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Closed (no longer recruiting)Last updated: 5 February 2024

BGB-301: This phase III trial will evaluate the combination of two types of targeted therapy to determine if it will be safe and effective to treat people that have been diagnosed with locally advanced or metastatic non-small cell lung cancer that has progressed (got worse) following previous chemotherapyA Randomized Phase 3 Study of Tislelizumab in Combination With Sitravatinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Progressed on or After Platinum-Based Chemotherapy and Anti-PD-(L)1 Antibody

Clinical summary


People that are eligible to join this trial will be randomly allocated into one of two arms. In the experimental arm (Arm A), participants will receive 200mg intravenous tislelizumab once every three weeks, in combination with 100mg oral sitravatinib once a day. In the comparator arm (Arm B), participants will receive 75mg/m2 intravenous docetaxel once every three weeks. In both arms of the trial, treatment will be administered until progressive disease or intolerable toxicity.


This trial is treating patients with non-small cell lung cancer.


Lung Cancers Lung cancer





Trial Acronym


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Trial Identifiers

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Trial sponsor

BeiGene Australia Pty Ltd

Scientific Title

A Randomized Phase 3 Study of Tislelizumab in Combination With Sitravatinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Progressed on or After Platinum-Based Chemotherapy and Anti-PD-(L)1 Antibody



  1. Metastatic or unresectable locally advanced histologicallyor 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


  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.


  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.


  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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