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