Study to Evaluate the Bioavailability of Tislelizumab Via Subcutaneous Injection in First-Line Treatment of Participants With Advanced or Metastatic Non-Small Cell Lung Cancer

BeiGene

Status and phase: Active, not recruiting; Phase 1

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Tislelizumab SC; Drug: Tislelizumab IV; Drug: Histology-Based Chemotherapy Doublet

Study type: Interventional

Funder types: Industry

Identifiers

NCT06091943

BGB-A317-103

CTR20233814 (Registry Identifier)

Details and patient eligibility

About

This is an open-label, multicenter, Phase 1 clinical study to evaluate the bioavailability of tislelizumab subcutaneous (SC) injection in the first-line treatment of participants with advanced or metastatic non-small cell lung cancer (NSCLC). This clinical study will be divided into 2 parts: dose/injection site exploration (Part 1) and dose expansion (Part 2).

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to sign a written consent form, understand, and agree to comply with requirements of the study.
• Documented locally advanced or recurrent NSCLC that is not eligible for curative surgery and/or definitive radiotherapy, with or without chemotherapy, or metastatic non-squamous or squamous NSCLC.
• No prior systemic treatment for advanced or metastatic NSCLC, including but not limited to chemotherapy or targeted therapy.
• At least one measurable lesion as assessed by RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) PS ≤ 1.
• Adequate organ function as indicated by laboratory tests.

Exclusion criteria

• Participants diagnosed with NSCLC that harbor a driver mutation (eg, EGFR-sensitizing mutation, ALK fusion oncogene, and BRAF V600E mutation or ROS1 mutation).
• Participant has received any Chinese herbal medicine or Chinese patent medicines used to control cancer within 14 days before first dose of study drug.
• Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
• Active autoimmune diseases or history of autoimmune diseases that may relapse.
• Any cancer ≤ 5 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, localized prostate cancer, carcinoma in situ of the cervix or breast).
• Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before first dose of study drug.

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

62 participants in 2 patient groups

Part 1: Dose/Injection Site Exploration

Experimental group

Description:

Different injection sites will be evaluated; participants will receive tislelizumab in predefined administration sequences plus histology-based chemotherapy consisting of either cisplatin/carboplatin and pemetrexed or carboplatin and paclitaxel/nab-paclitaxel depending on the cancer subtype.

Treatment:

Drug: Histology-Based Chemotherapy Doublet

Drug: Tislelizumab IV

Drug: Tislelizumab SC

Part 2: Dose Expansion

Experimental group

Description:

The recommended dose of tislelizumab SC determined from Part 1 plus histology-based chemotherapy consisting of either cisplatin/carboplatin and pemetrexed or carboplatin and paclitaxel/nab-paclitaxel depending on the cancer subtype will be evaluated.

Treatment:

Drug: Histology-Based Chemotherapy Doublet

Drug: Tislelizumab SC