Study of Tislelizumab for Locally Advanced Non-Small Cell Lung Cancer Following Neoadjuvant Chemotherapy Plus Tislelizumab ± Bevacizumab and Definitive Concurrent Chemoradiation Therapy

Sponsor
Sun Yat-sen University
Study ID
NCT05468242
Phase
PHASE2
Status
Recruiting
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Conditions

  • Stage III Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Neoadjuvant chemo-immunotherapy — DRUG
    The neoadjuvant chemo-immunotherapy before radiotherapy comprised of chemotherapy plus Tislelizumab \[200 mg, once every 3 weeks (Q3W)\].
  • Bevacizumab — DRUG
    The Bevacizumab was administrated concurrently with neoadjuvant chemo-immunotherapy (7.5mg/kg) once every 3 weeks (Q3W).
  • Radiotherapy — RADIATION
    Definitive radiotherapy to the thoracic lesions.
  • Tislelizumab — DRUG
    Tislelizumab consolidation (200 mg) is performed once every 3 weeks after the neoadjuvant therapy and concurrent chemo-radiotherapy, and will continue on a Q3W schedule for a maximum duration of 12 months.

Study Details

The phase II Study is to explore the efficacy and safety of Tislelizumab as consolidation therapy in patients with locally advanced non-small cell lung cancer who have not progressed following neoadjuvant chemotherapy plus Tislelizumab ± Bevacizumab and definitive concurrent chemoradiation therapy.

Key Dates

First listed
Jul 21, 2022
Start date
Jan 1, 2022
Status verified
Oct 2024
Primary completion
Dec 30, 2024
Completion
Dec 30, 2024

Study Design

Enrollment
116 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant Chemotherapy Plus Tislelizumab + Bevacizumab
    Patients in experimental group will receive Tislelizumab consolidation (200 mg/q3w) after the neoadjuvant chemotherapy plus Tislelizumab + Bevacizumab and concurrent chemoradiotherapy.
  • Active Comparator: Neoadjuvant Chemotherapy Plus Tislelizumab
    Patients in this group will receive Tislelizumab consolidation (200 mg/q3w) after the neoadjuvant chemotherapy plus Tislelizumab and concurrent chemoradiotherapy.

Primary Outcome Measure

Progression free survival [ Time Frame: 2-year ]

Central Contacts

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