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New drug cocktail aims to stall lung cancer

NCT ID NCT07005336

Disease control Sponsor: TJ Biopharma Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding a new drug called uliledlimab to standard immunotherapy and chemotherapy can help people with advanced non-small cell lung cancer live longer without their disease getting worse. About 150 adults who have not had prior treatment for their advanced cancer will be randomly assigned to receive either the three-drug combo or the standard two-drug combo. The trial is currently active but not recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
uliledlimab combined with sintilimab and chemotherapy
What this could lead to
If successful, this could lead to a new treatment option that slows the progression of advanced lung cancer.
What could go wrong
This is an early Phase 2 trial with only 150 participants, so results may not apply to everyone. There is also a risk of serious side effects from the combination therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 locally advanced or metastatic diseases. 4. 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. 5. Patients with non-squamous NSCLC who are confirmed to have no EGFR-sensitive mutations or ALK fusions. 6. 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. 7. Patients with a life expectancy of at least 3 months. 8. Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 9. Patients with adequate organ function. 10. Patients with negative HIV testing at screening. 11. 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. 12. Patients with negative hepatitis C virus (HCV) antibody at screening, or positive HCV antibody and negative HCV RNA at screening. 13. 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. 14. 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. 15. Patients who voluntarily agree to participate in the study and sign a written ICF. Exclusion Criteria: 1. Patients who are currently pregnant, breastfeeding, or planning to conceive or give birth within the expected duration of this study. 2. Patients previously treated with immune checkpoint inhibitors or CD73 inhibitors. 3. 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). 4. Patients who have received oral or intravenous antibiotic therapy within 2 weeks prior to starting study treatment, except for prophylactic use. 5. Patients who have undergone major surgery within 4 weeks prior to starting study treatment, except for diagnostic surgery. 6. 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. 7. 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. 8. Patients who have received any anti-tumor therapeutic agents containing traditional Chinese medicine ingredients within 4 weeks prior to starting study treatment. 9. Patients who have previously received an allogeneic tissue/organ transplant. 10. Patients who are expected to require any other form of anti-tumor therapy during the course of the study. 11. 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. 12. 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. 13. Patients with hypertension (defined as systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg) or CTCAE Grade ≥2 hypotension. 14. Patients with uncontrolled or symptomatic hypercalcaemia (\> 1.5 mmol/L ionized calcium or calcium \> 12 mg/dL or corrected serum calcium \> ULN). 15. 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).

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

  • Anhui Provincial Cancer Hospital

    Hefei, China

  • Beijing Chest Hospital

    Beijing, China

  • Binzhou Medical University Hospital

    Binzhou, China

  • Chongqing University Three Gorges Hospital

    Chongqing, China

  • First Hospital of Shanxi Medical University

    Taiyuan, China

  • General Hospital of Ningxia Medical University

    Yinchuan, China

  • Guangxi Medical University Cancer Hospital

    Nanning, China

  • Harbin Medical University Cancer Hospital

    Ha’erbin, China

  • Hubei Cancer Hospital

    Wuhan, China

  • Jiangmen Central Hospital

    Jiangmen, China

  • Linyi People's Hospital

    Linyi, China

  • Lishui Central Hospital

    Lishui, China

  • Shanghai Chest Hospital

    Shanghai, China

  • Shanxi Provincial Cancer Hospital

    Taiyuan, China

  • Sichuan Cancer Hospital

    Chengdu, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, China

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, China

  • The Second People's Hospital of Neijiang

    Neijiang, China

  • The Second People's Hospital of Yibin

    Yibin, China

  • Xiangyang Central Hospital

    Xiangyang, China

  • Yunan Cancer Hospital

    Kunming, China

  • Zhoukou Central Hospital

    Zhoukou, China

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