A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC

Recruiting now · Phase 1/Phase 2

Conditions studied: Non-small Cell Lung Cancer (NSCLC)

In brief

This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with NSCLC.

Key facts

Study ID

NCT06754930

Run by

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

People needed

400

Starts

2025-02-18

Expected to finish

2027-12-01

Last updated by the study team

2025-04-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
• Previous or co-existing malignancies.
• Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded.
• Uncontrollable tumor-related pain.
• 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.
• Received other investigational drugs treatments 4 weeks prior to the initiation of the study treatment.
• Unresolved CTCAE 5.0>grade 2 toxicities from previous anticancer therapy.
• With poorly controlled or severe cardiovascular disease.
• Active hepatitis B and hepatitis C.
• Patients with a history of immunodeficiency.
• Severe infection 30 days before the first dose.

Where it is running

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

Full record on ClinicalTrials.gov

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