A Study of Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer

BeiGene

Status and phase: Completed; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Nab-paclitaxel; Drug: Carboplatin; Drug: Paclitaxel; Drug: Tislelizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03594747

BGB-A317-307

CTR20180292 (Registry Identifier)

Details and patient eligibility

About

An open-label, randomized, multicenter Phase 3 study designed to compare the efficacy and safety of tislelizumab combined with chemotherapy versus chemotherapy only as first-line treatment in advanced squamous non-small cell lung cancer (NSCLC).

Enrollment: 360 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Age 18-75 years old, male or female, and signed informed consent form (ICF)
2. Advanced NSCLC diagnosed by pathological or clinical physicians
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
4. Participants must have ≥ 1 measurable lesion as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
5. Must be treatment-naive for locally advanced or metastatic squamous NSCLC
6. Life expectancy ≥ 12 weeks
7. Participants must have adequate organ function
8. Male/Female is willing to use a highly effective method of birth control

Key Exclusion Criteria:

1. Diagnosed with NSCLC but with epidermal growth factor receptors (EGFR)-sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation
2. Received any approved systemic anticancer therapy
3. Received prior treatment with EGFR inhibitors or ALK inhibitors
4. Received prior therapies targeting programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1)
5. With history of interstitial lung disease
6. Clinically significant pericardial effusion
7. Severe infections, active leptomeningeal disease or uncontrolled, untreated brain metastasis
8. Any major surgical procedure before randomization
9. Human immunodeficiency virus infection
10. Untreated hepatitis B virus (HBV)/hepatitis C virus (HCV)
11. Active autoimmune diseases or history of autoimmune diseases
12. History of allergic reactions to chemotherapy

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 3 patient groups

Tislelizumab + Paclitaxel + Carboplatin

Experimental group

Description:

Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)

Treatment:

Drug: Tislelizumab

Drug: Paclitaxel

Drug: Carboplatin

Tislelizumab + Nab-paclitaxel + Carboplatin

Experimental group

Description:

Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)

Treatment:

Drug: Tislelizumab

Drug: Carboplatin

Drug: Nab-paclitaxel

Paclitaxel + Carboplatin

Active Comparator group

Description:

Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)

Treatment:

Drug: Paclitaxel

Drug: Carboplatin