Carcinoma, Non-Small-Cell LungPhase 2NCT03083041

A Study of SHR-1210 in Combination With Apatinib in Advanced Non-Small Cell Lung Cancer(NSCLC)

A Phase 2 study testing SHR-1210 and Apatinib in people with Carcinoma, Non-Small-Cell Lung, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Carcinoma, Non-Small-Cell Lung
What is being tested?: SHR-1210 and Apatinib
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 210 participants
Where: 1 siteChina
Study dates: 13 Mar 2017to 22 Apr 2022
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects >/= 18 years and </=70 years of age at the time of Informed Consent.
Advanced relapsed or refractory predominantly NSCLC with at least one measurable lesion according to RECIST 1.1.
Failure of second line of chemotherapy(Part 1); Failure of First line of chemotherapy(Part 2)
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Patients must have recovered from any AEs of prior treatments before randomization.
Adequate bone marrow,liver and renal function as assessed by the following laboratory tests conducted within 1 week before randomization. HB ≥ 90g/L; ANC≥1.5×10E+9/L; PLT≥100×10E+9/L; ALT and AST < 1.5×ULN; TBIL ≤1×ULN; Cr ≤1.5×ULN or CL≥60 ml/min.

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Life expectancy of at least three months.
Male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 60 days for female subjects and 120 days for male subjects after the last dose of study drug.
Written informed consent and the willingness and ability to comply with all aspects of the protocol.

Who cannot join

Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female≥ 470 ms).
Severe or uncontrolled systemic disease such as clinically significant hypertension (systolic pressure >/= 140 mm Hg and/or diastolic pressure >/= 90 mm Hg), and Grade III-IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF<50%.
Factors to affect oral administration (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction).
Coagulation disfunction,hemorrhagic tendency or receiving anticoagulant therapy
>/= CTCAE 2 pneumorrhagia or >/= CTCAE 3 hemorrhage in other organs within 4 weeks.
Bone fracture or wounds that was not cured.

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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).

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433

Other trials in China

About this study

Official title: A Phase II Study of SHR-1210 in Combination With Apatinib in Advanced Non-Small Cell Lung

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.

Read the detailed description

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). A disease-control rate of 61.1% and a mPFS of 4.7 months were showed in Apatinib phase II study in patients with NSCLC.

Conditions: Carcinoma, Non-Small-Cell Lung
Being tested: SHR-1210, Apatinib
Keywords: SHR-1210, Apatinib, NSCLC
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SHR-1210Biological
SHR-1210 will be administered as a 30-minute IV infusion Q2W at a dose of 200mg
ApatinibDrug
Also called Apatinib Mesylate
Apatinib tablet will be administered orally,once daily until progression

Study groups in NCT03083041
Study group	Role	What they receive
SHR-1210，200mg,q2w plus apatinib 250mg/d	Experimental	SHR-1210 200mg, IV, Q2W and Apatinib 250mg, PO, QD Receives: Biological: SHR-1210; Drug: Apatinib
SHR-1210，200mg,q2w plus apatinib 500mg/d	Experimental	SHR-1210 200mg, IV, Q2W and Apatinib 500mg, PO, QD Receives: Biological: SHR-1210; Drug: Apatinib
SHR-1210，200mg,q2w plus apatinib 375mg/d	Experimental	SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD Receives: Biological: SHR-1210; Drug: Apatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence and Grade of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with Adverse Events and Serious Adverse Events
Measured: from signing the informed consent form to safety follow-up, 61 months
Objective Response Rate (ORR)：
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: from first administration to progressive disease or initiation of new anti-cancer therapy, 61 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 201722 Apr 2022

First posted17 Mar 2017
Study start13 Mar 2017
Primary completion22 Apr 2022
Study completion22 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 210 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03083041
Sponsor's protocol ID: SHR-1210-APTN-II-202-NSCLC
Status last verified: Jun 2022
First submitted: 2 Mar 2017
Last updated: 3 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Gao G, Ni J, Wang Y, Ren S, Liu Z, Chen G, Gu K, Zang A, Zhao J, Guo R, He J, Lin X, Pan Y, Ma Z, Wang Z, Fan M, Liu Y, Cang S, Yang X, Li W, Wang Q, Zhou C. Efficacy and safety of camrelizumab plus apatinib in previously treated patients with advanced non-small cell lung cancer harboring EGFR or ALK genetic aberration. Transl Lung Cancer Res. 2022 Jun;11(6):964-974. doi: 10.21037/tlcr-22-22.
PubMed 35832447

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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