Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

BeiGene

Status and phase: Terminated; Phase 3

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Treatments: Drug: Docetaxel; Drug: Tislelizumab; Drug: Sitravatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04921358

BGB-A317-Sitravatinib-301

SAFFRON-301 (Other Identifier)

CTR20211410/CTR20211409 (Other Identifier)

2022-001779-15 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study was to evaluate the efficacy and safety of tislelizumab in combination with sitravatinib compared to docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who experienced disease progression following platinum-based chemotherapy and anti-programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) antibody treatment, with the anti-PD-(L)1 antibody administered either in combination with or sequentially before or after the platinum-based chemotherapy.

Enrollment: 377 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Metastatic or unresectable locally advanced histologically or cytologically confirmed Non-Small Cell Lung Cancer (NCSLC), not amenable to treatment with curative intent
2. Able to provide archival/fresh tumor tissues for biomarker analysis to assess PD-L1 expression and other biomarkers.
3. No known Epidermal Growth Factor Receptor (EGFR) or B-Raf proto-oncogene (BRAF) sensitizing mutation, or anaplastic lymphoma kinase (ALK) rearrangement or ROS proto oncogene 1 (ROS1) rearrangement
4. Radiographic progression per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 on or after anti-PD-(L)1 containing therapy for locally advanced and unresectable or metastatic NSCLC.
5. No prior anticancer therapy having the same mechanism of action as sitravatinib (eg, tyrosine kinase inhibitor with a similar target profile or vascular endothelial growth factor (VEGF)- or VEGFR inhibitor)
6. At least 1 measurable lesion as defined based on RECIST v1.1 by investigator

Key Exclusion Criteria:

1. Has received docetaxel as monotherapy or in combination with other therapies.
2. Squamous NSCLC with central cavitation, or NSCLC with hemoptysis (> 50 mL/day)
3. Participants with tumor shown by imaging to be located around important vascular structures or if the investigator determines that the tumor is likely to invade important blood vessels and may cause fatal bleeding.
4. Active leptomeningeal disease for metastatic NSCLC, or uncontrolled or untreated brain metastasis.
5. Active autoimmune diseases or history of autoimmune diseases that may relapse.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

377 participants in 2 patient groups

Tislelizumab + Sitravatinib

Experimental group

Description:

Participants received 200 mg of intravenous tislelizumab every 3 weeks, combined with 100 mg of oral sitravatinib daily until disease progression, intolerable toxicity, death, or withdrawal of consent, whichever occurred earlier.

Treatment:

Drug: Sitravatinib

Drug: Tislelizumab

Docetaxel

Active Comparator group

Description:

Participants received 75 mg/m² of intravenous docetaxel once every 3 weeks until disease progression, intolerable toxicity, death, or withdrawal of consent, whichever occurred earlier.

Treatment:

Drug: Docetaxel