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Sacituzumab Govitecan-Hziy plus bevacizumab

Phase 2

NSCLC Stage IV | Small molecule | Other |Gilead Sciences, Inc.|Last Updated: May 6, 2025

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06401824Sacituzumab Govitecan and Bevacizumab for NSCLC Brain MetastasesPHASE2 RECRUITING 25Apr 24, 2025Apr 1, 2027May 6, 20253 Netherlands
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Study Endpoints
Primary Endpoints
brain metastases overall response rate (ORR)
up to 24 months

ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) based on central and local investigator's assessment according to RANO-BM criteria on brain MRI

Secondary Endpoints
brain metastases overall response rate (ORR) with correction for bevacizumab-pseudoresponse
up to 24 months
brain metastases disease control rate (DCR)
up to 24 months
CNS progression free survival (PFS)
up to 24 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
sacituzumab govitecan (SG) plus bevacizumabEXPERIMENTALSG 10mg/kg intravenous day 1 and day 8 of a 21-day cycle, + bevacizumab 15 mg/kg iv day 1 of a 21-day cycle till unacceptable toxicity or disease progression.
Interventions
NameTypeDescription
Sacituzumab Govitecan-Hziy 180 MG plus bevacizumabDRUGSacituzumab govitecan 10mg/kg intravenous day 1 and day 8 of a 21-day cycle, + bevacizumab 15 mg/kg iv day 1 of a 21-day cycle till unacceptable toxicity or disease progression.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Participant is an adult ≥ 18 years of age at the time of informed consent. 3. ECO...

Countries:Netherlands
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06401824studyFirstPostDate: changed