Active — Not RecruitingPhase 3

Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)

China453 participantsStarted 2020-05-29

Plain-language summary

The primary objective of this study is to evaluate and compare major pathological response(MPR) rate and event-free survival (EFS) in participants receiving tislelizumab plus platinum-based doublet chemotherapy as the new additional treatment followed by tislelizumab as adjuvant treatment versus participants receiving placebo plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by placebo as adjuvant treatment.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
✓. Histologically confirmed Stage II or IIIA NSCLC
✓. Measurable disease as assessed per RECIST v1.1
✓. Confirm eligibility for an R0 resection with curative intent

Exclusion criteria

✕. Any prior therapy for current lung cancer, including chemotherapy, or radiotherapy
✕. Known Epidermal growth factor receptor (EGFR) mutation or Anaplastic Lymphoma Kinase (ALK) gene translocation
✕. Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before randomization
✕. Active autoimmune diseases or history of autoimmune diseases that may relapse
✕. History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.

What they're measuring

Major pathological response (MPR) in Intent-to-Treat (ITT) analysis set

Timeframe: Up to 3 months following completion of neoadjuvant treatment

Event-free survival (EFS) in ITT analysis set as Assessed by the Blinded Independent Central Review (BICR)

Timeframe: Up to 5 years

Trial details

NCT IDNCT04379635

SponsorBeiGene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-21

View on ClinicalTrials.gov More Non Small Cell Lung Cancer trials