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Non Small Cell Lung CancerPhase 2NCT07005336

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

A Phase 2 study testing Uliledlimab, Sintilimab and Pemetrexed in people with Non Small Cell Lung Cancer, run by TJ Biopharma Co., Ltd. at 28 sites in China.

Active, not recruiting

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

Official record
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Trial summary

This is a Phase II, randomized, open-label, active-controlled, multicenter study to compare intravenous uliledlimab combined with sintilimab and chemotherapy versus sintilimab combined with chemotherapy in patients with previously untreated locally advanced unresectable or metastatic NSCLC who are not suitable for… 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, Sintilimab and Pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
28 sitesChina
Study dates
9 Jan 2025to 9 Jan 2029
Phase
Phase 2
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 who are not suitable for radical surgery and/or radiotherapy.
  • 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.
  • atients with known PD-L1 and CD73 expression status in tumor tissue: 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 or CD73 inhibitors.
  • Patients who are receiving or have completed systemic immune agonist therapy (including but not limited to: interferon, interleukin-2, and thymosin) 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 25; 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 history of or current hearing injury or Grade ≥2 peripheral neuropathy as defined by CTCAE v5.0 criteria (only for patients treated with cisplatin).

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

China28 sites

  • Beijing Chest Hospital

    Beijing

  • Binzhou Medical University Hospital

    Binzhou

  • Sichuan Cancer Hospital

    Chengdu

  • Chongqing University Three Gorges Hospital

    Chongqing

  • Harbin Medical University Cancer Hospital

    Ha’erbin

  • Anhui Provincial Cancer Hospital

    Hefei

  • The First Affiliated Hospital of Anhui Medical University

    Hefei

  • Jiangmen Central Hospital

    Jiangmen

  • Yunan Cancer Hospital

    Kunming

  • Linyi People's Hospital

    Linyi

  • Lishui Central Hospital

    Lishui

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • Guangxi Medical University Cancer Hospital

    Nanning

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning

  • The Second People's Hospital of Neijiang

    Neijiang

  • Shanghai Chest Hospital

    Shanghai

  • First Hospital of Shanxi Medical University

    Taiyuan

  • Shanxi Provincial Cancer Hospital

    Taiyuan

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou

  • Hubei Cancer Hospital

    Wuhan

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • Xiangyang Central Hospital

    Xiangyang

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang

  • The Second People's Hospital of Yibin

    Yibin

  • General Hospital of Ningxia Medical University

    Yinchuan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

  • Zhoukou Central Hospital

    Zhoukou

Other trials in China

About this study

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

This is a Phase II, randomized, open-label, active-controlled, multicenter study to compare intravenous uliledlimab combined with sintilimab and chemotherapy versus sintilimab combined with chemotherapy in patients with previously untreated locally advanced unresectable or metastatic NSCLC who are not suitable for targeted therapies such as EGFR or ALK.

Eligible subjects will be randomly assigned in a 1:1 ratio to receive either uliledlimab combined with sintilimab and chemotherapy or sintilimab combined with chemotherapy. Enrolled subjects will first enter a safety run-in period. When at least 12 subjects have been randomly assigned to Group A and have received ≥ 1 dose of study drug (with a total of approximately 24 subjects), enrollment will be suspended for safety evaluation. The safety evaluation period will last 3 weeks, during which safety, tolerability, and PK data of uliledlimab combined with sintilimab and chemotherapy will be collected and evaluated by the Safety Review Committee (SRC). The SRC will decide through discussion whether to proceed to the next stage of randomized enrollment, whether additional subjects need to be enrolled for safety evaluation, or whether the study treatment should be terminated due to high safety risks. After the SRC reaches a unanimous resolution, enrollment will continue until a total of approximately 150 subjects are enrolled. All 150 subjects will be included in the final efficacy analysis. If 3 or more subjects experience Grade ≥ 3 treatment-related AEs that are unrelieved and lead to discontinuation of all study drugs during the safety run-in period, enrollment in the next stage will be terminated.

Being tested
Uliledlimab, Sintilimab, Pemetrexed, Gemcitabine, Cisplatin Or Carboplatin
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,at most 35 cycles

  • SintilimabDrug

    Intravenous infusion at a recommended dose of 200 mg once every 3 weeks，at most 35 cycles

  • PemetrexedDrug

    Intravenously at a recommended dose of 500 mg/m2 body surface area (BSA) ,once every 3 weeks until the disease progresses.

  • GemcitabineDrug

    1000 mg/m2, administered on Days 1 and 8 ,once every 3 weeks (Q3W) for 4 cycles

  • Cisplatin Or CarboplatinDrug

    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

Study groups in NCT07005336
Study groupRoleWhat they receive
Group AExperimentalNon-squamous Squamous
Receives: Drug: Uliledlimab; Drug: Sintilimab; Drug: Pemetrexed; Drug: Gemcitabine; Drug: Cisplatin Or Carboplatin
Group BExperimentalNon-squamous Squamous
Receives: Drug: Sintilimab; Drug: Pemetrexed; Drug: Gemcitabine; Drug: Cisplatin Or Carboplatin

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 6months.

Timeline

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

  1. First posted5 Jun 2025
  2. Study start9 Jan 2025
  3. Primary completion30 Aug 2026 (estimated)
  4. Study completion9 Jan 2029 (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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07005336
Sponsor's protocol ID
TJ004309LUC201
Status last verified
Jan 2026
First submitted
21 May 2025
Last updated
30 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Uliledlimab, Sintilimab and Pemetrexed in people with Non Small Cell Lung Cancer, run by TJ Biopharma Co., Ltd. at 28 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 28 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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 6months.). 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 NCT07005336.

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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