Health Condition 1: C159- Malignant neoplasm of esophagus, unspecified Health Condition 2: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Tislelizumab: Injection- 100 mg/10 mL (10 mg/mL)
200 mg administered as an intravenous infusion once every 3 weeks (15 cycles).
Control Intervention1: Not applicable: Not applicable
Sponsors
Glenmark Pharmaceuticals Ltd
Clinical Research Network India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged more than and equal to 18 years with histologically confirmed diagnosis of ESCC as 2nd line after prior systemic chemotherapy or NSCLC without driver mutations as 1st line or 2nd line after prior systemic chemotherapy a. irrespective of PD-L1 status for ESCC and squamous NSCLC b. PD-L1 expression more than or equal to 50 percent for non squamous NSCLC 2. Participants must have less than or equal to 1 measurable lesion as defined per Response Evaluation Criteria in Solid Tumours RECIST v1.1 3. Eastern Cooperative Oncology Group performance status of 0 to 2 4. Willing to provide signed informed consent form
Exclusion criteria
Exclusion criteria: Main criteria for exclusion: 1. Received prior therapies including those targeting PD-1, PD-L1, CTLA-4 based immunotherapy for advanced or metastatic disease. 2. Patients with driver mutations (EGFR, ROS, ALK etc.) 3. Received prior anti-cancer therapy including investigational agent within 4 weeks, or completed palliative radiotherapy within 7 days, prior to enrolment for patients enrolled for 2L treatment 4. History of severe hypersensitivity reactions to other monoclonal antibodies or any contraindication to the planned chemotherapy regimen. 5. Severe hypersensitivity to any excipient of Tislelizumab. 6. Participants with autoimmune diseases or history of autoimmune diseases at high risk for relapse 7. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (exceeding 10 mg daily dose of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment 8. Known history of HIV or patients with active/symptomatic carrier or chronic hepatitis B virus (HBV). 9. History of interstitial lung disease or non-infections pneumonitis. 10. Any other medical conditions/ risk factors which is deemed unsuitable to receive Tislelizumab therapy as per Investigator s discretion. 11. Pregnant or lactating females 12. Concurrent participation in another therapeutic clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety of patients with ESCC or NSCLC in India treated with Tislelizumab in terms of - 1. Number of patients with any treatment related adverse events (TRAEs). 2. Number of patients with any treatment emergent adverse events (TEAEs) 3. Number of patients with Serious TEAEs (STEAE) 4. Number of patients with any immune related adverse events (irAEs) 5. AEs/SAEs leading to interruption or discontinuation of TislelizumabTimepoint: 1. TRAEs [Time frame: up to 12 months] 2. TEAEs [Time Frame: up to 12 months] 3. STEAE [Time Frame: up to 12 months] 4. irAEs [Time Frame: up to 12 months] 5. AEs/SAEs leading to interruption or discontinuation of Tislelizumab [Time Frame: up to 12 months] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression free survival (PFS) defined as the time from the date of enrolment to the date of first documented progressive disease (PD), based on investigator s assessment per RECIST v1.1 2. Overall Survival (OS) rate defined as the time from the date of enrolment until the date of death due to any cause 3. Objective Response rate (ORR) defined as the percentage of participants with confirmed complete response (CR) and partial response (PR) as assessed by investigator per RECIST v1.1 4. Duration of response (DoR) defined as the time from the first determination of an objective response until the first documentation of progression or death, whichever is first as assessed by the investigator per RECIST v1.1, or death, whichever comes first 5. Health-Related Quality of Life (HRQoL) as assessed by QLQ-LC13 for NSCLC patients & QLQESCC18 for ESCC patientsTimepoint: 1. Progression free survival (PFS) [Timeframe: 3, 6 and 12 months] 2. Overall Survival (OS) rate [Timeframe: 3, 6 and 12 months] 3. Objective Response rate (ORR) [Timeframe: 3, 6 and 12 months] 4. Duration of response (DoR) [Timeframe: Upto 12 months] 5. Health-Related Quality of Life (HRQoL) [Timeframe: 3, 6, 9 and 12 months] | — |
Countries
India
Contacts
Public ContactDr Nidhi Singh
Glenmark Pharmaceuticals Ltd.
Outcome results
None listed