Phase I Clinical Study of Tislelizumab in Combination With Bevacizumab and Pemetrexed for the First-line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer in Elderly Patients

Tianjin Medical University Cancer Institute and Hospital1 site in 1 country30 target enrollmentAugust 1, 2022

ConditionsNon-Small Cell Lung Cancer

InterventionsTislelizumab Pemetrexed Bevacizumab

Overview

Phase: Phase 1
Intervention: Tislelizumab
Conditions: Non-Small Cell Lung Cancer
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Enrollment: 30
Locations: 1
Primary Endpoint: Objective response rate
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This single-center, open-label, phaseⅠstudy is to evaluate the efficacy of Tislelizumab in combination with Bevacizumab and Pemetrexed for the first-line treatment of advanced Non-squamous Non-small Cell lung cancer in Elderly Patients

Detailed Description

Patients received Bevacizumab, 7.5mg/kg d1, Pemetrexed, 500mg/m2, d1 and Tislelizumab 200mg, d4, Q3W, for 4 cycles; then Tislelizumab 200mg, d1 Q3w and Bevacizumab 7.5mg/kg d1 Q3W, maintenance treatment for 2 years.

Registry

clinicaltrials.gov

Start Date

August 1, 2022

End Date

February 1, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who must meet all the following criteria should be selected:
•Agree to participate in this trial and sign written informed consent form.
•Male or female, age ≥ 65 years.
•Expected survival time ≥ 3 months and able to be followed-up.
•Stage IIIB/IIIC/IV non-squamous NSCLC patients without previous systemic therapy (according to AJCC8th) or patients with stage IIIB/IIIC/IV non-squamous NSCLC who have relapsed after surgery (if adjuvant therapy was administered, more than 6 months of drug discontinuation is required).
•Without EGFR mutation and ALK and ROS1 fusion genes.
•Patients can not receive concurrent chemoradiothrapy after multidisciplinary consultation and discussion.
•At least one measurable tumor indicator along with a lesion with a maximum diameter of ≥ 1 cm (diagnosed by imaging, e.g., CT, MRI, ECT).
•ECOG PS 0-1 within 7 days before enrollment.
•Within 14 days prior to the start of treatment, laboratory results of routine blood, liver and kidney function and hormone levels meet the following criteria: platelets (PLT) ≥ 100 × 109/L, neutrophils (ANC) ≥ 1.5 × 109/L, hemoglobin (HGB) ≥ 90 g/L, aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) (≤ 5 × ULN for liver metastases), alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for liver metastases), total bilirubin (TIBC) ≤ 1.5 × ULN, and alanine aminotransferase (ALT) ≤ 1.5 × ULN. × ULN), alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for liver metastases), total bilirubin (TIBC) ≤ 1.5 × ULN, serum creatinine (CR) ≤ 1.25 × ULN; cortisol and thyroid function are in the normal range.

Exclusion Criteria

•Subjects who meet any of the following criteria could not participate in this study:
•Received bevacizumab and/or pemetrexed within 6 months prior to the first dose of study drug.
•Other malignant tumors with disease progression or requiring aggressive treatment within 5 years of enrollment. Exceptions included early-stage tumors (carcinoma in situ or stage I tumors) that received radical treatment, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast that received potentially radical treatment.
•Have had an allogeneic tissue/organ transplant.
•Participating or have participated in investigational drug therapy within 4 weeks prior to the first dose of the trial.
•Receiving systemic hormone therapy or are receiving any other form of immunosuppressive therapy (except docetaxel pretreated glucocorticoids) within 14 days prior to the first dose of the experimental treatment.
•Received anti-tumor monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or major surgical procedure within 1 month prior to the first use of study drug; received chest radiation therapy greater than 30 Gy within 6 months prior to the first use of study drug; received chest radiation therapy at 30 Gy or less within 1 month prior to the first use of study drug.
•Prior treatment with other PD-1 antibodies and other immunotherapy targeting PD-1/PD-L
•Active autoimmune disease requiring systemic therapy (e.g., use of disease-relieving drugs, corticosteroids, or immunosuppressants) within the past 2 years Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic therapy.
•Having congenital or acquired immune deficiency (e.g., HIV-infected patients), active hepatitis B (HBV-DNA ≥ 2.5 x 10\^3 copies/ml), or hepatitis C (positive for hepatitis C antibodies and HCV-RNA above the lower limit of detection for the assay).

Arms & Interventions

Tislelizumab+Bevacizumab+Pemetrexed

Bevacizumab，7.5mg/kg，d1; Pemetrexed，500mg/m2，d1; Tislelizumab，200mg，d4; Q3W for 4 cycles; Maintenance treatment ： Tislelizumab，200mg，d1; Bevacizumab，7.5mg/kg，d1; Q3W for 2 years

Intervention: Tislelizumab

Tislelizumab+Bevacizumab+Pemetrexed

Bevacizumab，7.5mg/kg，d1; Pemetrexed，500mg/m2，d1; Tislelizumab，200mg，d4; Q3W for 4 cycles; Maintenance treatment ： Tislelizumab，200mg，d1; Bevacizumab，7.5mg/kg，d1; Q3W for 2 years

Intervention: Pemetrexed

Tislelizumab+Bevacizumab+Pemetrexed

Bevacizumab，7.5mg/kg，d1; Pemetrexed，500mg/m2，d1; Tislelizumab，200mg，d4; Q3W for 4 cycles; Maintenance treatment ： Tislelizumab，200mg，d1; Bevacizumab，7.5mg/kg，d1; Q3W for 2 years

Intervention: Bevacizumab