Evaluating SHR-1826 with other cancer therapies for lung cancer

A Multicenter, Open Phase IB/II Clinical Study of Safety, Tolerability, and Efficacy of SHR-1826 in Combination With Other Anti-cancer Treatment in Patients With Non-small Cell Lung Cancer

This study is testing if a new drug called SHR-1826, when combined with other cancer treatments, can help people with non-small cell lung cancer feel better and respond well to therapy.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06754930 on ClinicalTrials.gov

What this trial studies

This open-label, multi-center Phase IB/II study aims to assess the safety, tolerability, and efficacy of SHR-1826 in combination with other antitumor therapies for patients with non-small cell lung cancer (NSCLC). Participants will receive multiple doses of SHR-1826 alongside other treatments, and the study will monitor their responses and any side effects. The trial includes both newly diagnosed patients and those with advanced disease, focusing on measurable lesions as defined by RECIST criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a confirmed diagnosis of NSCLC and an ECOG score of 0-1.

Not a fit: Patients with central nervous system metastasis or those with uncontrolled tumor-related pain 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 NSCLC.

How similar studies have performed: Other studies have shown promise with similar combination therapies in treating NSCLC, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Voluntary participation and written informed consent.
2. 18-75 years older, no gender limitation.
3. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
4. With a life expectancy ≥ 3 months.
5. Pathologically diagnosed NSCLC.
6. Be able to provide fresh or archived tumour tissue.
7. At least one measurable lesion according to RECIST v1.1.
8. Adequate organ function.
9. Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.

Exclusion Criteria:

1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
2. Previous or co-existing malignancies.
3. Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded.
4. Uncontrollable tumor-related pain.
5. Have undergone major surgery other than diagnosis or biopsy within 28 days prior to the initial dosing; Minor traumatic surgery within 7 days prior to the first dosing.
6. Received other investigational drugs treatments 4 weeks prior to the initiation of the study treatment.
7. Unresolved CTCAE 5.0\>grade 2 toxicities from previous anticancer therapy.
8. With poorly controlled or severe cardiovascular disease.
9. Active hepatitis B and hepatitis C.
10. Patients with a history of immunodeficiency.
11. Severe infection 30 days before the first dose.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yijun Jia

Conditions Non-small Cell Lung Cancer