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

Recruiting · NCT07099898 · Interventional (participants receive a specific treatment) · Lead sponsor: GlaxoSmithKline

View the official record on ClinicalTrials.gov →

Interventions studied

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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

Exclusion criteria

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

Where it is running

60 locations listed across 2 US states.

GSK Investigational Site - Los Angeles, California, United States
GSK Investigational Site - Wilson, North Carolina, United States
GSK Investigational Site - Almada, Portugal
GSK Investigational Site - Ankara, Turkey (Türkiye)
GSK Investigational Site - Ankara, Turkey (Türkiye)
GSK Investigational Site - Ankara, Turkey (Türkiye)
GSK Investigational Site - Athens, Greece
GSK Investigational Site - Athens, Greece
GSK Investigational Site - Athens, Greece
GSK Investigational Site - Augsburg, Germany
GSK Investigational Site - Barcelona, Spain
GSK Investigational Site - Barcelona, Spain
GSK Investigational Site - Barcelona, Spain
GSK Investigational Site - Barretos, Brazil
GSK Investigational Site - Basel, Switzerland
GSK Investigational Site - Bergamo, Italy
GSK Investigational Site - Boulogne-Billancourt, France
GSK Investigational Site - Budapest, Hungary
GSK Investigational Site - Buenos Aires, Argentina
GSK Investigational Site - Changwon, South Korea
GSK Investigational Site - Chemnitz, Germany
GSK Investigational Site - Cheongju Chungcheongbuk-do, South Korea
GSK Investigational Site - Ciudad Autonoma de Buenos Aire, Argentina
GSK Investigational Site - Ciudad Autonoma de Buenos Aire, Argentina
GSK Investigational Site - Cluj-Napoca, Romania
GSK Investigational Site - Craiova, Romania
GSK Investigational Site - CuritibaPR, Brazil
GSK Investigational Site - Daegu, South Korea
GSK Investigational Site - Diyarbakır, Turkey (Türkiye)
GSK Investigational Site - Dublin, Ireland
GSK Investigational Site - Esslingen am Neckar, Germany
GSK Investigational Site - Farkasgyepű, Hungary
GSK Investigational Site - Floreşti, Romania
GSK Investigational Site - Florianópolis, Brazil
GSK Investigational Site - Fukuoka, Japan
GSK Investigational Site - Genova, Italy
GSK Investigational Site - Gliwice, Poland
GSK Investigational Site - Grenoble, France
GSK Investigational Site - Guadajalara, Mexico
GSK Investigational Site - Guimarães, Portugal
GSK Investigational Site - Gyeonggi-do, South Korea
GSK Investigational Site - Gyöngyös, Hungary
GSK Investigational Site - Heidelberg, Germany
GSK Investigational Site - Heraklion, Greece
GSK Investigational Site - Hokkaido, Japan
GSK Investigational Site - Iași, Romania
GSK Investigational Site - Ishikawa, Japan
GSK Investigational Site - Istanbul, Turkey (Türkiye)
GSK Investigational Site - Izmir, Turkey (Türkiye)
GSK Investigational Site - Izmir, Turkey (Türkiye)
GSK Investigational Site - Jerusalem, Israel
GSK Investigational Site - Kagoshima, Japan
GSK Investigational Site - Kanagawa, Japan
GSK Investigational Site - Kanagawa, Japan
GSK Investigational Site - Kecskemét, Hungary
GSK Investigational Site - Kielce, Poland
GSK Investigational Site - Kochi, Japan
GSK Investigational Site - Kyoto, Japan
GSK Investigational Site - L'Hospitalet de Llobrega, Spain
GSK Investigational Site - Las Palmas de Gran Canar, Spain

Showing 60 of 132 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →