NCT03083041

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2017

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

March 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2022

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

March 3, 2026

Completed
Last Updated

March 3, 2026

Status Verified

June 1, 2022

Enrollment Period

5.1 years

First QC Date

March 2, 2017

Results QC Date

May 5, 2023

Last Update Submit

March 2, 2026

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

SHR-1210ApatinibNSCLC

Outcome Measures

Primary Outcomes (2)

  • Incidence and Grade of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Number of participants with Adverse Events and Serious Adverse Events

    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.

    from first administration to progressive disease or initiation of new anti-cancer therapy, 61 months

Study Arms (3)

SHR-1210，200mg,q2w plus apatinib 250mg/d

EXPERIMENTAL

SHR-1210 200mg, IV, Q2W and Apatinib 250mg, PO, QD

Biological: SHR-1210Drug: Apatinib

SHR-1210，200mg,q2w plus apatinib 500mg/d

EXPERIMENTAL

SHR-1210 200mg, IV, Q2W and Apatinib 500mg, PO, QD

Biological: SHR-1210Drug: Apatinib

SHR-1210，200mg,q2w plus apatinib 375mg/d

EXPERIMENTAL

SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD

Biological: SHR-1210Drug: Apatinib

Interventions

SHR-1210BIOLOGICAL

SHR-1210 will be administered as a 30-minute IV infusion Q2W at a dose of 200mg

SHR-1210，200mg,q2w plus apatinib 250mg/dSHR-1210，200mg,q2w plus apatinib 375mg/dSHR-1210，200mg,q2w plus apatinib 500mg/d
ApatinibDRUG

Apatinib tablet will be administered orally,once daily until progression

Also known as: Apatinib Mesylate
SHR-1210，200mg,q2w plus apatinib 250mg/dSHR-1210，200mg,q2w plus apatinib 375mg/dSHR-1210，200mg,q2w plus apatinib 500mg/d

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (1)

  • 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.

    PMID: 35832447DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

camrelizumabapatinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Sihao Sun
Organization
Jiangsu HengRui Pharmaceuticals Co., Ltd.
sihao.sun@hengrui.com
+86 18205136109

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2017

First Posted

March 17, 2017

Study Start

March 13, 2017

Primary Completion

April 22, 2022

Study Completion

April 22, 2022

Last Updated

March 3, 2026

Results First Posted

March 3, 2026

Record last verified: 2022-06

Locations

CN(1)