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Experimental

Phase 2

NSCLC | Small molecule | Other |Third Harmonic Bio, Inc.|Last Updated: Mar 25, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07138755The Efficacy and Safety of the Combination of PD-1 With Chemotherapy and Adaptive Radiotherapy Strategy in the Treatment of Stage III Non-small Cell Lung Cancer PatientsPHASE2 RECRUITING 35Aug 29, 2025Sep 1, 2030Mar 25, 20261 China
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Study Endpoints
Primary Endpoints
Progression-Free Survival (PFS)
28 months

The time from the beginning of treatment to the time when the disease progresses or the patient dies from any cause

Secondary Endpoints
Objective Response Rate (ORR)
28 months
Disease Control Rate (DCR)
28 months
Overall Survival (OS)
28 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
adaptive radiotherapy strategyEXPERIMENTALAfter two cycles of sintilimab and platinum based chemotherapy, receive two additional courses of sintilimab and platinum based chemotherapy and adaptive radiotherapy strategy
Interventions
NameTypeDescription
ExperimentalDRUGDrug: Sintilimab, 200mg IV D1 Q3W, Cisplatin, 75mg/m2 D1 IV Q3W or Carboplatin AUC 5 D1 IV Q3W, Paclitaxel or Paclitaxel liposome 135-175mg/m2 D1 IV Q3W(Squamous) Drug: Sintilimab, 200mg IV D1 Q3W, Cisplatin, 75mg/m2 D1 IV Q3W or Carboplatin AUC 5 D1 IV Q3W, Pemetrexed, 500mg/m2 D1 IV Q3W(adenocarcinoma) Radiation:Adaptive radiotherapy with V20\<20%: 1.PGTV60-66Gy/2.0-2.2Gy/30F;PTV54Gy/1.8Gy/30F;2.PGTV54-66Gy/2.0-2.2Gy/30F;3.PGTV50Gy/2.0Gy/25F
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study 2. Age range of 18-75 years old upon enrollment, both male and female are eligible 3. Stage III NSCLC confirmed by histology or cytolo...

Countries:China
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07138755studyFirstPostDate: changed