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

BeiGene

Status and phase: Active, not recruiting; Phase 3

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Placebos; Drug: Tislelizumab; Drug: Pemetrexed Disodium; Drug: Cisplatin injection; Drug: Paclitaxel injection; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04379635

CTR20200821 (Registry Identifier)

BGB-A317-315

Details and patient eligibility

About

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.

Enrollment: 453 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

453 participants in 2 patient groups, including a placebo group

Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab

Experimental group

Description:

Tislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium

Treatment:

Drug: Carboplatin

Drug: Paclitaxel injection

Drug: Cisplatin injection

Drug: Pemetrexed Disodium

Drug: Tislelizumab

Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo

Placebo Comparator group

Description:

Placebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium

Treatment:

Drug: Carboplatin

Drug: Paclitaxel injection

Drug: Cisplatin injection

Drug: Pemetrexed Disodium

Drug: Placebos