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Uliledlimab

Phase 2

Non Small Cell Lung Cancer | Small molecule | Oncology |NovaBridge Biosciences|Last Updated: Jan 30, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment600

FDA Designations

No designations recorded

Clinical trial landscape

Uliledlimab · 2 trials · 1 indication

Phase 2 2
NCT07005336A 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 CancerNon Small Cell Lung Cancer
ACTIVE NOT_RECRUITING150 Analytics
NCT06984588A 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 CancerNon Small Cell Lung Cancer
ACTIVE NOT_RECRUITING450 Analytics
PHASE2ACTIVE NOT_RECRUITING
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
Non Small Cell Lung CancerUnlock trial analytics
PHASE2ACTIVE NOT_RECRUITING
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
Non Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free survival (PFS)
From the date of randomization to the date of first documented disease progression (assessed by a blinded independent central review [BICR] according to RECIST v1.1) or death from any cause, whichever occurs first,assessed up to 6months.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALNon-squamous Squamous
Group BEXPERIMENTALNon-squamous Squamous
Group CSHAM_COMPARATOR -

Interventions

NameTypeDescription
UliledlimabDRUG30 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
SintilimabDRUGIntravenous infusion at a recommended dose of 200 mg once every 3 weeks,at most 35 cycles
PemetrexedDRUGIntravenously at a recommended dose of 500 mg/m2 body surface area (BSA) ,once every 3 weeks until the disease progresses.
GemcitabineDRUG1000 mg/m2, administered on Days 1 and 8 ,once every 3 weeks (Q3W) for 4 cycles
Cisplatin Or CarboplatinDRUGCisplatin: 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
ToripalimabDRUG240 mg on Day 1, once every 3 weeks (Q3W)
PembrolizumabDRUG200 mg on Day 1, once every 3 weeks (Q3W)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites28

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...

Countries:China
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Competitive Landscape -Non-Small Cell Lung Cancer 391 trials (matched to "Non Small Cell Lung Cancer")

Frequently asked questions about Uliledlimab

What is Uliledlimab used for in Non Small Cell Lung Cancer?

Uliledlimab is an investigational small molecule being studied for the treatment of Non Small Cell Lung Cancer (NSCLC). It is currently in Phase 2 clinical trials for patients with previously untreated locally advanced unresectable or metastatic disease, including those selected for PD-L1 and CD73 expression.

What does Uliledlimab target?

Uliledlimab targets CD73, an enzyme involved in adenosine production that can suppress immune responses in tumors. By inhibiting CD73, the drug aims to enhance the anti-tumor activity of the immune system, particularly when combined with checkpoint inhibitors like toripalimab or sintilimab.

Who is developing Uliledlimab?

Uliledlimab is being developed by I-Mab, a biopharmaceutical company listed as I-Mab Sponsored ADR under the ticker NBP. The company is conducting Phase 2 clinical trials for this drug in Non Small Cell Lung Cancer.

What phase is Uliledlimab in?

Uliledlimab is in Phase 2 clinical development. It is not yet approved by regulatory authorities and remains an investigational drug. Two Phase 2 trials are currently active but not recruiting patients, with a combined planned enrollment of 600 participants.

What clinical trials is Uliledlimab in?

Uliledlimab is being evaluated in two Phase 2 trials. NCT06984588 compares Uliledlimab combined with toripalimab, toripalimab monotherapy, and pembrolizumab monotherapy in 450 patients with PD-L1- and CD73-selected NSCLC. NCT07005336 compares Uliledlimab combined with sintilimab and chemotherapy versus sintilimab and chemotherapy in 150 patients.

Is Uliledlimab the same as any other drug?

No, Uliledlimab is a distinct investigational drug with no alternative names listed. It is being studied as a monotherapy and in combination with other agents, but it is not known to be identical to any other approved or investigational medication.