Tislelizumab +Bevacizumab+pc for Untreated EGFR+ and High PD-L1 Non-squamous NSCLC

NCT05394233 | Unknown Phase 2

• 1 other identifier: BAT1706-LJ2022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Non-squamous Non-small Cell Lung Cancer; EGFR Gene Mutation

Outcome Measures

Primary Outcomes (1)

• middle progression free survival

  To evaluate the median progression-free survival (middle) of tislelizumab combined with bevacizumab and platinum-based pemetrexed in treatment-naïve advanced non-small cell lung cancer patients with sensitive EGFR mutations and high PD-L1 expression. progression free survival (mPFS)

  Estimated about 6 months

Study Arms (1)

tislelizumab combined with bevacizumab and platinum plus pemetrexed

EXPERIMENTAL

Drug: Induction Phase: Bevacizumab: 7.5 mg/kg administered as an IV infusion on Day 1 of each 3-week cycle for 4 cycles Cisplatin 75 mg/m2 will be administered as an intravenous infusion over 2 hours every 3 weeks for 4 cycles. Pemetrexed, 500 mg/m2, intravenously, every 3 weeks for 4 cycles Maintenance phase: Tislelizumab, 200 mg IV every 3 weeks;until disease progression or intolerance Bevacizumab: 7.5 mg/kg administered as an intravenous infusion on Day 1 of each 3-week cycle;until disease progression or intolerance

Drug: Tislelizumab Combined With Bevacizumab and Platinum Plus Pemetrexed

Interventions

Tislelizumab Combined With Bevacizumab and Platinum Plus Pemetrexed DRUG

Bevacizumab: 7.5 mg/kg administered as an intravenous infusion on Day 1 of each 3-week cycle Cisplatin 75 mg/m2 will be administered as an intravenous infusion over 2 hours, every 3 weeks, Pemetrexed, 500 mg/m2, intravenously every 3 weeks, Tislelizumab, 200 mg IV every 3 weeks

tislelizumab combined with bevacizumab and platinum plus pemetrexed

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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:
• Hemoglobin≥9.0 g/dL
• Absolute neutrophil count ≥1.5 × 109/L
• Platelet count ≥100 × 109/L
• Serum bilirubin ≤ 1.5 × upper limit of normal range (ULN). This does not apply to patients diagnosed with Gilbert's syndrome (persistent or recurrent hyperbilirubinemia \[primarily unconjugated bilirubin\] without evidence of hemolysis or liver pathology), which may be allowed after consultation with a physician patients participating in the study.
• ALT and AST ≤2.5 × ULN
• Measured creatinine clearance (CL) \>40 mL/min or Cockcroft-Gault calculated CL \>40 mL/min (using actual body weight) Men: Creatinine clearance (mLmin⁄) = body weight (kg) x (140-age) 72 x serum creatinine (mg/dL) Female: creatinine clearance (mLmin⁄) = body weight (kg) x (140-age) 72 x serum creatinine (mg/dL) x 0.85
• 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.

You may not qualify if:

• 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:
• Vitiligo or alopecia patients
• Patients with hypothyroidism who are stable on hormone replacement therapy (eg, after Hashimoto's syndrome)
• Any chronic skin disease that does not require systemic treatment
• Patients without active disease within the past 5 years may be included in the study, but only after consultation with the study physician
• Patients with celiac disease that can be controlled with diet alone
• 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;
• Malignant tumors with low potential risk of recurrence and no known active disease ≥5 years prior to first dose treated with curative intent
• Adequately treated non-melanoma skin cancer with no evidence of disease or lentigo maligna
• Adequately treated cervical carcinoma in situ without evidence of disease
• 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).

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (3)

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

Location

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

Location

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Location

MeSH Terms

Interventions

Bevacizumab; Platinum; Pemetrexed

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic

Study Officials

• juan li

  Sichuan Cancer Hospital Chengdu, Sichuan China

  STUDY DIRECTOR

Central Study Contacts

juan li

CONTACT

+86 13880276636; dr.lijuan@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of standard treatment department of medical oncology

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 27, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)