NSCLC
Conditions
Brief 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.
Interventions
DRUGSHR-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.
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (AEs) /serious adverse events(SAEs) | approximately 2 years |
| Overall response rate (ORR) | approximately to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DoR) | approximately to 2 years |
| Disease control rate (DCR) | approximately to 2 years |
| Progression-free survival (PFS) | approximately to 2 years |
| Overall survival (OS) | approximately to 5 years after last subject enrolled |
Countries
China
Contacts
CONTACTLi Song
Outcome results
None listed