Status:
UNKNOWN
Predictive Biomarker for Efficacy and Safety of Combination of Chemotherapy and Tislelizumab in NSCLC
Lead Sponsor:
Hao Long
Conditions:
Tislelizumab
Safety
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To explore the related biomarkers for safety and efficacy of the combination of chemotherapy and tislelizumab in non-small cell lung cancer
Eligibility Criteria
Inclusion
- Able to provide written informed consent and able to understand and agree to comply with study requirements and evaluation forms;
- Must be at least 18 years of age (or the legal age of commitment in the study occurrence jurisdiction) on the date the informed consent is signed;
- At least 1 measurable lesion as defined by RECIST v1.1 criteria; Note: Target lesions must be selected to meet one of the following criteria: 1) no prior local therapy or 2) subsequent progression within the previously treated local treatment area as determined by RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Eligible for platinum-based doublet chemotherapy;
- pre-treatment tumor tissue samples for biomarker analysis can be provided;
- Adequate hematology and end-organ function as defined by the following laboratory values (≤ 7 days prior to first dose):
- Patients did not require blood transfusion, platelet transfusion, or growth factor support ≤ 14 days prior to blood draw: i. Absolute neutrophil count ≥ 1.5 \* 109/L ii. Platelets ≥ 100 \* 109/L iii. Hemoglobin ≥ 90 g/L
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN), or glomerular filtration rate ≥ 60 mL/min calculated by CKD-EPI formula;
- AST and ALT ≤ 2.5 times ULN, or AST and ALT ≤ 5 times ULN in patients with a documented history of liver metastases;
- Serum total bilirubin ≤ 1.5 times ULN (total bilirubin must be \< 3 times ULN for patients with Gilbert's syndrome)
- International normalized ratio (INR) ≤ 1.5 or prothrombin time ≤ 1.5 times ULN;
- Partial thromboplastin time (APTT) ≤ 1.5 × ULN;
- Females of childbearing potential must agree to practice highly effective contraception for the duration of the study and for ≥ 120 days after dosing and have a negative serum pregnancy test ≤ 7 days before the first dose of study drug;
- Nonsterilized men must agree to use highly effective contraception for the duration of the study and for ≥ 120 days after study drug administration;
- Life expectancy greater than 3 months;
- Cohort A Specific
- Histologically confirmed Stage IIB-IIIA NSCLC (as defined by the American Joint Committee on Cancer, 8th edition);
- Confirmed eligibility for R0 resection for curative intent by thoracic surgeon assessment;
- Adequate cardiopulmonary function, confirmed to meet the requirement for surgical resection for curative intent;
- Cohort B Specific
- 1\) Histologically or cytologically confirmed locally advanced (Stage IIIA-IIIC), or metastatic (Stage IV) NSCLC not amenable to curative surgery or radiotherapy.
Exclusion
- Patients with EGFR mutation, ALK gene rearrangement or ROS1 gene rearrangement:
- For patients with non-squamous cell carcinoma, if EGFR mutation status is unknown, tissue samples should be provided for local or central laboratory testing before enrollment;
- For patients with squamous cell carcinoma, if EGFR mutation status is unknown, it is not required to conduct test at screening;
- Testing at screening is not required if ALK gene rearrangement or ROS1 gene rearrangement status is unknown;
- Allergic to any study drug or excipients;
- Patients who have been treated with immune checkpoint inhibitors such as anti-PD-1, PD-L1 or CTLA-4 therapy;
- Cohort A: patients who have received systemic platinum-based doublet chemotherapy; Cohort B: patients who have received systemic platinum-based doublet chemotherapy as advanced systemic therapy;
- Patients received other approved systemic anticancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin 2, and tumor necrosis factor) 4 weeks before the first dose;
- Cohort B: patients with refractory pleural effusion or ascites, such as pleural effusion or ascites requiring puncture and drainage 2 before the first dose;
- Cohort B: Patients with active leptomeningeal disease or brain metastasis, such as central nervous system symptoms, requiring interventional therapy (including but not limited to radiotherapy, intracranial pressure lowering therapy, etc.);
- Patients with any disease requiring systemic treatment with corticosteroids (daily dose of prednisone or equivalent \> 10 mg) or other immunosuppressive drugs 14 days before grouping; Note: epinephrine replacement steroids (daily dose of prednisone ≤ 10 mg or equivalent) are allowed;Inhaled corticosteroids with minimal intranasal or systemic absorption; prophylactic use of prescription corticosteroids (eg, for contrast medium allergy) for short duration (≤ 7 days) or for treatment of non-autoimmune diseases (eg, delayed hypersensitivity reaction to contact allergens) is permitted;
- Active autoimmune disease or history of autoimmune disease that may recur; Note: well-controlled type 1 diabetes is allowed; hypothyroidism (controlled with thyroid hormone replacement only); well-controlled celiac disease; skin disease not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia); any other condition that is not expected to recur in the absence of an external trigger.
- History of interstitial lung disease, pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease;
- 4\. Serious infection occurred before grouping, including but not limited to hospitalization due to infectious complications, bacteremia or severe pneumonia; severe chronic or active infection (including pulmonary tuberculosis infection, etc.) requiring systemic (oral or intravenous) antibiotics within 14 days before grouping;
- HBV deoxyribonucleic acid (DNA) must be \< 500 IU/mL (or 2500 copies/mL) in inactive/asymptomatic carriers, patients with chronic or active hepatitis B virus (HBV) at screening Note: Patients with detectable hepatitis B surface antigen (HBsAg) or detectable HBV DNA should be treated according to treatment guidelines. Patients receiving antiviral therapy at screening should be treated \> 2 weeks prior to screening.
- Any major surgery requiring general anesthesia ≤ 28 before the first dose;
- Presence of underlying medical conditions or alcohol/drug abuse or dependence that would impair the administration of the study drug, or that could affect the interpretation of the results, or result in a high risk of treatment complications;
- Simultaneous participation in another therapeutic clinical study;
- Pregnant or lactating women, or male and female patients planning to have children during the study;
- Other conditions that the investigators consider inappropriate for participation in this trial, such as poor compliance.
Key Trial Info
Start Date :
December 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05244837
Start Date
December 22 2020
End Date
December 1 2023
Last Update
February 17 2022
Active Locations (4)
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1
Guangzhou Medical University Affiliated Cancer Hospital
Guangzhou, Guangdong, China
2
Sun Yat-sen University cancer center
Guangzhou, Guangdong, China
3
Jiangmen Central Hospital
Jiangmen, Guangdong, China
4
Guangzhou panyu central hospital
Guangzhou, China