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NCT06754930RecruitingPhase 1/2

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

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

Source: ClinicalTrials.gov · Last updated 17 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
400 (estimated)
First submitted
24 Dec 2024
Start date
18 Feb 2025
Primary completion date
Dec 2027
Lead sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Diseases
Lung cancer
NCT number
NCT06754930

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 400
  • From 18 Feb 2025 to the primary completion date, Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous or co-existing malignancies.
  • Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded.
  • 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.
  • Severe infection 30 days before the first dose.

Other illness

  • With poorly controlled or severe cardiovascular disease.
  • Active hepatitis B and hepatitis C.
  • Patients with a history of immunodeficiency.

Other

  • Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
  • Uncontrollable tumor-related pain.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai Chest Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.