New drug cocktail aims to outperform standard lung cancer therapy

NCT ID NCT06984588

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

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

Summary

This study tests whether a new drug combination (uliledlimab plus toripalimab) works better than the standard immunotherapy pembrolizumab for people with advanced non-small cell lung cancer that hasn't been treated yet. The trial includes 450 participants whose tumors have specific markers (PD-L1 and CD73). The goal is to see if the new combo can delay cancer growth better than current options.

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 toripalimab
What this could lead to: If successful, this combination could offer a new first-line treatment option for people with a specific type of advanced lung cancer, potentially improving how long they live without their cancer growing.
What could go wrong: This is an early-to-mid stage trial, so the new combination may not work better than existing treatments. It also only includes patients with certain genetic markers, so results may not apply to everyone with lung cancer.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 450 people

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

Started

Mar 2024

Expected to finish

Sep 2028

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 (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). 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. 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. 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. 3. 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). 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 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. 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 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.

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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

Affiliated Hospital of Jining Medical University

Jining, China
Anhui provincial cancer hospital

Hefei, China
Anyang Tumour Hospital

Anyang, China
Army characteristic Hospital Center( Daping Hospital of the Third Military Medical University)

Chongqing, China
Beijing Chest Hospital, Capital Medical University

Beijing, China
Bejing Chao-Yang Hospital, Capital Medical University

Beijing, China
Binzhou Medical University Hospital

Binzhou, China
China Shenyang the Tenth People's Hospital(China Shenyang Chest Hospital)

Shenyang, China
Chongqing University Cancer Hospital

Chongqing, China
Chongqing University Three Gorges Hospital

Chongqing, China
First Affiliated Hospital of Gannan Meidcal University

Ganzhou, China
First Hospital of Shanxi Medical University

Taiyuan, China
Fujian Provincial Cancer Hospital

Xiamen, China
Ganzhou People's Hospital

Ganzhou, China
Guangdong Provincial People's Hospital

Guangzhou, China
Guangxi Medical University Cancer Hospital

Nanning, China
Guizhou Provincial People's Hospital

Guiyang, China
Harbin Medical university cancer hospital

Ha’erbin, China
Jiamusi Tumour Hospital

Jiamusi, China
Jiangmen Central hospital

Jiangmen, China
Jiangsu Province Hospital

Nanjing, China
Jiangxi Cancer Hospital

Nanchang, China
Jinan Central Hospital

Jinan, China
Linyi People's Hospital

Linyi, China
Lishui Central Hospital

Lishui, China
Liuzhou Central Hospital

Liuzhou, China
Longyan First Hospital

Longyan, China
Nanchong Central Hospital

Nanchong, China
Nantong Tumor Hospital

Nantong, China
Nanyang Cenreal Hospital

Nanyang, China
Northern Jiangsu People's Hospital

Yangzhou, China
Qingdao Central Hospital

Qingdao, China
Shanxi Yuncheng Central hospital

Yuncheng, China
Suining Central Hospital

Suining, China
Taizhou Hospital of Zhejiang Province

Taizhou, China
The First Affiliated Hospital Of Henan University Of Science & Technology

Zhengzhou, China
The First Affiliated Hospital Of Nanchang University

Nanchang, China
The First Affiliated Hospital Of Xiamen University

Xiamen, China
The First Affiliated Hospital Of Zhengzhou University

Zhengzhou, China
The First Affiliated Hospital of Anhui Medical University

Hefei, China
The First Affiliated Hospital of Bengbu Medical University

Bengbu, China
The First Affiliated Hospital of Guangxi Medical University

Nanning, China
The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China
The First People's Hospital Of Qujing

Qujing, China
The Fourth Hospital Of Hebei Medical University

Shijia Zhuang, China
The People's Hospital of Dongguan

Dongguan, China
The Second Affiliated Hospital Of Xi'an Jiaotong University

Xi'an, China
The Second Affiliated Hospital of Hainan Medical University

Haikou, China
The Second Affiliated Hospital of Xiamen Medical College

Xiamen, China
The Second People's Hospital Of Yibin

Yibin, China
The Second People's Hospital of Neijiang

Neijiang, China
The Third Xiangya Hospital of Central South University

Changsha, China
The first people's hospital of Foshan

Foshan, China
The first people's hospital of Zunyi

Zunyi, China
Tianjin Medical University Cancer Institute & Hospital

Tianjin, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, China
Xi'an Chest Hospital

Xi'an, China
Xiangya Hospital of Central South University

Changsha, China
Xiangyang Central Hospital

Xiangyang, China
Yichang Central People's Hospital

Yichang, China
Yuebei People's Hospital

Shaoguan, China
Zhoukou Central hospital

Zhoukou, China
Zhujiang hospital of Southern Medical University

Zhujiang, China
Zibo Municipal Hospital

Zibo, China

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