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Active (not recruiting) Phase 2 NCT05186974

Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)

Phase 2 – studying effectiveness and dosage
Conditions: Non-small Cell Lung Cancer

Sponsor: Gilead Sciences

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Overview
The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy (SG), and its dosing in combination with pembrolizumab or pembrolizumab and a platinum agent (carboplatin or cisplatin), in participants with advanced or metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC).
Who can participate
Key Inclusion Criteria: * Individuals with pathologically documented evidence of Stage IV non-small cell lung Cancer (NSCLC) disease at the time of enrollment * Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST Version 1.1 criteria by investigator * No prior systemic treatment for metastatic NSCLC * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Adequate hematologic counts * Adequate hepatic function Key Exclusion Criteria: * Mixed SCLC and NSCLC histology * Active second malignancy * NSCLC that is eligible for definitive local therapy alone * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy * Has an active autoimmune disease that has required systemic treatment in past 2 years * Has had an allogenic tissue/solid organ transplant. * Has severe (≥ Grade 3) hypersensitivity to SG, pembrolizumab, carboplatin, or cisplatin, their metabolites, or formulation excipient * Has received radiation therapy to the lung * Individuals may not have received systemic anticancer treatment within the previous 6 months * Is currently participating in or has participated in a study of an investigational agent * Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses * Known active central nervous system (CNS) metastases * History of cardiac disease * Active chronic inflammatory bowel disease * Active serious infection requiring antibiotics * Active or chronic hepatitis B infection * Positive hepatitis C antibody * Positive serum pregnancy test or women who are lactating Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations 12
Australia (1)
Southern Highlands Cancer Centre
Bowral , New South Wales
Canada (1)
CIUSSS Saguenay Lac St-Jean
Québec
France (1)
APHP - Hôpital Ambroise Paré
Boulogne-Billancourt
Germany (1)
Evangelische Lungenklinik Berlin Krakenhausbetriebs GmBH
Berlin
Hong Kong (1)
Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong
Italy (1)
ASST Spedali Civili di Brescia
Brescia
Malaysia (1)
Sultan Ismail Hospital
Johor Bahru
South Korea (1)
Chungbuk National University Hospital
Cheongju-si
Spain (1)
Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera
A Coruña
Taiwan (1)
Changhua Christian Hospital
Changhua
United Kingdom (1)
University Hospitals Birmingham NHS Foundation Trust
Birmingham
United States (1)
Alaska Oncology and Hematology, LLC.
Anchorage , Alaska
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
30.05.2022
Completion date
01.09.2026
Registry ID
NCT05186974
Source
anzctr
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