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benmelstobart

Phase 2

SCLC, Extensive Stage | Small molecule | Other |China Pharma Holdings, Inc.|Last Updated: Apr 20, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment33
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07538271A Study of Benmelstobart, Anlotinib, Chemotherapy and Thoracic Radiotherapy for People With Extensive-stage Small Cell Lung CancerPHASE2 NOT YET_RECRUITING 33 — — Apr 20, 2026Mar 31, 2029Apr 20, 2026 - —
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Study Endpoints
Primary Endpoints
Objective Response Rate (ORR)
Baseline at screening, after every 2 treatment cycles (each cycle is 21 days), end of treatment, up to disease progression, assessed up to approximately 24 months

Investigator-assessed ORR per RECIST 1.1 in ES-SCLC patients treated with benmelstobart plus anlotinib and chemotherapy followed by thoracic radiotherapy.

Secondary Endpoints
Progression-Free Survival (PFS)
Date of first study treatment to date of disease progression or death from any cause, last follow-up, assessed up to approximately 24 months
Overall Survival (OS)
From date of first study treatment to date of death from any cause or last follow-up, whichever occurs first, assessed up to approximately 24 months
6-Month Progression-Free Survival Rate
6-month time point after first treatment, follow-up cutoff
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Benmelstobart + Anlotinib + Chemotherapy Followed by Thoracic RadiotherapyEXPERIMENTALEligible patients receive 4 cycles of induction therapy (benmelstobart 1200mg IV D1 + anlotinib 12mg PO QD 2w-on/1w-off + carboplatin/cisplatin + etoposide). Non-progressive patients proceed to consolidative thoracic radiotherapy (2Gy/fraction, 25-30 fractions), followed by maintenance therapy with benmelstobart + anlotinib until disease progression or unacceptable toxicity.
Interventions
NameTypeDescription
benmelstobartDRUGA PD-L1 inhibitor (biological product) administered intravenously. Used for immunotherapy in combination with other agents to treat extensive-stage small cell lung cancer (ES-SCLC).
AnlotinibDRUGA small-molecule anti-angiogenic drug administered orally. Inhibits tumor angiogenesis to suppress tumor growth, used as part of the first-line combined therapy for ES-SCLC.
Carboplatin or cisplatinDRUGA platinum-based chemotherapeutic agent administered intravenously.
EtoposideDRUGA topoisomerase II inhibitor administered intravenously. Works by interfering with tumor cell replication, combined with platinum agents as first-line chemotherapy for ES-SCLC.
Thoracic RadiotherapyRADIATIONExternal beam radiation therapy delivered to the thoracic region. Administered as consolidative treatment for non-progressive ES-SCLC patients after induction therapy, with a total dose based on clinical practice guidelines.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * 1: Histologically or cytologically confirmed inoperable extensive-stage small cell lung cancer (ES-SCLC) according to the VALG staging system 2: No prior systemic therapy for extensive-stage small cell lung cancer (ES-SCLC) 3: Presence of measurable lesions as defined by...

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