Phase 2
Completed N=59
SHR-1210 Combined With Apatinib in Treatment of ED-SCLC After Failure of First Line Standard Therapy
Source: ClinicalTrials.gov NCT03417895 ↗Enrolled (actual)
59
Serious AEs
55.9%
Results posted
Aug 2024
Primary outcomePrimary: Adverse Event — 47; 6; 5 participants
Summary
This is a multi-center, open-label, phase II study of intravenous (IV) SHR-1210 at 200mg,q2w in combination with Apatinib at one dose (375mg). Comparison of 3 different dose schedules in subjects with extensive-stage disease small cell lung cancer. SHR-1210 is a humanized monoclonal antibody against Programmed death 1(PD-1). Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) tyrosine kinase inhibitor (TKI).
The study is composed of two parts. Part 1 of the study will determine the safety and tolerability of SHR-1210 in combination with Apatinib in first 6 subjects of each arm. The second phase of treatment was carried out by selecting one group of administration mode and the tolerated dose of Apatinib. Part 2 of the study will determine the safety and efficacy of SHR-1210 in combination with Apatinib in 39 subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Event |
47; 6; 5 | — |
| PRIMARY ORR |
34.0; 33.3; 33.3 | — |
| SECONDARY OS Rate |
63.8; 66.7; 44.4 | — |
| SECONDARY PFS |
3.6; 3.6; 1.2 | — |
| SECONDARY TTR |
1.0; 1.8; 4.6 | — |
| SECONDARY DoR |
6.2; 4.2; 8.0 | — |
| SECONDARY DCR |
68.1; 100.0; 50.0 | — |
| SECONDARY OS |
8.8; 11.2; 5.4 | — |
Eligibility Criteria
Inclusion Criteria
- Signed inform consent form.
- Age >= 18 years and = 8 weeks.
- Adequate hematologic and end organ function.
Exclusion Criteria
- Histologically or cytologically confirmed mixed non-small cell and small cell carcinoma.
- Prior exposure to therapeutic anticancer vaccines; prior exposure to any T cell co-stimulatory therapy or immune checkpoint inhibitors, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-PD-L2 antibodies.
- Prior exposure to anti-VEGF or anti-VEGFR therapy.
- Active brain metastasis or meningeal metastasis.
- Clinically significant third space effusion (e.g., uncontrolled pericardial effusion, ascites or pleural effusion by extraction or other treatment).
- Known hypersensitivity to study drug or any of its excipients; known hypersensitivity to any antibody.
- Treatment with any other investigational agent or participation in another clinical trial within 4 weeks prior to screening.
- Other conditions that the investigator thinks unsuitable in this study.
Data sourced from ClinicalTrials.gov (NCT03417895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.