{"preliminary_commentary":{"by_channel":{"x_thread":4,"podcast":1},"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":[["serplulimab","bevacizumab"],["serplulimab"]],"indication":"first-line advanced non-squamous NSCLC","name":"ASTRUM-002","nct_id":"NCT03952403","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=astrum-002-nct03952403. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","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 will receive IV infusion of HLX10 and HLX04 on Day 1 of each 21-day cycle followed by IV infusion of Carboplatin and Pemetrexed on Day 1 of each 21-day cycle for 4 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants will receive IV infusion of HLX10 until loss of clinical benefit and HLX04 and Pemetrexed until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.","label":"Part 1-Cohort 1 (HLX10+HLX04+Carboplatin+Pemetrexed)","type":"EXPERIMENTAL"},{"description":"Participants will receive IV infusion of HLX10 and HLX04 on Day 1 of each 21-day cycle followed by IV infusion of Carboplatin and Pemetrexed on Day 1 of each 21-day cycle for 4 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants will receive IV infusion of HLX10 until loss of clinical benefit and HLX04 and Pemetrexed until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.","label":"Part 2-Arm A (HLX10+HLX04+Carboplatin+Pemetrexed)","type":"EXPERIMENTAL"},{"description":"Participants will receive IV infusion of HLX10 and HLX04 placebo on Day 1 of each 21-day cycle followed by IV infusion of Carboplatin and Pemetrexed on Day 1 of each 21-day cycle for 4 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants will receive IV infusion of HLX10 until loss of clinical benefit and Pemetrexed until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.","label":"Part 2-Arm B (HLX10+HLX04 placebo+Carboplatin+Pemetrexed)","type":"EXPERIMENTAL"},{"description":"Participants will receive IV infusion of HLX10 placebo and HLX04 placebo on Day 1 of each 21-day cycle followed by IV infusion of Carboplatin and Pemetrexed on Day 1 of each 21-day cycle for 4 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants will receive IV infusion Pemetrexed until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.","label":"Part 2-Arm C (HLX10 placebo+HLX04 placebo+Carboplatin+Pemetrexed)","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2024-03-15","type":"ESTIMATED"},"conditions":["Carcinoma","Non-Small-Cell Lung"],"enrollment":{"count":643,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"HLX10, an engineered anti-PD-1 antibody","otherNames":[],"type":"DRUG"},{"name":"HLX04, a bevacizumab biosimilar","otherNames":[],"type":"DRUG"},{"name":"Carboplatin","otherNames":[],"type":"DRUG"},{"name":"Pemetrexed","otherNames":[],"type":"DRUG"}],"last_update":"2023-08-08","lead_sponsor":"Shanghai Henlius Biotech","official_title":"A Three Arm, Randomized, Double-Blind, Multicenter, Phase 3 Study of HLX10(Anti-PD-1 Antibody) in Combination With Carboplatin Plus (+) Pemetrexed With or Without HLX04(Avastin Biosimilar) Compared With Carboplatin+Pemetrexed in 1L Stage IIIB/IIIC or IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)","overall_status":"UNKNOWN","phases":["PHASE3"],"primary_completion_date":{"date":"2023-10-01","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Part 1 Safety and tolerability of study treatment","timeFrame":"baseline to 21 days"},{"measure":"Part 2-Progression Free Survival (PFS) as Determined by the IRRC using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)","timeFrame":"Baseline until disease progression or death, whichever occurs first (up to approximately 24months)"}],"references":[{"citation":"Hao X, Wang L, Hao Y, Hu Y, Chen C, Chen B, Huang Y, Zang A, Wang Y, Chen Z, Zhuang W, Shi J, Ren X, Nie L, Yu G, Luo F, Mao Y, Wang X, Li B, Bai Y, Shi J, Ni H, Hou X, Yu H, Li J, Wang Q, Zhu J, Shi Y; ASTRUM-002 Study Group. Serplulimab Plus Chemotherapy, with or without HLX04, versus Chemotherapy as First-Line Treatment for Nonsquamous NSCLC: Final Survival Analysis of the Phase III ASTRUM-002 Study. Cancer Commun (Lond). 2026 Jun 10;46:0034. doi: 10.34133/cancomm.0034. eCollection 2026.","pmid":"42282892","type":"DERIVED"},{"citation":"Wang L, Hao X, Hao Y, Hu Y, Chen C, Chen B, Huang Y, Zang A, Wang Y, Chen Z, Zhuang W, Shi J, Ren X, Nie L, Yu G, Luo F, Mao Y, Wang X, Li B, Bai Y, Shi J, Ni H, Yu H, Li J, Wang Q, Zhu J, Shi Y; ASTRUM-002 Study Group. First-line serplulimab plus chemotherapy with or without HLX04 versus chemotherapy in locally advanced or metastatic non-squamous non-small-cell lung cancer (ASTRUM-002): a randomised, double-blind, multicentre phase 3 trial. Lancet Respir Med. 2026 Feb;14(2):117-128. doi: 10.1016/S2213-2600(25)00263-2. Epub 2025 Dec 4.","pmid":"41354044","type":"DERIVED"},{"citation":"Wang K, Shen Y, Hu C, Xu F, Wang Q, Gao Y, Zhou L. Population Pharmacokinetics and Exposure-Response Analysis of Serplulimab in Small Cell Lung Cancer Patients. Clin Transl Sci. 2025 Sep;18(9):e70322. doi: 10.1111/cts.70322.","pmid":"40932107","type":"DERIVED"}],"start_date":{"date":"2019-12-02","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of HLX10 in Combination With Carboplatin Plus (+) Pemetrexed With or Without HLX04 Compared With Carboplatin+Pemetrexed in 1L Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC)","url":"https://clinicaltrials.gov/study/NCT03952403"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/astrum-002-nct03952403"}