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Active (not recruiting) Phase 2 NCT05676931

Study With Various Immunotherapy Treatments in Participants With Lung Cancer

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

Sponsor: Gilead Sciences

trial.available_in: БГ
Overview
The purpose of this study is to assess the objective response rate (ORR) of immunotherapy-based combination therapy and to assess the safety and tolerability of immunotherapy-based combination therapy.
Description
The study includes multiple substudy arms (Substudy A, B, C), which will evaluate immunotherapy-based combinations.
Who can participate
Inclusion Criteria: * Histologically or cytologically documented Stage IV metastatic, NSCLC * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1 * At least one measurable target lesion per RECIST v1.1. * Adequate organ function * Participants must be willing to provide adequate tumor tissue Exclusion Criteria: * Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of Investigational Product(s) (IPs) hazardous * Use of any live vaccines against infectious diseases within 28 days of first dose of IP(s). * Use of supra-physiologic doses of corticosteroids (\> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications ≤ 14 days before the initiation of study treatment (absorbable topical corticosteroids are not excluded). * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations 10
Australia (1)
The Border Cancer Hospital
Albury , New South Wales
France (1)
CHU Bordeaux Centre Francois Magendie Hôpital du Haut Lévèque
Bordeaux
Georgia (1)
LTD High Technology Hospital Medcenter
Batumi
Italy (1)
Istituto Romagnolo per lo Studio dei Tumori-Dino Amadori - IRST
Meldola
Poland (1)
Szpitale Pomorskie sp. z o.o
Gdynia
South Korea (1)
Samsung Changwon Hospital
Changwon-Si
Spain (1)
Hospital de la Santa Creu i Sant Pau
Barcelona
Taiwan (1)
E-DA Healthcare Group E-DA Hospital
Kaoshiung
United Kingdom (1)
Barts Health NHS Trust St Bartholomew's Hospital
London
United States (1)
University of Alabama at Birmingham (UAB)
Birmingham , Alabama
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
21.02.2023
Completion date
01.12.2027
Registry ID
NCT05676931
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.