SHR-1826;Adebrelimab;SHR-8068;Bevacizumab: Drug:
Drug: SHR-1826 Administration by intravenous infusion for a cycle of 3 weeks.
Drug: Adebrelimab Administration by intravenous infusion for a cycle of 3 weeks.
Drug: SHR-8068 Administration by intravenous infusion for a cycle of 6 weeks.
Drug: Bevacizumab Administration by intravenous infusion for a cycle of 3 weeks.
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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence and severity of adverse events (AEs) /serious adverse events(SAEs) — approximately 2 years
Overall response rate (ORR) — approximately to 2 years
Trial sites (1)
Facility
City
Region
Status
Chinese People's Liberation Army (PLA) General Hospital
Beijing
Beijing Municipality
Recruiting
More Suzhou Suncadia Biopharmaceuticals Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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