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neoadjuvant immunotherapy

Phase 3

Non Small Cell Lung Cancer | Small molecule | Oncology |China Pharma Holdings, Inc.|Last Updated: May 29, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment201
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07608159Neoadjuvant SF-SBRT Plus Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC.PHASE3 NOT YET_RECRUITING 201May 1, 2026May 1, 2030May 29, 2026 -
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Study Endpoints
Primary Endpoints
2-year event-free survival rate
2-year event-free survival rate
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
neoadjuvant SF-SBRT followed by toripalimab and platinum-based chemotherapyEXPERIMENTALneoadjuvant SF-SBRT followed by toripalimab and platinum-based chemotherapy
toripalimab and platinum-based chemotherapyACTIVE_COMPARATORtoripalimab and platinum-based chemotherapy
Interventions
NameTypeDescription
Stereotactic body radiotherapy (SBRT)RADIATIONspatially fractionated stereotactic body radiotherapy
neoadjuvant immunotherapyDRUGToripalimab IV (dose 240mg) Q3W
Neoadjuvant ChemotherapyDRUGSquamous cell carcinoma: Paclitaxel (175mg/m²) or Docetaxel (60-75 mg/m²) or Nab-paclitaxel (260mg/m²) plus Carboplatin (AUC=5)/Cisplatin (75 mg/m²) (to be determined by researchers); Non-squamous cell carcinoma: Pemetrexed (500mg/m²) plus Carboplatin/Cisplatin (to be determined by researchers)
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Male or female participants aged 18 to 75 years; * Eastern Cooperative Oncology Group performance status of 0 or 1; * Previously untreated, pathologically confirmed, resectable or potentially -resectable stage II, IIIA, or IIIB (N2) non-small cell lung cancer according to the ...

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Competitive Landscape -Non-Small Cell Lung Cancer 406 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK25PHASE3Pembrolizumab, Olaparib, Etoposide, Carboplatin, Cisplatin
Amgen Inc.AMGN5PHASE3AMG 510, Docetaxel, ABP 234, Pembrolizumab, Sotorasib
AstraZeneca PLCAZN63PHASE3Datopotamab deruxtecan, Durvalumab, Carboplatin, Pembrolizumab, Cisplatin
Revolution Medicines, Inc.RVMD8PHASE3daraxonrasib, docetaxel, RMC-6291, Elironrasib, Daraxonrasib
Eli Lilly and CompanyLLY19PHASE3Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab
AbbVie, Inc.ABBV10PHASE3Telisotuzumab Vedotin, Docetaxel, Telisotuzumab vedotin, Telisotuzumab Adizutecan, Livmoniplimab
Bristol-Myers Squibb CompanyBMY20PHASE3Repotrectinib, Crizotinib, Nivolumab, Carboplatin, Cisplatin
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Docetaxel, PM8002, Carboplatin, Pemetrexed
Gilead Sciences, Inc.GILD4PHASE3Sacituzumab Govitecan-hziy, Docetaxel, Zimberelimab, Domvanalimab, Pembrolizumab
GSK plc Sponsored ADRGSK4PHASE3Cobolimab, Dostarlimab, Docetaxel, Belrestotug, Pembrolizumab
Johnson & JohnsonJNJ18PHASE3Lazertinib, Amivantamab, Pemetrexed, Carboplatin, Osimertinib
Pfizer Inc.PFE21PHASE3Lorlatinib, Crizotinib, Avelumab, Lorlatanib, Talazoparib
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib, Drug: Furmonertinib, Furmonertinib, JAB-21822, JAB 21822
Novartis AG Sponsored ADRNVS9PHASE3JDQ443, docetaxel, TNO155, tislelizumab, DKY709
Summit Therapeutics IncSMMT2PHASE3Ivonescimab, Pembrolizumab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib, Crizotinib, AB-106
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Pembrolizumab, Docetaxel, Rina-S, GEN1042
Incyte CorporationINCY1PHASE3Retifanlimab, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel
Regeneron Pharmaceuticals, Inc.REGN6PHASE2cemiplimab, Platinum Doublet, fianlimab, Pemetrexed, Paclitaxel
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3Tislelizumab, Cisplatin, Paclitaxel, Pemetrexed Disodium, Carboplatin
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