A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)

NCT07099898 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 2236742025-521627-78-00
• Study Type: interventional
• Target: 420
• Locations: 24 countries
• Sites: 114

Brief Summary

In this study researchers are testing Risvutatug rezetecan also known as (Ris-Rez) a new medicine that targets specific proteins (B7-H3) on cancer cells, thereby reducing the cancer's ability to grow and spread. This study specifically aims to evaluate how well Ris-Rez works in treating relapsed SCLC compared to standard treatment topotecan, by checking whether Ris-Rez makes cancers smaller or disappear completely and if it helps participants live longer. The study is also assessing whether Ris-Rez is safe and tolerated well by participants compared to topotecan and provide a better understanding of the main side effects of both drugs. Participants with relapsed SCLC will be randomly divided into two groups: one group receiving Ris-Rez and the other receiving topotecan.

Conditions

Neoplasms, Lung

Keywords

Small Cell Lung Cancer (SCLC); Risvutatug Rezetecan; Topotecan; EMBOLD SCLC-301; Ris-Rez

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS is defined as the time from the date of randomization to the date of death by any cause

  Up to approximately 113 weeks

Secondary Outcomes (19)

• Objective Response Rate (ORR)

  Up to approximately 139 weeks

• Duration of Response (DoR)

  Up to approximately 139 weeks

• Progression-free survival (PFS)

  Up to approximately 139 weeks

• Disease control rate (DCR) 12

  Up to approximately 11 weeks

• Brain PFS

  Up to approximately 139 weeks

Study Arms (2)

Ris-Rez

EXPERIMENTAL

Biological: Ris-Rez

Topotecan

ACTIVE COMPARATOR

Drug: Topotecan

Interventions

Topotecan DRUG

Topotecan will be administered

Topotecan

Ris-Rez BIOLOGICAL

Ris-Rez will be administered

Ris-Rez

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Adults \>18 or the minimum legal adult age at the time the informed consent form is signed
• Has histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
• Has received 1 prior platinum-based systemic therapy with a PD- (L)1 inhibitor for at least 2 cycles of therapy and a chemotherapy free-interval of \>30 days, with documented progression. Participants with prior tarlatamab treatment in either the first- or second-line ES-SCLC setting are eligible.
• Has at least 1 target lesion per RECIST 1.1, as determined by the investigator.
• Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol.
• Has adequate organ function and an ECOG performance status of 0 or 1

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Pathological diagnosis of complex SCLC or transformed SCLC.
• Limited stage small cell lung cancer at diagnosis
• Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload or treatments targeting B7-H3.
• Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
• Has severe, uncontrolled or active cardiovascular disorders.
• Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.
• Known active infectious diseases requiring systemic treatment or known Human immunodeficiency virus (HIV).
• Has symptomatic brain metastases or untreated progression exclusively due to brain metastasis during or after the last treatment prior to screening, evidence of leptomeningeal/meningeal/brainstem metastasis or evidence of spinal cord metastases.
• Has any evidence of current interstitial lung disease or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high dose steroids.
• Has significant pulmonary disease or respiratory impairment (e.g., uncontrolled asthma/COPD, restrictive lung disease),
• Has active Hepatitis B or Hepatitis C

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (114)

GSK Investigational Site

Mar del Plata, Buenos Aires, 7600, Argentina

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GSK Investigational Site

Buenos Aires, C1426ABP, Argentina

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GSK Investigational Site

Ciudad Autonoma de Buenos Aire, C1012AAR, Argentina

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GSK Investigational Site

Ciudad Autonoma de Buenos Aire, C1426AGE, Argentina

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GSK Investigational Site

Rosario, S2000 DEJ, Argentina

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GSK Investigational Site

Vicente López, 1602, Argentina

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GSK Investigational Site

Blacktown, New South Wales, 2148, Australia

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GSK Investigational Site

St Leonards, New South Wales, 2065, Australia

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GSK Investigational Site

Nedlands, Western Australia, 6009, Australia

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GSK Investigational Site

Barretos, 14784-400, Brazil

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GSK Investigational Site

CuritibaPR, 80810-050, Brazil

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GSK Investigational Site

Florianópolis, 88020-210, Brazil

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GSK Investigational Site

Porto Alegre, 90020-090, Brazil

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GSK Investigational Site

Porto Alegre, 90610-000, Brazil

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GSK Investigational Site

Rio de Janeiro, 22250-905, Brazil

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GSK Investigational Site

São Paulo, 04312903, Brazil

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GSK Investigational Site

Pleven, 5800, Bulgaria

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GSK Investigational Site

Plovdiv, Bulgaria

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GSK Investigational Site

Rousse, 7002, Bulgaria

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GSK Investigational Site

Ottawa, Ontario, K1H 8L6, Canada

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GSK Investigational Site

Toronto, Ontario, M5G 1Z5, Canada

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GSK Investigational Site

Montreal, Quebec, H3T 1E2, Canada

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GSK Investigational Site

Montreal, Quebec, H4J 1C5, Canada

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GSK Investigational Site

Vaasa, 65130, Finland

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GSK Investigational Site

Boulogne-Billancourt, 92100, France

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GSK Investigational Site

Grenoble, 38043, France

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GSK Investigational Site

Saint-Herblain, 44805, France

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GSK Investigational Site

Karlsruhe, Baden-Wurttemberg, 76137, Germany

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GSK Investigational Site

Augsburg, 86156, Germany

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GSK Investigational Site

Esslingen am Neckar, 73730, Germany

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GSK Investigational Site

Lübeck, 23562, Germany

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GSK Investigational Site

München, 81377, Germany

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GSK Investigational Site

Nuremberg, 90340, Germany

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GSK Investigational Site

Stuttgart, 70376, Germany

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GSK Investigational Site

Athens, 115 22, Greece

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GSK Investigational Site

Athens, 11526, Greece

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GSK Investigational Site

Athens, 12462, Greece

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GSK Investigational Site

Heraklion Crete, 71110, Greece

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GSK Investigational Site

Pylaia Thessaloniki, 570 01, Greece

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GSK Investigational Site

Pylaia Thessaloniki, 57001, Greece

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GSK Investigational Site

Gyöngyös, 3200, Hungary

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GSK Investigational Site

Kecskemét, 6000, Hungary

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GSK Investigational Site

Törökbálint, 2045, Hungary

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GSK Investigational Site

Dublin, D09 V2N0, Ireland

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GSK Investigational Site

Jerusalem, 9112001, Israel

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GSK Investigational Site

Tel Aviv, 6423906, Israel

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GSK Investigational Site

Bergamo, Italy

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GSK Investigational Site

Orbassano, 10043, Italy

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GSK Investigational Site

Pisa, 57124, Italy

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GSK Investigational Site

Fukuoka, 812-8582, Japan

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GSK Investigational Site

Hokkaido, 060-8648, Japan

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GSK Investigational Site

Ishikawa, 920-8530, Japan

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GSK Investigational Site

Kagoshima, 890-8520, Japan

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GSK Investigational Site

Kanagawa, 241-8515, Japan

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GSK Investigational Site

Kanagawa, 252-0375, Japan

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GSK Investigational Site

Kochi, 783-8505, Japan

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GSK Investigational Site

Kyoto, 612-8555, Japan

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GSK Investigational Site

Mie, 515-8544, Japan

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GSK Investigational Site

Miyagi, 980-8574, Japan

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GSK Investigational Site

Osaka, 541-8567, Japan

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GSK Investigational Site

Osaka, 573-1191, Japan

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GSK Investigational Site

Osaka, 594-0073, Japan

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GSK Investigational Site

Tokyo, 113-8603, Japan

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GSK Investigational Site

Tokyo, 113-8677, Japan

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GSK Investigational Site

Toyama, 930-8550, Japan

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GSK Investigational Site

Guadalajara, 44280, Mexico

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GSK Investigational Site

Mexico City, 06700, Mexico

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GSK Investigational Site

Mexico City, 06760, Mexico

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GSK Investigational Site

Monterrey, 66260, Mexico

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GSK Investigational Site

Kielce, 25-640, Poland

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GSK Investigational Site

Otwock, 05-400, Poland

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GSK Investigational Site

Poznan, 60-569, Poland

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GSK Investigational Site

Siedlce, 08-110, Poland

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GSK Investigational Site

Almada, 2805-267, Portugal

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GSK Investigational Site

Guimarães, 4835-044, Portugal

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GSK Investigational Site

Craiova Dolj, Dolj, 200535, Romania

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GSK Investigational Site

Cluj-Napoca, 400015, Romania

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GSK Investigational Site

Craiova, 200542, Romania

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GSK Investigational Site

Floreşti, 407280, Romania

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GSK Investigational Site

Iași, 700451, Romania

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GSK Investigational Site

Timișoara, 300329, Romania

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GSK Investigational Site

Changwon, 51472, South Korea

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GSK Investigational Site

Cheongju Chungcheongbuk-do, 28644, South Korea

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GSK Investigational Site

Daegu, 41404, South Korea

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GSK Investigational Site

Gyeonggi-do, 10408, South Korea

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GSK Investigational Site

Seongnam-si Gyeonggi-do, 13620, South Korea

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GSK Investigational Site

Seoul, 03722, South Korea

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GSK Investigational Site

Suwon Gyeonggi-do, 442723, South Korea

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GSK Investigational Site

Ulsan, 44033, South Korea

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GSK Investigational Site

Barcelona, 08035, Spain

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GSK Investigational Site

Barcelona, 8017, Spain

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GSK Investigational Site

Barcelona, 8036, Spain

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GSK Investigational Site

L'Hospitalet de Llobrega, 08908, Spain

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GSK Investigational Site

Las Palmas de Gran Canar, 35016, Spain

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GSK Investigational Site

Madrid, 28007, Spain

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GSK Investigational Site

Madrid, 28034, Spain

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GSK Investigational Site

Madrid, 28041, Spain

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GSK Investigational Site

Madrid, 28046, Spain

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GSK Investigational Site

Santander, 39011, Spain

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GSK Investigational Site

Stockholm, 171 64, Sweden

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GSK Investigational Site

Basel, 4031, Switzerland

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GSK Investigational Site

Lausanne, 1011, Switzerland

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GSK Investigational Site

Adana, Adana, 01140, Turkey (Türkiye)

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GSK Investigational Site

Samsun, Atakum, 55200, Turkey (Türkiye)

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GSK Investigational Site

Ankara, 06010, Turkey (Türkiye)

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GSK Investigational Site

Ankara, 06100, Turkey (Türkiye)

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GSK Investigational Site

Ankara, 06520, Turkey (Türkiye)

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GSK Investigational Site

Diyarbakır, 21280, Turkey (Türkiye)

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GSK Investigational Site

Istanbul, 34010, Turkey (Türkiye)

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GSK Investigational Site

Izmir, 35110, Turkey (Türkiye)

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GSK Investigational Site

Izmir, 35340, Turkey (Türkiye)

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GSK Investigational Site

London, W1G 6AD, United Kingdom

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GSK Investigational Site

Portsmouth, PO6 3LY, United Kingdom

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GSK Investigational Site

Truro, TR1 3LJ, United Kingdom

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MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 1, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): November 5, 2027
• Study Completion (Estimated): September 28, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

PT (2); BU (3); IT (3); RO (6); PL (4); DE (7); ES (10); FR (3); IE (1); CH (2); TU (9); IL (2); BR (7); CA (4); JP (16); GB (3); AR (6); KR (8); AU (3); SE (1); GR (6); FI (1); ME (4); HU (3)