Phase 2
Completed N=210
A Study of SHR-1210 in Combination With Apatinib in Advanced Non-Small Cell Lung Cancer(NSCLC)
Carcinoma, Non-Small-Cell Lung
Source: ClinicalTrials.gov NCT03083041 ↗
Enrolled (actual)
210
Serious AEs
56.7%
Results posted
Mar 2026
Primary outcomePrimary: Incidence and Grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) — 130; 43; 25; 12 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 two dose levels in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).
The study is composed of two parts. Part 1 of the study will determine the safety, tolerability and pharmacokinetics of SHR-1210 in combination with Apatinib.
Part 2 includes a randomized comparison of Apatinib 250mg/d or 500mg/d plus SHR-1210.
Subject's tumors will be screened at baseline for EGFR mutations, EML4-ALK translocation, and PD-L1 expression.But positive tumor PD-L1 expression will not be required for enrollment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence and Grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) |
130; 43; 25; 12; 82; 21 | — |
| PRIMARY Objective Response Rate (ORR)： |
28.5; 18.6; 40.0; 16.7 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects >/= 18 years and /= 140 mm Hg and/or diastolic pressure >/= 90 mm Hg), and Grade III-IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF /= CTCAE 2 pneumorrhagia or >/= CTCAE 3 hemorrhage in other organs within 4 weeks.
- Bone fracture or wounds that was not cured.
- Arterial thrombus or phlebothrombosis within 6 months and taking anticoagulant agents.
- Mental diseases and psychotropic substances abuse.
- Previous treatment with an trial agent within 4 weeks
- Proteinuria ≥ (++) or 24 hours total urine protein > 1.0 g.
- Other coexisting malignant disease (except basal-cell carcinoma and carcinoma in situ of uterine cervix).
Data sourced from ClinicalTrials.gov (NCT03083041). 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.