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Iparomlimab and tuvonralimab plus chemotherapy

Phase 2

NSCLC (Non-small-cell Lung Cancer) | Small molecule | Oncology |China Pharma Holdings, Inc.|Last Updated: Aug 24, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment69
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07139041Iparomlimab and Tuvonralimab Plus Chemotherapy for Inducing Conversion to Resectability in Initially Unresectable Stage III NSCLCPHASE2 NOT YET_RECRUITING 69Oct 1, 2025Jun 1, 2029Aug 24, 2025 -
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Study Endpoints
Primary Endpoints
R0 Resection Rate
2 years

The proportion of patients who achieve complete tumor removal with no residual cancer cells at the surgical margin under microscopic examination after surgery

Secondary Endpoints
2-year event-free survival (EFS) rate
2 years
Pathologic Complete Response (pCR)
2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Iparomlimab and tuvonralimab plus chemotherapyOTHERPatients will receive Iparomlimab and tuvonralimab (5 mg/kg) plus chemotherapy (nab-paclitaxel, pemetrexed, or docetaxel) every 3 weeks.
Interventions
NameTypeDescription
Iparomlimab and tuvonralimab plus chemotherapyDRUGSquamous Cell Carcinoma: 2-4 cycles of Iparomlimab and tuvonralimab 5mg/kg Q3W (Day 1) + Albumin-bound Paclitaxel (100mg/m² Q3W D1/D8/D15 or130mg/m²D1/D8 or 260mg/m²D1) + Carboplatin (AUC=5) Q3W (D1) Non-Squamous Cell Carcinoma: 2-4 cycles of Iparomlimab and tuvonralimab 5mg/kg Q3W (D1) + Pemetrexed 500mg/m² Q3W (D1) + Carboplatin (AUC=5) Q3W (D1) Radical Chemoradiotherapy for Patients Unable to Undergo Surgery:Patients still unresectable after conversion therapy should start radical chemoradiotherapy within 6 weeks after the last conversion therapy dose. Chemoradiotherapy follows standard clinical practice, recommended as Cisplatin 30mg/m² QW (D1) + 60Gy radiotherapy. Adjuvant Therapy Phase:Iparomlimab and tuvonralimab 5mg/kg Q3W (D1) for up to 16 cycles.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Signed an informed consent form 2. Patients aged ≥18 3. Histologically or cytologically confirmed Stage III (AJCC 9th ed.) squamous or non-squamous NSCLC (mixed tumors classified by predominant cell type), deemed unresectable by the MDT team based on at least one of the follo...

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