{"preliminary_commentary":{"by_channel":{"x_thread":5},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["sitravatinib","tislelizumab"]],"indication":"locally advanced or metastatic non-small cell lung cancer","name":"SAFFRON-301","nct_id":"NCT04921358","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=saffron-301-nct04921358. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"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.","label":"Tislelizumab + Sitravatinib","type":"EXPERIMENTAL"},{"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.","label":"Docetaxel","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2023-12-20","type":"ACTUAL"},"conditions":["Non-Small Cell Lung Cancer (NSCLC)"],"enrollment":{"count":377,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Tislelizumab","otherNames":["BGB-A317"],"type":"DRUG"},{"name":"Docetaxel","otherNames":[],"type":"DRUG"},{"name":"Sitravatinib","otherNames":["BGB-9468"],"type":"DRUG"}],"last_update":"2025-06-29","lead_sponsor":"BeiGene","official_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","overall_status":"TERMINATED","phases":["PHASE3"],"primary_completion_date":{"date":"2023-12-20","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Survival (OS)","timeFrame":"Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months)."},{"measure":"Progression Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)","timeFrame":"Until the study completion data cut-off date of December 20, 2023, or the last available date confirming participants were alive (a median follow-up of approximately 8 months)."}],"references":[{"citation":"Zhou Q, Zhao J, Gao B, et al. SAFFRON-301: A Phase 3 Study of Tislelizumab With Sitravatinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy and an Anti-PD-1/PD-L1 Antibody. Poster presented at: ESMO Congress 2022; September, 2022; Paris, France.","pmid":null,"type":"BACKGROUND"},{"citation":"Zhou Q, Gao B, et al. SAFFRON-301: Sitravatinib PLUS Tislelizumab in Advanced/Metastatic NSCLC Progressing on/after Chemotherapy and Anti-PD-(L)1.","pmid":null,"type":"RESULT"},{"citation":"Zhou Q, Gao B, Hu J, Zhao J, Wang M, He K, Zhang W, Liu C, Fang J, Li XY, Wang Z, Matos M, Kwatra V, Zheng W, Wang C, Chen Y, Zhang J, Wang J, Wu YL. SAFFRON-301: a randomised phase III study of sitravatinib in combination with tislelizumab in patients with locally advanced or metastatic non-small cell lung cancer. BMJ Oncol. 2026 Feb 19;5(1):e000890. doi: 10.1136/bmjonc-2025-000890. eCollection 2026.","pmid":"41737914","type":"DERIVED"}],"start_date":{"date":"2021-07-27","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","url":"https://clinicaltrials.gov/study/NCT04921358"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/saffron-301-nct04921358"}