruiting
- AOUS Le Scotte, UOC Immunoterapia Oncologica
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Principal Investigator:
- Michele Maio
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Bialystok, Poland, 15-540
- Not yet recruiting
- Uniwersytecki Szpital Kliniczny w Bialymstoku, II Klinika Chorob Pluc, Raka Pluca i Chorob Wewnetrznych
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Principal Investigator:
- Robert Mroz
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Gdynia, Poland, 81-519
- Not yet recruiting
- Szpitale Pomorskie Spolka z ograniczona odpowiedzialnoscia, Oddzial Onkologii i Radioterapii - Dzial Onkologii Klinicznej
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Principal Investigator:
- Magdalena Wroblewska
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Katowice, Poland, 40-514
- Not yet recruiting
- Oddzial Onkologii Klinicznej
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Principal Investigator:
- Jacek Kabut
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Lodz, Poland, 93-338
- Not yet recruiting
- Instytut "Centrum Zdrowia Matki Polki", Klinika Onkologii
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Principal Investigator:
- Ewa Kalinka
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Prabuty, Poland, 82-550
- Not yet recruiting
- Szpital Specjalistyczny w Prabutach Spolka z ograniczona odpowiedzialnoscia, Oddzial pulmonologii
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Principal Investigator:
- Anna Lowczak
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Belgrade, Serbia, 11000
- Not yet recruiting
- University Clinical Centre of Serbia, Clinic for pulmonology
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Principal Investigator:
- Natalija Samardzic
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Belgrade, Serbia, 11000
- Not yet recruiting
- University Hospital Medical Center Bezanijska Kosa
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Principal Investigator:
- Zoran Andric
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Kragujevac, Serbia, 34000
- Not yet recruiting
- University Clinical Center Kragujevac
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Principal Investigator:
- Jasmina Nedovic
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Novi Sad, Serbia, 21208
- Not yet recruiting
- Institute for pulmonary diseases of Vojvodina
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Principal Investigator:
- Goran Stojanovic
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A Coruña, Spain, 15006
- Not yet recruiting
- Complejo Hospitalario Universitario A Coruna (CHUAC) - Hospital Teresa Herrera
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Principal Investigator:
- Maria Rosario Garcia-Campelo
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Barcelona, Spain, 08041
- Not yet recruiting
- Hospital de La Santa Creu i Sant Pau
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Principal Investigator:
- Margarita Majem Tarruella
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Las Palmas de Gran Canaria, Spain, 35016
- Not yet recruiting
- Hospital Universitario Insular de Gran Canaria
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Principal Investigator:
- Delvys Rodríguez-Abreu
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Madrid, Spain, 28040
- Not yet recruiting
- Hospital Clinico San Carlos
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Principal Investigator:
- Carlos Aguado de la Rosa
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Madrid, Spain, 28050
- Not yet recruiting
- Centro de Investigación Oncológica Clara Campal
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Principal Investigator:
- Gema Garcia Ledo
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Arkansas
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Springdale, Arkansas, United States, 72762
- Not yet recruiting
- Highlands Oncology Group
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Principal Investigator:
- Eric Schaefer
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California
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Glendale, California, United States, 91203
- Recruiting
- Los Alamitos Hematology/Oncology Medical Group
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Principal Investigator:
- Michael Nguyen
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Long Beach, California, United States, 90806
- Recruiting
- MemorialCare Todd Cancer Institute
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Principal Investigator:
- Nilesh Vora
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Los Angeles, California, United States, 90067
- Recruiting
- Valkyrie Clinical Trials
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Principal Investigator:
- David Berz
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Contact:
- Trenis Palmer
- Phone Number: 912-398-3205
- Email: trenis.palmer@vctcare.com
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Florida
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Miami, Florida, United States, 33176
- Not yet recruiting
- Total Health and Research Center
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Principal Investigator:
- Francisco Belette
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New Jersey
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East Brunswick, New Jersey, United States, 08816
- Recruiting
- Astera Cancer Care
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Principal Investigator:
- Neel Belani
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Virginia
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Fairfax, Virginia, United States, 22031
- Recruiting
- Virginia Cancer Specialists
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Principal Investigator:
- Alexander Spira
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Histologically or cytologically confirmed first-line (1L), extensive-stage (ES) small cell lung cancer (SCLC)
- Must be eligible to receive a platinum-based chemotherapy regimen in combination with an anti-PD-L1 inhibitor.
- At least one measurable lesion based on RECIST v1.1 per investigator assessment.
- An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.
- Adequate organ function
Exclusion Criteria:
- Received any kind of platinum or etoposide treatment for limited stage (LS) SCLC within 6 months prior to enrollment.
- Participants who have received prior topoisomerase inhibitor-based ADC therapy.
- Participants with history of severe heart disease
- Participants with active autoimmune diseases and inflammatory diseases,
- Participants with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years
- Other protocol-defined inclusion/exclusion criteria apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Arm A
BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days
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BL-M14D1 administered in combination with atezolizumab.
BL-M14D1 will be given intravenously at the protocol-specified dose and schedule.
Atezolizumab will be administered intravenously according to the approved dosing regimen.
Other Names:
|
|
Experimental: Arm B
BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days
|
BL-M14D1 administered in combination with atezolizumab.
BL-M14D1 will be given intravenously at the protocol-specified dose and schedule.
Atezolizumab will be administered intravenously according to the approved dosing regimen.
Other Names:
|
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Active Comparator: Arm C
Medications used in the Control Arm should be administered per local label or institutional guidelines. Induction therapy (4 cycles): Carboplatin (AUC of 5 mg/mL*min IV) on Day 1 of each 21-day cycle Etoposide (100 mg/m2 IV) on Days 1 through 3 of each 21-day cycle Atezolizumab (1200 mg) IV on Day 1 of each 21-day cycle Maintenance therapy (continues until discontinuation criteria are met): Atezolizumab (1200 mg) IV on Day 1 of each 21-day cycle Lurbinectedin (3.2 mg/m2) IV on Day 1 of each 21-day cycle (to be added only if approved in region and as per PI discretion) |
Carboplatin and etoposide will be administered intravenously in combination with atezolizumab for induction therapy, followed by maintenance treatment with atezolizumab with or without lurbinectedin per protocol.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)
Time Frame: Up to approximately 2 years
|
Progression-free survival (PFS) is defined as the time from randomization to the first documented disease progression, as assessed by blinded independent central review (BICR) according to RECIST v1.1, or death from any cause, whichever occurs first.
|
Up to approximately 2 years
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival (OS)
Time Frame: Up to approximately 2 years
|
Overall survival (OS) is defined as the time from randomization to death from any cause.
|
Up to approximately 2 years
|
|
Participants with Serious Adverse Events (SAEs)
Time Frame: Up to approximately 5 years
|
Measuring the number of participants with serious adverse events (SAEs)
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Up to approximately 5 years
|
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Participants with treatment-emergent adverse events (TEAEs)
Time Frame: Up to approximately 5 years
|
Measuring the number of participants with Treatment-emergent adverse events (TEAEs) leading to discontinuation
|
Up to approximately 5 years
|
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Evaluate the safety of BL-M14D1 in combination with atezolizumab
Time Frame: Up to approximately 5 years
|
Death
|
Up to approximately 5 years
|
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Participants with abnormal lab results
Time Frame: Up to approximately 5 years
|
Measure number of participants with abnormal laboratory results
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Up to approximately 5 years
|
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To compare and quantify the impact of BL-M14D1 in combination with atezolizumab on participants' quality of life and functional status
Time Frame: Up to 5 years
|
Participant Reported Outcome (PRO) using 2 European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)
|
Up to 5 years
|
|
Overall Response Rate (ORR)
Time Frame: Up to 5 years
|
To assess the clinical efficacy of BL-M14D1 as measured by ORR using RECIST criteria v 1.1 per BICR and investigator
|
Up to 5 years
|
|
Disease Control Rate (DCR)
Time Frame: Up to 5 years
|
To assess the clinical efficacy of BL-M14D1 as measured by DCR using RECIST criteria v 1.1 per BICR and investigator
|
Up to 5 years
|
|
Duration Of Response (DOR)
Time Frame: Up to 5 years
|
To assess the clinical efficacy of BL-M14D1 as measured by DOR using RECIST criteria v 1.1 per BICR and investigator or death from any cause, whichever occur first
|
Up to 5 years
|
|
Time To Response (TTR)
Time Frame: Up to 5 years
|
To assess the clinical efficacy of BL-M14D1 as measured by TTR using RECIST criteria v 1.1 per BICR and investigator
|
Up to 5 years
|
|
Progression Free Survival (PFS)
Time Frame: Up to 5 years
|
To assess the clinical efficacy of BL-M14D1 as measured by PFS using RECIST criteria v 1.1 by investigator or death from any cause, whichever occurs first
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Junliang Cai, MD, SystImmune Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Lung Diseases
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Carcinoma, Small Cell
- Organic Chemicals
- Hydrocarbons
- Hydrocarbons, Cyclic
- Carbohydrates
- Podophyllotoxin
- Tetrahydronaphthalenes
- Naphthalenes
- Polycyclic Aromatic Hydrocarbons
- Hydrocarbons, Aromatic
- Polycyclic Compounds
- Glucosides
- Glycosides
- Coordination Complexes
- Etoposide
- Carboplatin
- PM 01183
- atezolizumab
- EC regimen
Other Study ID Numbers
Other Study ID Numbers
- BL-M14D1-LC-301
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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