Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07005336 | A Study to Compare Uliledlimab Combined With Sintilimab and Chemotherapy Versus Sintilimab Combined With Chemotherapy in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer | PHASE2 | ACTIVE NOT_RECRUITING | 150 | — | — | Jan 9, 2025 | Jan 9, 2029 | Jan 30, 2026 | 28 | China |
| NCT06984588 | A Study to Compare Uliledlimab Combined With Toripalimab, Toripalimab Monotherapy, and Pembrolizumab Monotherapy in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1- and CD73- Selected Non-Small Cell Lung Cancer | PHASE2 | ACTIVE NOT_RECRUITING | 450 | — | — | Mar 28, 2024 | Sep 30, 2028 | Jan 30, 2026 | 64 | China |
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Non-squamous Squamous |
| Group B | EXPERIMENTAL | Non-squamous Squamous |
| Group C | SHAM_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Uliledlimab | DRUG | 30 mg/kg, administered on Days 1 and 8 of Cycle 1 (C1D1 and C1D8), then once every 3 weeks (Q3W) starting from C2D1,at most 35 cycles |
| Sintilimab | DRUG | Intravenous infusion at a recommended dose of 200 mg once every 3 weeks，at most 35 cycles |
| Pemetrexed | DRUG | Intravenously at a recommended dose of 500 mg/m2 body surface area (BSA) ,once every 3 weeks until the disease progresses. |
| Gemcitabine | DRUG | 1000 mg/m2, administered on Days 1 and 8 ,once every 3 weeks (Q3W) for 4 cycles |
| Cisplatin Or Carboplatin | DRUG | Cisplatin: 5 mg/m2 administered intravenously every 3-4 weeks for 4 cycles Carboplatin:75 mg/m2, administered intravenously every 3-4 weeks for 4 cycles |
| Toripalimab | DRUG | 240 mg on Day 1, once every 3 weeks (Q3W) |
| Pembrolizumab | DRUG | 200 mg on Day 1, once every 3 weeks (Q3W) |
Inclusion Criteria: 1. Patients aged ≥ 18 years at the time of signing the ICF. 2. Patients with histologically or cytologically confirmed stage IIIB, IIIC, or IV NSCLC who are not suitable for radical surgery and/or radiotherapy. 3. Patients who have not received prior systemic therapy for their l...