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

NCT07099898

RecruitingPhase 3

Sponsor: GlaxoSmithKline

Conditions: Neoplasms, Lung

Interventions: Ris-Rez, Topotecan

Countries: Argentina, Australia, Brazil, Bulgaria, Canada, Finland, France, Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (126)
  • Mar del Plata, Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Ciudad Autonoma de Buenos Aire, Argentina
  • Ciudad Autonoma de Buenos Aire, Argentina
  • Rosario, Argentina
  • Vicente López, Argentina
  • Blacktown, New South Wales, Australia
  • St Leonards, New South Wales, Australia
  • Nedlands, Western Australia, Australia
  • Barretos, Brazil
  • CuritibaPR, Brazil
  • Florianópolis, Brazil
  • Porto Alegre, Brazil
  • Porto Alegre, Brazil
  • Rio de Janeiro, Brazil
  • São Paulo, Brazil
  • Pleven, Bulgaria
  • Plovdiv, Bulgaria
  • Rousse, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Ottawa, Ontario, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Montreal, Quebec, Canada
  • Vaasa, Finland
  • Boulogne-Billancourt, France
  • Grenoble, France
  • Saint-Herblain, France
  • Karlsruhe, Baden-Wurttemberg, Germany
  • + 96 more on CT.gov