A Phase II Clinical Study of SHR-1826 for Injection in Patients With NSCLC

Last updated: March 17, 2025
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Non-small Cell Lung Cancer

Treatment

SHR-1826;Adebrelimab;SHR-8068;Bevacizumab

Clinical Study ID

NCT06844474
SHR-1826-203
  • Ages 18-75
  • All Genders

Study Summary

This study is an open-label, multicenter Phase II clinical trial to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in patients with NSCLC.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects must voluntarily agree to participate in the trial and sign a writteninformed 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

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 screeningsuggestive 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 ofstudy drug;

  6. Subjects with uncontrolled tumor-related pain;

  7. Received >30 Gy of non-thoracic radical radiation therapy within 4 weeks prior tothe 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 NCICTCAE v5.0);

  10. History of immunodeficiency, including a positive HIV test;

  11. Per the investigator's judgment, there are any other circumstances that may increasethe risk of participating in the study, interfere with the study results, or makeparticipation in the study inappropriate.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: SHR-1826;Adebrelimab;SHR-8068;Bevacizumab
Phase: 2
Study Start date:
March 07, 2025
Estimated Completion Date:
February 29, 2028

Connect with a study center

  • Chinese People's Liberation Army (PLA) General Hospital

    Beijing, Beijing 100039
    China

    Active - Recruiting

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