Tislelizumab +Bevacizumab+pc for Untreated EGFR+ and High PD-L1 Non-squamous NSCLC (NCT05394233) | Clinical Trial Compass
UnknownPhase 2
Tislelizumab +Bevacizumab+pc for Untreated EGFR+ and High PD-L1 Non-squamous NSCLC
China20 participantsStarted 2022-06-01
Plain-language summary
A study to evaluate the efficacy and safety of tislelizumab combined with bevacizumab and platinum-based pemetrexed in the treatment of naïve patients with advanced non-squamous non-small cell lung cancer with sensitive EGFR mutations and high PD-L1 expression Prospective, open-label, single-arm phase II clinical study
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. ≥ 18 and ≤ 75 years of age. Signed the informed consent form prior to patient entry
✓. Histologically or pathologically confirmed non-squamous non-small cell lung cancer(NSCLC) with stage IV /III
✓. Patients with EGFR sensitive mutations: 19del and L858R who have not been treated with TKI for the first time, the patients need to provide the test results of the certified detection platform, and the PD-L1 expression based on tissue specimen detection is greater than 50% (PD-L1 detection clone number: SP263).
✓. A World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) Performance Status Score (PS) of 0 or 1 at the time of recruitment.
✓. Adequate organ and bone marrow function, defined as:
✓. The expected survival time of patients is ≥3 months
✓. Weight \> 30 kg
✓. Have the ability to sign the informed consent form and comply with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.
Exclusion criteria
✕. Patients with grade ≥2 non-infectious pneumonia.
✕. History of allogeneic organ transplantation, except corneal transplantation.
✕. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], diverticulitis \[except diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatous vasculitis, Graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]). Exceptions to this standard include:
What they're measuring
1
middle progression free survival
Timeframe: Estimated about 6 months
Trial details
NCT IDNCT05394233
SponsorSichuan Cancer Hospital and Research Institute
✕. Uncontrolled concurrent diseases, including but not limited to: persistent or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active ILD , Severe chronic gastrointestinal disease with diarrhea, or a psychiatric/social condition that may limit compliance with study requirements, cause a significantly increased risk of AEs, or interfere with the subject's ability to provide written informed consent.
✕. History of another primary malignant tumor, except for the following cases;
✕. History of active primary immunodeficiency
✕. Active infection, including tuberculosis (clinical assessment, including clinical history, physical examination, radiographic findings, and tuberculosis testing consistent with local clinical practice).
✕. Known history of human immunodeficiency virus (HIV) infection; known active syphilis infection.