Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer

A Phase III, Multisite, Double-blinded Randomized Trial of BNT327 in Combination With Chemotherapy (Etoposide/Carboplatin) Compared to Atezolizumab in Combination With Chemotherapy (Etoposide/Carboplatin) in Participants With First-line Extensive-stage Small-cell Lung Cancer

This is a Phase III, multisite, randomized, double-blinded study to investigate pumitamig (BNT327) combined with chemotherapy (etoposide/carboplatin) compared to atezolizumab combined with chemotherapy (etoposide/carboplatin) for the treatment of participants with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).

Study Overview

• Status: Recruiting
• Conditions: Extensive-stage Small-cell Lung Cancer
• Intervention / Treatment: Drug: Pumitamig; Drug: Atezolizumab; Drug: Etoposide; Drug: Carboplatin (or cisplatin if carboplatin is not tolerated)

Detailed Description

There are two stages in this study: Stage 1 will have two treatment arms and one control arm, and Stage 2 will have a treatment arm and a control arm. The control arms in Stages 1 and 2 are the same.

Each stage of the study consists of a screening period (up to 21 days), an induction period followed by a maintenance period (until confirmed disease progression, intolerable toxicity, participant withdrawal, study termination or up to 2 years [whichever occurs first]), and a follow-up (FU) period for all participants (2 safety FU visits and survival FU visits).

In Stage 1, eligible participants will be randomized (1:1:1) to the arms. In Stage 2, participants will then be randomized (1:1) to the arms. The randomization will be stratified based on the following factors:

1. Brain or liver metastases per investigator assessment (presence versus absence);
2. Smoking status (smoker versus never-smoker); and
3. Geography.

Participants will be allowed to switch to cisplatin if carboplatin is not tolerated at the investigator's discretion.

• Study Type: Interventional
• Enrollment (Estimated): 621
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: BioNTech clinical trials patient information; Phone Number: +49 6131 9084; Email: patients@biontech.de

Study Locations

• Australia
  • Cairns, Australia, 4870
    • Recruiting
    • Cairns Hospital
  • Saint Leonards, Australia, 2065
    • Recruiting
    • Royal North Shore Hospital
  • New South Wales
    • Waratah, New South Wales, Australia, 2298
      • Recruiting
      • Calvary Mater Newcastle
    • Wollongong, New South Wales, Australia, 2500
      • Recruiting
      • Cancer Care Wollongong Pty Limited
  • Queensland
    • Cairns, Queensland, Australia, 4870
      • Recruiting
      • Cairns Hospital
  • South Australia
    • Kurralta Park, South Australia, Australia, 5037
      • Recruiting
      • Icon Cancer Centre Kurralta Park
    • Woodville, South Australia, Australia, 5011
      • Recruiting
      • The Queen Elizabeth Hospital
  • Victoria
    • Frankston, Victoria, Australia, 3199
      • Recruiting
      • Peninsula & South Eastern Haematology and Oncology Group
    • Heidelberg, Victoria, Australia, 3084
      • Recruiting
      • Olivia Newton-John Cancer Wellness & Research centre
    • St Albans, Victoria, Australia, 3021
      • Recruiting
      • Western Health Sunshine Hospital
• China
  • Baoding, China, 071105
    • Recruiting
    • Affiliated Hospital of Hebei University
  • Beijing, China, 100730
    • Recruiting
    • Peking Union Medical College Hospital
  • Beijing, China, 100050
    • Recruiting
    • Beijing Friendship Hospital, Capital Medical University
  • Beijing, China, 101149
    • Recruiting
    • Beijing Chest Hospital,Capital Medical University
  • Bengbu, China, 233004
    • Recruiting
    • The First Affiliated Hospital Of Bengbu Medical College
  • Hangzhou, China, 310022
    • Recruiting
    • Zhejiang Medical University, Zhejiang Cancer Hospital
  • Jiamusi, China, 154007
    • Recruiting
    • Jiamusi Cancer Hospital
  • Jinan, China, 250013
    • Recruiting
    • Shandong University - Jinan Central Hospital
  • Jinan, China, 250117
    • Recruiting
    • Shandong Cancer Hospital and Institute
  • Linyi, China, 276034
    • Recruiting
    • Linyi Cancer Hospital
  • Nanchang, China, 330006
    • Recruiting
    • The First Affiliated Hospital of Nanchang University
  • Nanjing, China, 210029
    • Recruiting
    • Jiangsu Peoples Hospital
  • Nanning, China, 530000
    • Recruiting
    • Guangxi Tumour Hospital
  • Shanghai, China, 200030
    • Recruiting
    • Shanghai Chest Hospital
  • Shanghai, China, 200032
    • Recruiting
    • Fudan University - Shanghai Cancer Center (FUSCC)
  • Shantou, China, 515041
    • Recruiting
    • Cancer Hospital of Shantou University Medical College
  • Suzhou, China, 215006
    • Recruiting
    • The First Affiliated Hospital of Soochow University
  • Taiyuan, China, 030013
    • Recruiting
    • Shanxi Provincial Tumor Hospital (Shanxi Oncology Hospital)
  • Wanzhou, China, 404000
    • Recruiting
    • Chongqing University Three Gorges Hospital
  • Wenzhou, China, 325000
    • Recruiting
    • The First Affiliated Hospital of Wenzhou Medical University
  • Wuhan, China, 430071
    • Recruiting
    • Zhongnan Hospital of Wuhan University
  • Xiangyang, China, 441000
    • Recruiting
    • Xiangyang Central Hospital
  • Xinxiang, China, 453100
    • Recruiting
    • The First Affiliated Hospital of Henan Medical University
  • Yangzhou, China, 225001
    • Recruiting
    • Northern Jiangsu Peoples Hospital (NJPH)
  • Zhejiang, China, 317000
    • Recruiting
    • Taizhou Hospital of Zhejiang Province
  • Jilin
    • Changchun, Jilin, China, 130012
      • Recruiting
      • Jilin Cancer Hospital
• Germany
  • Berlin, Germany, 13125
    • Recruiting
    • Evangelische Lungenklinik Berlin
  • Bonn, Germany, 53123
    • Recruiting
    • Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling
  • Gera, Germany, 07548
    • Recruiting
    • SRH Wald-Kliniken Gera GmbH
  • Großhansdorf, Germany, 22927
    • Recruiting
    • LungenClinic Grosshansdorf GmBH
  • Neuss, Germany, 41462
    • Recruiting
    • MVZ for oncology and hematology Rhein-Kreis Neuss GmbH
  • Wuppertal, Germany, 42283
    • Recruiting
    • Helios Klinikum Wuppertal-Universitaet Witten-Herdecke
• Japan
  • Bunkyō City, Japan, 113-8677
    • Recruiting
    • Tokyo Metropolitan Komagome Hospital
  • Chūōku, Japan, 104-0045
    • Recruiting
    • National Cancer Center Hospital
  • Fukuoka, Japan, 811-1395
    • Recruiting
    • National Hospital Organization Kyushu Cancer Center
  • Himeji, Japan, 670-8520
    • Recruiting
    • National Hospital Organization Himeji Medical Center
  • Iwakuni, Japan, 740-8510
    • Recruiting
    • National Hospital Organization Iwakuni Clinical Center
  • Kurume, Japan, 830-0011
    • Recruiting
    • Kurume University Hospital
  • Matsuyama, Japan, 791-0280
    • Recruiting
    • National Hospital Organization Shikoku Cancer Center
  • Miyagi, Japan, 981-0914
    • Recruiting
    • Sendai Kousei Hospital
  • Niigata, Japan, 951-8566
    • Recruiting
    • Niigata Cancer Center Hospital
  • Okayama, Japan, 700-8558
    • Recruiting
    • Okayama University Hospital
  • Osaka, Japan, 541-8567
    • Recruiting
    • Osaka Prefectural Hospital Organization Osaka International Cancer Institute
  • Sakai, Japan, 591-8555
    • Recruiting
    • NHO Kinki Chuo Chest Medical Center
• Poland
  • Konin, Poland, 62-500
    • Recruiting
    • KOMED Roman Karaszewski I Wspolnicy Spolka Jawna
  • Krakow, Poland, 31-501
    • Recruiting
    • Futuremeds Krakow
  • Przemyśl, Poland, 37-700
    • Recruiting
    • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
• South Korea
  • Seoul, South Korea, 6351
    • Recruiting
    • Samsung Medical Center
  • Seoul, South Korea, 3722
    • Recruiting
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 5505
    • Recruiting
    • Asan Medical Center (AMC)
  • Guro-gu
    • Seoul, Guro-gu, South Korea, 8308
      • Recruiting
      • Korea University Guro Hospital
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, South Korea, 10408
      • Recruiting
      • National Cancer Center
    • Suwon, Gyeonggi-do, South Korea, 16499
      • Recruiting
      • Ajou University Hospital
    • Suwon, Gyeonggi-do, South Korea, 16247
      • Recruiting
      • The Catholic University of Korea, St. Vincent's Hospital
  • Gyeongsangnam-do
    • Jinju, Gyeongsangnam-do, South Korea, 52727
      • Recruiting
      • Gyeongsang National University Hospital (GNUH)
  • Namdong-gu
    • Incheon, Namdong-gu, South Korea, 21565
      • Recruiting
      • Gachon University Gil Medical Center
• Spain
  • Madrid, Spain, 28007
    • Recruiting
    • Hospital General Universitario Gregorio Maranon (HGUGM)
  • Seville, Spain, 41014
    • Recruiting
    • Hospital Universitario Nuestra Senora de Valme
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hospital Clinico Universitario Lozano Blesa de Zaragoza
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 1130
    • Recruiting
    • Acibadem Adana Hospital
  • Adana, Turkey (Türkiye), 1140
    • Recruiting
    • Seyhan Medical Park Hospital
  • Adana, Turkey (Türkiye), 1250
    • Recruiting
    • Baskent University Adana Turgut Noyan Application and Research Center
  • Ankara, Turkey (Türkiye), 6800
    • Recruiting
    • Ankara Bilkent City Hospital
  • Ankara, Turkey (Türkiye), 6010
    • Recruiting
    • Gulhane Training and Research Hospital
  • Ankara, Turkey (Türkiye), 06170
    • Recruiting
    • Ankara Etlik City Hospital
  • Ankara, Turkey (Türkiye), 6680
    • Recruiting
    • Liv Hospital Ankara
  • Ankara, Turkey (Türkiye), 6200
    • Recruiting
    • Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
  • Ankara, Turkey (Türkiye), 6230
    • Recruiting
    • Hacettepe University Medical Faculty Hospital
  • Ankara, Turkey (Türkiye), 6520
    • Recruiting
    • Memorial Ankara Hospital
  • Ankara, Turkey (Türkiye), 6560
    • Recruiting
    • Gazi University, Medical Faculty Hospital
  • Antalya, Turkey (Türkiye)
    • Recruiting
    • Akdeniz University Hospital
  • Edirne, Turkey (Türkiye), 22030
    • Recruiting
    • Trakya University Faculty of Medicine
  • Istanbul, Turkey (Türkiye), 34718
    • Recruiting
    • Yeditepe University Kosuyolu Hospital
  • Istanbul, Turkey (Türkiye), 34010
    • Recruiting
    • Koc Universitesi Hastanesi (Koc University Hospital)
  • Istanbul, Turkey (Türkiye), 34295
    • Recruiting
    • Medical Park Florya Hospital
  • Istanbul, Turkey (Türkiye), 41380
    • Recruiting
    • Goztepe Prof. Dr. Suleyman Yalcin City Hospital
  • Izmir, Turkey (Türkiye), 35575
    • Recruiting
    • Medical Point Izmir Hospital
  • Kocaeli, Turkey (Türkiye), 41380
    • Recruiting
    • Kocaeli University Medical Faculty Hospital
  • Mamak, Turkey (Türkiye), 06220
    • Recruiting
    • Ankara University Medical Faculty Hospital
  • Sakarya, Turkey (Türkiye), 54290
    • Recruiting
    • Sakarya University Training and Research Hospital
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
  • Cottingham, United Kingdom, HU16 5JQ
    • Recruiting
    • Hull University Teaching Hospitals NHS Trust
  • Exeter, United Kingdom, EX2 5DW
    • Recruiting
    • Royal Devon and Exeter Hospital, Royal Devon University Healthcare NHS Foundation Trust
  • Leeds, United Kingdom, LS9 7TF
    • Recruiting
    • St James'S University Hospital - Leeds Teaching Hospitals Nhs Trust
  • London, United Kingdom, SE1 9RT
    • Recruiting
    • Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
  • Preston, United Kingdom, PR2 9HT
    • Recruiting
    • Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
  • Lancashire
    • Manchester, Lancashire, United Kingdom, M20 4BX
      • Recruiting
      • The Christie NHS Foundation Trust
  • London
    • Chelsea, London, United Kingdom, SW3 6JJ
      • Recruiting
      • Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
    • Sutton, London, United Kingdom, SM2 5PT
      • Recruiting
      • Royal Marsden Hospital (Sutton) - Royal Marsden Nhs Foundation Trust
  • North Yorkshire
    • Huddersfield, North Yorkshire, United Kingdom, HD3 3EA
      • Recruiting
      • Huddersfield Royal Infirmary - Calderdale and Huddersfield NHS Foundation Trust
  • Northumberland
    • Newcastle upon Tyne, Northumberland, United Kingdom, NE7 7DN
      • Recruiting
      • Northern Centre for Cancer Care - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Recruiting
      • Nottingham University Hospitals NHS Trust - Nottingham City Hospital
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 7LE
      • Recruiting
      • Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
  • Scotland
    • Dundee, Scotland, United Kingdom, DD1 9SY
      • Recruiting
      • Ninewells Hospital and Medical School - Tayside Health Board
  • South Devon
    • Torquay, South Devon, United Kingdom, TQ2 7AA
      • Recruiting
      • Torbay and South Devon NHS Foundation Trust
  • Staffordshire
    • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
      • Recruiting
      • Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
  • Wales
    • Cardiff, Wales, United Kingdom, CF14 2TL
      • Recruiting
      • Velindre NHS Trust, Velindre Cancer Centre
  • West Midlands
    • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
      • Recruiting
      • New Cross Hospital
• United States
  • Florida
    • Clermont, Florida, United States, 34711
      • Terminated
      • Clermont Oncology Center
    • Palm Bay, Florida, United States, 32901
      • Recruiting
      • Cancer Care Centers of Brevard, Inc
  • Illinois
    • Niles, Illinois, United States, 60714
      • Recruiting
      • Illinois Cancer Specialists
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Recruiting
      • Fort Wayne Medical Oncology and Hematology, Inc
  • Iowa
    • Ames, Iowa, United States, 50010
      • Recruiting
      • McFarland Clinic
    • Cedar Rapids, Iowa, United States, 52403
      • Recruiting
      • Helen G. Nassif Community Cancer Center
  • Kentucky
    • Elizabethtown, Kentucky, United States, 42701
      • Recruiting
      • Baptist Health Hardin Cancer Center
  • Maryland
    • Frederick, Maryland, United States, 21704
      • Recruiting
      • Frederick Health Hospital- James M Stockman Cancer Institute
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Recruiting
      • Beth Israel Lahey Health - Lahey Hospital & Medical Center (LHMC), Lahey Clinic Medical Center
  • Mississippi
    • Southaven, Mississippi, United States, 38671
      • Recruiting
      • Baptist Cancer Center
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Recruiting
      • Nebraska Hematology-Oncology (NHO)
  • New York
    • White Plains, New York, United States, 10601
      • Recruiting
      • White Plains Hospital
  • Ohio
    • Akron, Ohio, United States, 44302
      • Recruiting
      • Cleveland Clinic - Akron General Hematology & Oncology
    • Canton, Ohio, United States, 44708
      • Recruiting
      • Cleveland Clinic Mercy Hospital Cancer Center
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • The Christ Hospital Cancer Center
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
    • Cleveland, Ohio, United States, 44195-0001
      • Recruiting
      • Cleveland Clinic Foundation
    • Cleveland, Ohio, United States, 44111
      • Recruiting
      • The Cleveland Clinic Cancer Center At Fairview Hospital, Moll Pavilion
    • Kettering, Ohio, United States, 45429
      • Recruiting
      • Kettering Medical Center
    • Mayfield Heights, Ohio, United States, 44124
      • Recruiting
      • Cleveland Clinic - Hillcrest Hospital
  • Pennsylvania
    • Fountain Hill, Pennsylvania, United States, 18015-1153
      • Recruiting
      • St. Luke's Physician Group - St. Luke's Cancer Care Associates
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Recruiting
      • University of Tennessee Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas MD Anderson Cancer Center
    • Houston, Texas, United States, 77090
      • Terminated
      • Millennium Research and Clinical Development, LLC
    • Sugar Land, Texas, United States, 77479
      • Recruiting
      • Texas Oncology Cancer Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Virginia Cancer Specialists
    • Fredericksburg, Virginia, United States, 22408
      • Recruiting
      • Hematology Oncology Associates of Fredericksburg, Inc.
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University School of Medicine
    • Winchester, Virginia, United States, 22601
      • Recruiting
      • Shenandoah Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have histologically or cytologically confirmed ES-SCLC (using the AJCC [American Joint Committee on Cancer] tumor node metastasis staging system combined with Veterans Administration Lung Study Group [VALG]'s two stage classification scheme). For AJCC tumor node metastasis staging system: AJCC 8th edition stage IV (T any, N any, M1a/b/c), or T3~4 for multiple lung nodules or tumor/nodule volume that cannot be encompassed in a tolerable radiotherapy plan.
• Have not had prior systemic therapy for ES-SCLC. However, participants with prior chemoradiotherapy for limited-stage-SCLC must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible.
• Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate hematologic and organ function as defined in the protocol.

Exclusion Criteria:

• Have histologically or cytologically confirmed SCLC with combined histologies.

• Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:

  • Within 2 weeks: small molecule agents with half-life of <7 days; radiation outside the thoracic cavity including whole brain radiation. Of note, other local radiation for brain lesions (not whole brain) is allowed; local radiation for bone lesions is allowed. Palliative bone radiation or brain stereotactic radiosurgery would not require a washout period, but participants should recover from radiotherapy-related toxicity.
  • Within 4 weeks: radiation involving the thoracic cavity; small molecule targeted agents with half-life of ≥7 days; monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies.
  • Have received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or programmed death (ligand)-1 (PD[L]-1)/VEGF bispecific antibody.
  • Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.

• Have the following central nervous system metastases:

  • Participants with untreated brain metastases that are symptomatic or large (e.g., greater than 2 cm).
  • Participants with treated central nervous system (CNS) metastases who are not neurologically stable or on steroids (at a dosage greater than 10 mg/Day of prednisone or an equivalent dose of other corticosteroid) within 7 days before initiating study treatment of this study.
  • Participants with known leptomeningeal metastases.
• Have uncontrolled hypertension or poorly controlled diabetes prior to study treatment.
• Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess for which an interval of 6 months must pass before study entry. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation.
• Have a significant risk of hemorrhage (per investigator clinical judgment) as defined in the protocol.
• Have superior vena cava syndrome or symptoms of spinal cord compression that requires urgent medical intervention.

NOTE: 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: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stage 1 Control Arm - Atezolizumab + Etoposide + Carboplatin	Drug: Atezolizumab; Intravenous infusion; Drug: Etoposide; Intravenous infusion and capsules; Drug: Carboplatin (or cisplatin if carboplatin is not tolerated); Intravenous infusion
Experimental: Stage 1 Treatment Arm 1 - Pumitamig Dose 1 + Etoposide + Carboplatin	Drug: Pumitamig; Intravenous infusion; Other Names: BNT327; PM8002; BMS-986545; Drug: Etoposide; Intravenous infusion and capsules; Drug: Carboplatin (or cisplatin if carboplatin is not tolerated); Intravenous infusion
Experimental: Stage 1 Treatment Arm 2 - Pumitamig Dose 2 + Etoposide + Carboplatin	Drug: Pumitamig; Intravenous infusion; Other Names: BNT327; PM8002; BMS-986545; Drug: Etoposide; Intravenous infusion and capsules; Drug: Carboplatin (or cisplatin if carboplatin is not tolerated); Intravenous infusion
Active Comparator: Stage 2 Control Arm - Atezolizumab + Etoposide + Carboplatin	Drug: Atezolizumab; Intravenous infusion; Drug: Etoposide; Intravenous infusion and capsules; Drug: Carboplatin (or cisplatin if carboplatin is not tolerated); Intravenous infusion
Experimental: Stage 2 Treatment Arm - Pumitamig Dose 3 + Etoposide + Carboplatin	Drug: Pumitamig; Intravenous infusion; Other Names: BNT327; PM8002; BMS-986545; Drug: Etoposide; Intravenous infusion and capsules; Drug: Carboplatin (or cisplatin if carboplatin is not tolerated); Intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	OS defined as the time from randomization to death from any cause.	Up to approximately 46 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS rate based on investigator's assessment		At 6, 12, and 18 months
OS rate		At 6, 12, 18, and 24 months
Occurrence of dose delay, infusion interruption and discontinuation of study treatment due to TEAEs (including related TEAEs)		From first to last dose of study treatment, i.e., up to 2 years
Progression-free survival (PFS)	PFS defined as the time from randomization to first objective tumor progression (progressive disease per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]), or death from any cause, whichever occurs first.	Up to approximately 46 months
Objective response rate (ORR)	ORR defined as the proportion of participants in whom a complete response (CR) or partial response (PR) (based on investigator's assessment per RECIST v1.1) is observed as best overall response with confirmation.	Up to approximately 46 months
Duration of response (DOR)	DOR defined as the time from onset of objective response (confirmed CR or PR based on investigator's assessment per RECIST v1.1) to first occurrence of objective tumor progression (progressive disease per RECIST v1.1) or death from any cause, whichever occurs first.	Up to approximately 46 months
Occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs by relationship	TEAEs graded according to (US) National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0	From the first dose of study treatment to the 90-Day Follow-up Visit
Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Core 30 questionnaire (QLQ-C30) Global Health status/Quality-of-Life score (Items 29 and 30)	Global health status/QoL scale ranges in score from 0 to 100 with a high scale score representing a higher response level (e.g., high score for global health status/QoL is high QoL: high score for symptom scale/item is high symptomatology or problems).	Up to approximately 46 months
Change from baseline in EORTC QLQ-C30 physical functioning	Physical functioning scale ranges in score from 0 to 100 with a high scale score representing a higher response level (e.g., high score for functional scale is high/healthy level of functioning).	Up to approximately 46 months
Change from baseline in coughing scale of the EORTC Quality-of-Life-Lung cancer 29 questionnaire (QLQ-LC29)	Multi-item coughing scale ranges in score from 0 to 100 with a high score representing a high level of symptomatology or problems.	Up to approximately 46 months
Change from baseline in shortness of breath scale of the EORTC QLQ-LC29	Multi-item shortness of breath scale ranges in score from 0 to 100 with a high score representing a high level of symptomatology or problems.	Up to approximately 46 months
Change from baseline in coughed up blood item of the EORTC QLQ-LC29	Single item coughing up blood ranges in score from 0 to 100 with a high score representing a high level of symptomatology or problems.	Up to approximately 46 months
Change from baseline in Functional Assessment of Cancer Therapy-General overall bother item (FACT-GP5).	The FACT-G - Item GP5 (Version 4) is a single-item summary measure of the overall impact of treatment toxicity, based upon its association with the number and degree of AEs in clinical studies, rated on a 5-point Likert scale ("not at all" to "very much") with a recall period of past 7 days. A high score represents high level of problems.	Up to approximately 46 months

Collaborators and Investigators

• Sponsor: BioNTech SE
• Collaborators: Bristol-Myers Squibb
• Investigators: Study Director: BioNTech Responsible Person, BioNTech SE

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Immunotherapy; Cisplatin; Lung cancer; Carboplatin; Etoposide; Untreated; SCLC; Bispecific antibody; Check point inhibitor; Programmed death-ligand 1 (PD-L1); First-line ES-SCLC; Immunotherapy in combination with chemotherapy; Combination with other investigational agents; Vascular endothelial growth factor (VEGF) A; BNT327; Pumitamig
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glucosides; Glycosides; Coordination Complexes; Etoposide; Carboplatin; atezolizumab
• Other Study ID Numbers: BNT327-03; 2024-515765-34-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No