Status:
UNKNOWN
Tislelizumab +Bevacizumab+pc for Untreated EGFR+ and High PD-L1 Non-squamous NSCLC
Lead Sponsor:
Sichuan Cancer Hospital and Research Institute
Conditions:
Non-squamous Non-small Cell Lung Cancer
EGFR Gene Mutation
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ca...
Detailed Description
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 ca...
Eligibility Criteria
Inclusion
- ≥ 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.
Exclusion
- 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).
- Known history of human immunodeficiency virus (HIV) infection; known active syphilis infection.
- Untreated active hepatitis B
- Hepatitis B patients who meet the following criteria are eligible for inclusion:
- \- Hepatitis B virus (HBV) load was below the lower limit of detection in our hospital before the first dose, and received anti-HBV therapy throughout the study period to avoid viral reactivation.
- Subjects with active hepatitis C (HCV) infection, HCV antibody positive patients only meet the study inclusion criteria when the polymerase chain reaction of HCV RNA is negative.
- Active brain metastases or spinal cord compression. Prior to study entry, all patients underwent MRI (preferred) or CT examination, preferably brain examination with intravenous contrast.
- Known allergy or hypersensitivity reaction to any study drug or any study drug excipients
- Previous exposure to immune-mediated therapy, including but not limited to: anti-PD-1, anti-PD-L1 and anti-programmed death ligand 2 (anti-PD-L2) antibodies, except for therapeutic anti-tumor vaccines .
- Live attenuated vaccine should be vaccinated within 30 days before the first dose, and live vaccine should not be vaccinated within 30 days after the last dose.
- Major surgery (as defined by the investigator) within 42 days prior to the first dose.
- Within 14 days before administration, immunosuppressive drugs are being used or have been used in the past. Exceptions to this standard include:
- Intranasal, inhaled, topical steroids, or topical steroid injections (eg, intra-articular injections)
- Systemic corticosteroid therapy not exceeding 10 mg/day of prednisone or its physiologic equivalent
- Steroids administered as prophylactic for hypersensitivity reactions (eg, prophylactic administration of CT scan)
- Pregnant or lactating female patients and fertile male or female patients are unwilling to take effective contraceptive measures from screening to 6 months after the last dose.
- Other researchers think that it is not suitable for inclusion.
- Mixed cell lung cancer: non-small cell and small cell mixed lung cancer and mixed adenosquamous lung cancer dominated by squamous cell carcinoma.
- Non-squamous non-small cell lung cancer with hemoptysis (\>50 ml/day); clinically significant hemoptysis or bleeding symptoms occurred within 3 months before enrollment.
- Patients with brain metastases whose symptoms are not controlled after treatment.
- Imaging (CT/MRI) shows that the tumor lesion is less than 5 mm away from the large blood vessels, there is a central tumor that invades the local large blood vessels and is less than 2 cm away from the bronchial tree; or there is an obvious lung cavity or necrotic tumor.
- Arterial/venous thrombotic events that occurred within 12 months before enrollment
- Patients with any severe and/or uncontrolled disease (hypertension, liver cirrhosis, heart failure, etc.)
- Major surgical operation or severe traumatic injury, fracture or ulcer occurred within 4 weeks before enrollment
- Severe weight loss (greater than 10%)
- Abnormal coagulation function, with bleeding tendency or receiving thrombolytic or anticoagulation therapy
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05394233
Start Date
June 1 2022
End Date
June 1 2024
Last Update
May 27 2022
Active Locations (3)
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1
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610041
2
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610041
3
Sichuan Cancer Hospital
Chengdu, Sichuan, China