Tislelizumab Combined With Sitravatinib as Consolidation Treatment Following Concurrent Chemoradiation in Patients With Locally Advanced, Unresectable NSCLC

NCT05176925 | Terminated Phase 2

• 1 other identifier: 2111245-17
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the 1-year progression free survival (PFS) rate of tislelizumab combined with sitravatinib as assessed by investigators per RECIST 1.1.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 1-year Progression-Free-Survival (PFS) rate assessed by investigators per RECIST 1.1

  PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause.

  Start of treatment until 1-year follow-up

Secondary Outcomes (7)

• PFS (Progression-Free-Survival)

  Up to 4 years

• Objective Response Rate (ORR)

  Up to 4 years

• Duration of Response (DOR)

  Up to 4 years

• DCR (Disease Control Rate)

  Up to 4 years

• OS (Overall Survival)

  From date of treatment start until the date of death from any cause or censored at the last day that the subjects are documented to be alive, whichever came first, assessed up to 4 years.

Study Arms (1)

Tislelizumab combined with sitravatinib

EXPERIMENTAL

Drug: Tislelizumab; Drug: Sitravatinib

Interventions

Tislelizumab DRUG

Tislelizumab 200mg IV D1, Q3W

Tislelizumab combined with sitravatinib

Sitravatinib DRUG

The starting dose of sitravatinib in this study is 70 mg, oral once daily. After receiving 2 cycles of starting dose at 70 mg once daily with sitravatinib, if patients were tolerated well with study treatment (without AEs definitely related to sitravatinib nor TRAEs leading to sitravatinib dose reduction and interruption), it is recommended to escalate sitravatinib dose to 100 mg once daily at the discretion of the investigators after discussion with patients.

Tislelizumab combined with sitravatinib

Eligibility Criteria

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

You may qualify if:

• ECOG performance status≤1.
• Life expectancy ≥ 3 months.
• Eligible patients for this study must have locally advanced, Stage III NSCLC that is considered unresectable. histologically- or cytologically-documented NSCLC who present with locally advanced, unresectable (Stage III) disease (according to Version 8 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology). Patients must not have progressed following definitive, platinum-based, concurrent chemoradiation therapy.
• First dose of study treatment is no later than 42 days after cCRT.
• Adequate organ function as indicated by the following laboratory values (obtained ≤ 7 days before first dose)
• Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L,
• Platelets ≥ 100 × 10\^9/L,
• Hemoglobin ≥ 90 g/L.
• International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x upper limit of normal (ULN).
• Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN.
• Serum total bilirubin ≤ 1.5 x ULN.
• Aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 x ULN.
• Serum albumin ≥25 g/L（2.5 g/dL).
• Serum creatinine ≤ 1.5 x ULN or estimated glomerular. filtration rate (GFR) \>50 mL/min by Cockcroft-Gault equation.
• Able to provide written informed consent by the patient or by the patient's legally acceptable representative and can understand and agree to comply with the requirements of the study.

You may not qualify if:

• Mixed small cell and non-small cell lung cancer histology.
• Received prior anti-VEGF mAb or VEGFR TKI agents and prior therapies targeting PD-1, PD-L1, CTLA-4 or other immune checkpoints.
• Have any unresolved AE≥Grade 2 from prior cCRT，radiotherapy induced hearing loss, hair loss, peripheral sensory neuropathy and fatigue is excluded.
• Grade ≥2 radiation pneumonitis while receiving cCRT.
• Patients with known EGFR mutation, or ALK or ROS1 rearrangement.
• Treatment with any approved systemic anti-cancer therapy or systemic immune-stimulatory agents (including but not limited to interferons, interleukin IL-2, and tumor necrosis factor) within 4 weeks prior to initiation of study treatment.
• Administration of live vaccine ≤ 4 weeks before the first dose of study treatment.
• History of allergic reactions to any study drugs.
• Patients with untreated chronic hepatitis B (HBV) or chronic HBV carriers whose HBV DNA ≥ 500 IU/mL, patients with active hepatitis C (HCV).
• Active autoimmune diseases that require treatment and may affect study treatment estimated by investigator.
• Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or any other immunosuppressive medication≤ 14 days before first dose of study drugs that may affect study treatment estimated by investigator.
• Severe chronic or active infections requiring systemic antibacterial, antifungal, within 14 days prior to first dose of study drug(s).
• Prior allogeneic stem cell transplantation or organ transplantation.
• Any of the following cardiovascular risk criteria:
• Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before first dose of study drugs.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

tislelizumab; sitravatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zhengfei Zhu, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

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: Professor

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 4, 2022
• Study Start: January 10, 2021
• Primary Completion: June 27, 2022
• Study Completion: September 28, 2022
• Last Updated: January 29, 2024

Record last verified: 2024-01

Locations

CN (1)