AzTrials
AzTrials

Non Small Cell Lung CancerPhase 2/3NCT06984588

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

A Phase 2/3 study testing Uliledlimab, Toripalimab and Pembrolizumab in people with Non Small Cell Lung Cancer, run by TJ Biopharma Co., Ltd. at 64 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a Phase II/III, randomized, open-label, active-controlled, multicenter study to compare intravenous uliledlimab combined with toripalimab, toripalimab monotherapy, and pembrolizumab monotherapy in patients with previously untreated locally advanced unresectable or metastatic PD-L1-positive (tumor proportion… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Uliledlimab, Toripalimab and Pembrolizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
450 participants
Where
64 sitesChina
Study dates
28 Mar 2024to 30 Sep 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged ≥ 18 years at the time of signing the ICF
  • Patients with histologically or cytologically confirmed stage IIIB, IIIC, or IV NSCLC (according to the American Joint Committee on Cancer Staging System, 8th edition) who are not suitable for radical surgery and/or radiotherapy (with or without chemotherapy).
  • Patients who have not received prior systemic therapy for their locally advanced or metastatic diseases.
  • Patients with measurable lesions as assessed by the investigator at the study site based on RECIST v1.1. Target lesions located in a previously irradiated region will be considered measurable only if there is documented evidence of disease progression
  • Patients with non-squamous NSCLC who are confirmed to have no EGFR-sensitive mutations or ALK fusions.
  • Patients with PD-L1 TPS ≥ 1% and CD73 TC/IC > 30% (IHC1+ or higher). It will be tested by the central laboratory for PD-L1 expression levels using the PD-L1 IHC 22C3 pharmDx assay, and CD73 expression levels using the CD73 antibody assay.
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  • Patients with a life expectancy of at least 3 months.
  • Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patients with adequate organ function
  • Patients with negative HIV testing at screening.
  • Patients with negative hepatitis B virus surface antigen (HBsAg) or inactive hepatitis B (HBsAg positive with HBV-DNA copy number ≤ ULN, ALT ≤ ULN, and no treatment is required in the investigator's opinion) at screening.
  • Patients with negative hepatitis C virus (HCV) antibody at screening, or positive HCV antibody and negative HCV RNA at screening.
  • For women of childbearing potential: A urine or serum pregnancy test must be negative within 72 hours prior to the first dose of study drug. If the urine pregnancy test result is positive or cannot be confirmed as negative, a serum pregnancy test should be performed.
  • For male subjects with female partners of childbearing potential: They must agree to use an effective method of contraception from the first dose of study drug to 180 days after the last dose of study drug.Male subjects with pregnant partners will be required to agree to use condoms; pregnant partners will not be required to use additional methods of contraception.
  • Patients who voluntarily agree to participate in the study and sign a written ICF

Who cannot join

  • Patients who are currently pregnant, breastfeeding, or planning to conceive or give birth within the expected duration of this study.
  • Patients previously treated with immune checkpoint inhibitors.
  • Patients who are receiving or have completed systemic immune agonist therapy (including but not limited to: interferon and interleukin-2) within 4 weeks prior to the first dose or 5 drug elimination half-lives (whichever is longer).
  • Patients who have received oral or intravenous antibiotic therapy within 2 weeks prior to starting study treatment, except for prophylactic use.
  • Patients who have undergone major surgery within 4 weeks prior to starting study treatment, except for diagnostic surgery.
  • Patients who have received a live attenuated vaccine within 30 days prior to starting study treatment. Seasonal influenza vaccines that do not contain live viruses are permitted.
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  • Patients who are currently participating in another clinical trial and receiving study treatment, or who have participated in a clinical trial and received investigational drug or device treatment within 4 weeks prior to enrollment.
  • Patients who have received any anti-tumor therapeutic agents containing traditional Chinese medicine ingredients within 4 weeks prior to starting study treatment.
  • Patients who have previously received an allogeneic tissue/organ transplant.
  • Patients who are expected to require any other form of anti-tumor therapy during the course of the study.
  • Patients who are receiving radiotherapy, with the exception of: 1) local radiotherapy for brain lesions, refer to exclusion criterion 22; 2) palliative radiation for bone metastases, provided that it is completed at least 7 days prior to randomization and the patient's condition is stable.
  • Patients with angina, myocardial infarction, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, unstable arrhythmia, pulmonary embolism, or treatment with percutaneous transluminal coronary angioplasty or coronary artery bypass grafting within 6 months prior to study treatment.
  • Patients with hypertension (defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg) or CTCAE Grade ≥2 hypotension.
  • Patients with uncontrolled or symptomatic hypercalcaemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium > ULN).
  • Patients with known previous malignancies other than NSCLC, except for those who have received radical therapy, have no evidence of disease recurrence within 5 years, and are assessed by the investigator to be at low risk of recurrence.

Trial locations and contacts

64 sites in 1 country.

64 sites in 1 country

China64 sites

  • Anyang Tumour Hospital

    Anyang

  • Beijing Chest Hospital, Capital Medical University

    Beijing

  • Bejing Chao-Yang Hospital, Capital Medical University

    Beijing

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu

  • Binzhou Medical University Hospital

    Binzhou

  • The Third Xiangya Hospital of Central South University

    Changsha

  • Xiangya Hospital of Central South University

    Changsha

  • Army characteristic Hospital Center( Daping Hospital of the Third Military Medical University)

    Chongqing

  • Chongqing University Cancer Hospital

    Chongqing

  • Chongqing University Three Gorges Hospital

    Chongqing

  • The People's Hospital of Dongguan

    Dongguan

  • The first people's hospital of Foshan

    Foshan

  • First Affiliated Hospital of Gannan Meidcal University

    Ganzhou

  • Ganzhou People's Hospital

    Ganzhou

  • Guangdong Provincial People's Hospital

    Guangzhou

  • Guizhou Provincial People's Hospital

    Guiyang

  • Harbin Medical university cancer hospital

    Ha’erbin

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou

  • Anhui provincial cancer hospital

    Hefei

  • The First Affiliated Hospital of Anhui Medical University

    Hefei

  • Jiamusi Tumour Hospital

    Jiamusi

  • Jiangmen Central hospital

    Jiangmen

  • Jinan Central Hospital

    Jinan

  • Affiliated Hospital of Jining Medical University

    Jining

  • Linyi People's Hospital

    Linyi

  • Lishui Central Hospital

    Lishui

  • Liuzhou Central Hospital

    Liuzhou

  • Longyan First Hospital

    Longyan

  • Jiangxi Cancer Hospital

    Nanchang

  • The First Affiliated Hospital Of Nanchang University

    Nanchang

  • Nanchong Central Hospital

    Nanchong

  • Jiangsu Province Hospital

    Nanjing

  • Guangxi Medical University Cancer Hospital

    Nanning

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning

  • Nantong Tumor Hospital

    Nantong

  • Nanyang Cenreal Hospital

    Nanyang

  • The Second People's Hospital of Neijiang

    Neijiang

  • Qingdao Central Hospital

    Qingdao

  • The First People's Hospital Of Qujing

    Qujing

  • Yuebei People's Hospital

    Shaoguan

  • China Shenyang the Tenth People's Hospital(China Shenyang Chest Hospital)

    Shenyang

  • The Fourth Hospital Of Hebei Medical University

    Shijia Zhuang

  • Suining Central Hospital

    Suining

  • First Hospital of Shanxi Medical University

    Taiyuan

  • Taizhou Hospital of Zhejiang Province

    Taizhou

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • The Second Affiliated Hospital Of Xi'an Jiaotong University

    Xi'an

  • Xi'an Chest Hospital

    Xi'an

  • Fujian Provincial Cancer Hospital

    Xiamen

  • The First Affiliated Hospital Of Xiamen University

    Xiamen

  • The Second Affiliated Hospital of Xiamen Medical College

    Xiamen

  • Xiangyang Central Hospital

    Xiangyang

  • Northern Jiangsu People's Hospital

    Yangzhou

  • The Second People's Hospital Of Yibin

    Yibin

  • Yichang Central People's Hospital

    Yichang

  • Shanxi Yuncheng Central hospital

    Yuncheng

  • The First Affiliated Hospital Of Henan University Of Science & Technology

    Zhengzhou

  • The First Affiliated Hospital Of Zhengzhou University

    Zhengzhou

  • Zhoukou Central hospital

    Zhoukou

  • Zhujiang hospital of Southern Medical University

    Zhujiang

  • Zibo Municipal Hospital

    Zibo

  • The first people's hospital of Zunyi

    Zunyi

Other trials in China

About this study

Official title: A Phase II/III, Randomized, Multicenter, Open-Label 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

This is a Phase II/III, randomized, open-label, active-controlled, multicenter study to compare intravenous uliledlimab combined with toripalimab, toripalimab monotherapy, and pembrolizumab monotherapy in patients with previously untreated locally advanced unresectable or metastatic PD-L1-positive (tumor proportion score [TPS] ≥ 1%) and CD73-positive (TC/IC > 30%; TC/IC defined as the higher of either the proportion of CD73-positive tumor cells or the proportion of CD73-positive immune cells at any intensity [IHC1+ or above]) NSCLC who are not suitable for targeted therapies such as EGFR, ALK, etc.

The number of enrolled subjects with PD-L1 TPS ≥ 50% will be limited to approximately 60% of the total sample size to reflect the natural prevalence of advanced NSCLC.

Read more

Patients who have received adjuvant or neoadjuvant therapy other than immune checkpoint inhibitor treatments are allowed to participate in this study, provided that such treatments have been completed at least 12 months prior to the occurrence of recurrence or metastasis.

During the screening period, tumor samples will be collected in advance and tested by the central laboratory for PD-L1 expression levels using the PD-L1 IHC 22C3 pharmDx assay and CD73 expression levels using the CD73 antibody assay (immunohistochemistry). Previous PD-L1 testing results obtained using the PD-L1 IHC 22C3 pharmDx assay will be accepted. Patients with PD-L1 positive expression (TPS ≥ 1%) and high CD73 expression (TC/IC > 30%) will meet the inclusion criteria.

Patients who do not meet the eligibility criteria as judged by the investigator may be re-screened once.

Patients with non-squamous NSCLC will be required to confirm the absence of EGFR-sensitive mutations or ALK fusion; patients with unknown EGFR and ALK expression status will be required to undergo testing and provide clinical laboratory test results prior to study enrollment, and may be enrolled after relevant driver gene mutations are ruled out. Meanwhile, patients with other definite actionable driver gene alterations (such as: ROS1 fusions, RET fusions, NTRK1/2/3 fusions, BRAF V600E mutations, MET14 exon skipping mutations, etc.) will be excluded from this study. Controversial cases with actionable gene mutations will be submitted to the study expert panel for joint decision.

This study includes Phase II and Phase III stages. Approximately 150 subjects will be enrolled in the Phase II stage. Based on the evaluation of the efficacy, safety, PK, and PD results of the Phase II study, a decision will be made on whether to proceed to the Phase III study. Approximately 300 subjects will be enrolled in the Phase III stage.

Being tested
Uliledlimab, Toripalimab, Pembrolizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UliledlimabDrug

    30 mg/kg, administered on Days 1 and 8 of Cycle 1 (C1D1 and C1D8), then once every 3 weeks (Q3W) starting from C2D1,

  • ToripalimabDrug

    240 mg on Day 1, once every 3 weeks (Q3W)

  • PembrolizumabDrug

    200 mg on Day 1, once every 3 weeks (Q3W)

Study groups in NCT06984588
Study groupRoleWhat they receive
Group AExperimentalNot described
Receives: Drug: Uliledlimab; Drug: Toripalimab
Group BActive comparatorNot described
Receives: Drug: Pembrolizumab
Group CSham comparatorNot described
Receives: Drug: Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    Measured: 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 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2025
  2. Study start28 Mar 2024
  3. Primary completion5 Aug 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06984588
Sponsor's protocol ID
TJ004309LUC301
Status last verified
Jan 2026
First submitted
22 Apr 2025
Last updated
30 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Uliledlimab, Toripalimab and Pembrolizumab in people with Non Small Cell Lung Cancer, run by TJ Biopharma Co., Ltd. at 64 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: 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 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06984588.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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