Last updated 15 days ago
A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)
300 patients around the world
Available in Argentina
GlaxoSmithKline
5Research sites
300Patients around the world
This study is for people with
Lung cancer
Small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 with at least 2 cycles of therapy and a chemotherapy free-interval of >30 days, with documented progression.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 an ECOG performance status of 0 or 1.
- Participants are excluded from the study if any of the following criteria apply.Pathological diagnosis of complex SCLC or transformed SCLC.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 documented Hepatitis B or Hepatitis C.
Sites
Instituto de Diagnóstico e Investigaciones Metabólicas - IDIM - sede centro - CABA
Recruiting
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Centro Oncológico Korben
Recruiting
CEMER Centro Médico de Enfermedades Respiratorias - Vicente Lopez
Fundación Respirar
Recruiting
SponsorGlaxoSmithKline
Study typeInterventional
Conditions
Small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07099898
