Comparing three treatments for advanced non-small cell lung cancer

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 study is testing three different treatments for people with advanced lung cancer to see which one works best for those who haven't had treatment before.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: TJ Biopharma Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation, uliledlimab, toripalimab, pembrolizumab
• Locations: 64 sites (Anyang and 63 other locations)
• Trial ID: NCT06984588 on ClinicalTrials.gov

What this trial studies

This clinical trial is a Phase II/III, randomized, open-label study designed to evaluate the effectiveness of uliledlimab combined with toripalimab, toripalimab alone, and pembrolizumab alone in patients with previously untreated locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC). The study focuses on patients with specific PD-L1 and CD73 expression levels who are not candidates for targeted therapies. Participants will be assessed for measurable lesions and must meet specific inclusion criteria related to their cancer stage and treatment history.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with untreated locally advanced or metastatic non-small cell lung cancer that is not suitable for surgery or radiotherapy.

Not a fit: Patients with squamous NSCLC or those who have received prior systemic therapy for their cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced non-small cell lung cancer.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, suggesting potential for success in this trial.

Eligibility criteria

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.

Where this trial is running

Anyang and 63 other locations

• Anyang Tumour Hospital — Anyang, China (Recruiting)
• Beijing Chest Hospital, Capital Medical University — Beijing, China (Recruiting)
• Bejing Chao-Yang Hospital, Capital Medical University — Beijing, China (Recruiting)
• The First Affiliated Hospital of Bengbu Medical University — Bengbu, China (Recruiting)
• Binzhou Medical University Hospital — Binzhou, China (Recruiting)
• The Third Xiangya Hospital of Central South University — Changsha, China (Recruiting)
• Xiangya Hospital of Central South University — Changsha, China (Recruiting)
• Army characteristic Hospital Center( Daping Hospital of the Third Military Medical University) — Chongqing, China (Recruiting)
• Chongqing University Cancer Hospital — Chongqing, China (Recruiting)
• Chongqing University Three Gorges Hospital — Chongqing, China (Recruiting)
• The People's Hospital of Dongguan — Dongguan, China (Recruiting)
• The first people's hospital of Foshan — Foshan, China (Recruiting)
• First Affiliated Hospital of Gannan Meidcal University — Ganzhou, China (Recruiting)
• Ganzhou People's Hospital — Ganzhou, China (Recruiting)
• Guangdong Provincial People's Hospital — Guangzhou, China (Recruiting)
• Guizhou Provincial People's Hospital — Guiyang, China (Recruiting)
• Harbin Medical university cancer hospital — Ha'erbin, China (Recruiting)
• The Second Affiliated Hospital of Hainan Medical University — Haikou, China (Recruiting)
• Anhui provincial cancer hospital — Hefei, China (Recruiting)
• The First Affiliated Hospital of Anhui Medical University — Hefei, China (Recruiting)
• Jiamusi Tumour Hospital — Jiamusi, China (Recruiting)
• Jiangmen Central hospital — Jiangmen, China (Recruiting)
• Jinan Central Hospital — Jinan, China (Recruiting)
• Affiliated Hospital of Jining Medical University — Jining, China (Recruiting)
• Linyi People's Hospital — Linyi, China (Recruiting)
• Lishui Central Hospital — Lishui, China (Recruiting)
• Liuzhou Central Hospital — Liuzhou, China (Recruiting)
• Longyan First Hospital — Longyan, China (Recruiting)
• Jiangxi Cancer Hospital — Nanchang, China (Recruiting)
• The First Affiliated Hospital Of Nanchang University — Nanchang, China (Recruiting)
• Nanchong Central Hospital — Nanchong, China (Recruiting)
• Jiangsu Province Hospital — Nanjing, China (Recruiting)
• Guangxi Medical University Cancer Hospital — Nanning, China (Recruiting)
• The First Affiliated Hospital of Guangxi Medical University — Nanning, China (Recruiting)
• Nantong Tumor Hospital — Nantong, China (Recruiting)
• Nanyang Cenreal Hospital — Nanyang, China (Recruiting)
• The Second People's Hospital of Neijiang — Neijiang, China (Recruiting)
• Qingdao Central Hospital — Qingdao, China (Recruiting)
• The First People's Hospital Of Qujing — Qujing, China (Recruiting)
• Yuebei People's Hospital — Shaoguan, China (Recruiting)
• China Shenyang the Tenth People's Hospital(China Shenyang Chest Hospital) — Shenyang, China (Recruiting)
• The Fourth Hospital Of Hebei Medical University — Shijia Zhuang, China (Recruiting)
• Suining Central Hospital — Suining, China (Recruiting)
• First Hospital of Shanxi Medical University — Taiyuan, China (Recruiting)
• Taizhou Hospital of Zhejiang Province — Taizhou, China (Recruiting)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, China (Recruiting)
• Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology — Wuhan, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China (Recruiting)
• The Second Affiliated Hospital Of Xi'an Jiaotong University — Xi'an, China (Recruiting)
• Xi'an Chest Hospital — Xi'an, China (Recruiting)

Study contacts

• Study coordinator: Mei Huang

Conditions Non Small Cell Lung Cancer