Evaluating SHR-1826 for patients with non-small cell lung cancer

A Phase II, Multicenter, Open-Label Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-1826 for Injection in Patients With NSCLC

This study is testing a new injectable treatment called SHR-1826 to see if it can help people with non-small cell lung cancer feel better compared to current options.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06844474 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial is designed to assess the safety, tolerability, and efficacy of SHR-1826, an injectable treatment, in patients diagnosed with non-small cell lung cancer (NSCLC). The study is open-label and multicenter, meaning it will involve multiple locations and participants will know the treatment they are receiving. Eligible patients must have measurable tumor lesions and meet specific health criteria to ensure their safety during the trial. The trial aims to gather data on how well SHR-1826 works compared to existing treatments.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with histologically confirmed locally advanced or metastatic NSCLC and a good performance status.

Not a fit: Patients with active central nervous system metastases or severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with NSCLC.

How similar studies have performed: While this approach is being evaluated in this trial, similar studies have shown promise in targeting NSCLC with novel therapies.

Eligibility criteria

Inclusion Criteria:

1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
2. ECOG performance score of 0-1.
3. Life expectancy ≥ 3 months.
4. Have at least one measurable tumor lesion per RECIST v1.1.
5. Subjects with histologically confirmed locally advanced or metastatic NSCLC.
6. Good level of organ function.
7. Provide archived or fresh tumor tissue for vendor test.

Exclusion Criteria:

1. Subjects with active central nervous system metastases or meningeal metastases;
2. History of serious cardiovascular and cerebrovascular diseases;
3. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis;
4. Severe infection within 4 weeks prior to the first dose;
5. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
6. Subjects with uncontrolled tumor-related pain;
7. Received \>30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
8. Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
9. Unresolved toxicities from previous anti-tumor therapy to ≤ Grade 1 (based on NCI CTCAE v5.0);
10. History of immunodeficiency, including a positive HIV test;
11. Per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.

Where this trial is running

Beijing, Beijing Municipality

• Chinese People's Liberation Army (PLA) General Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Li Song

Conditions NSCLC