AzTrials
AzTrials

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
Search all trials

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
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
Are there results?
Yes, posted in the registrySummary in the doctors' view

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.
Show all 9Show fewer
  • 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.
Show all 11Show fewer
  • 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

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.

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.

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 groupRoleWhat they receive
SHR-1210，200mg,q2w plus apatinib 250mg/dExperimentalSHR-1210 200mg, IV, Q2W and Apatinib 250mg, PO, QD
Receives: Biological: SHR-1210; Drug: Apatinib
SHR-1210，200mg,q2w plus apatinib 500mg/dExperimentalSHR-1210 200mg, IV, Q2W and Apatinib 500mg, PO, QD
Receives: Biological: SHR-1210; Drug: Apatinib
SHR-1210，200mg,q2w plus apatinib 375mg/dExperimentalSHR-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.

  1. 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

  2. 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.

  1. First posted17 Mar 2017
  2. Study start13 Mar 2017
  3. Primary completion22 Apr 2022
  4. Study completion22 Apr 2022

Resources

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
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and Grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: from signing the informed consent form to safety follow-up, 61 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03083041, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in