Small-cell Lung CancerPhase 2PASSIONNCT03417895

SHR-1210 Combined With Apatinib in Treatment of ED-SCLC After Failure of First Line Standard Therapy

A Phase 2 study testing SHR-1210 and Apatinib in people with Small-cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites 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

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Small-cell Lung Cancer
What is being tested?: SHR-1210 and Apatinib
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 2 sitesChina
Study dates: 20 Apr 2018to 4 Aug 2021
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

Signed inform consent form.
Age >= 18 years and <= 70 years.
Histologically or cytologically confirmed small cell lung cancer.
ED-SCLC according to Veterans Administration Lung Study Group.
Radiographically progression following a platinum-based standard prior chemotherapy regimen.
Eastern Cooperative Oncology Group performance status of 0 or 1.

Show all 9Show fewer

Measurable disease as defined by RECIST v1.1.
Life expectancy >= 8 weeks.
Adequate hematologic and end organ function.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022

Other trials in China

About this study

Official title: Anti-PD-1 Antibody SHR-1210 Combined With Anti-angiogenesis Inhibitor Apatinib in Treatment of Extensive-stage Disease Small Cell Lung Cancer After Failure of First Line Standard Therapy

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.

Conditions: Small-cell Lung Cancer
Being tested: SHR-1210, Apatinib
Medical subject headings: Small Cell Lung Carcinoma

What participants receive

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

SHR-1210Drug
A humanized anti-PD-1 monoclonal antibody
ApatinibDrug
A tyrosine kinase inhibitor selectively targeting VEGFR-2

Study groups in NCT03417895
Study group	Role	What they receive
A (SHR-1210+Apatinib)	Experimental	SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD Receives: Drug: SHR-1210; Drug: Apatinib
B (SHR-1210+Apatinib)	Experimental	SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD (5 Days on, 2 Days off) Receives: Drug: SHR-1210; Drug: Apatinib
C (SHR-1210+Apatinib)	Experimental	SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD (7 Days on, 7 Days off) Receives: Drug: SHR-1210; Drug: Apatinib

What is being measured

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

Adverse Event
Evaluation of adverse event rate according to CTCAE v4.03
Measured: 24 months
ORR
Objective response rate according to RECIST v1.1 (Response was assessed with CT or MRI using RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to<10 mm; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Over all response：CR+PR)
Measured: 6 months

Secondary outcomes (6)

OS Rate
Overall survival rate
Measured: 6 months
PFS
Progression-free survival according to RECIST v1.1
Measured: Imaging assessment was performed on C1D28 and every 8 weeks after C1D28 until radiographic progressive disease (PD) was documented.
TTR
Time to response according to RECIST v1.1 (Response was assessed with CT or MRI using RECIST v1.1, Time to response (TTR): date of first dose to date of first documented CR or PR)
Measured: Imaging assessment was performed on C1D28 and every 8 weeks after C1D28 until radiographic progressive disease (PD) was documented.
DoR
Duration of response according to RECIST v1.1 (Response was assessed with CT or MRI using RECIST v1.1, Duration of response (DoR): DoR will only be performed in subjects who have a confirmed tumor response (CR or PR) after treatment
Measured: Imaging assessment was performed on C1D28 and every 8 weeks after C1D28 until radiographic progressive disease (PD) was documented.
DCR
Disease control rate according to RECIST v1.1 (Response was assessed with CT or MRI using RECIST v1.1; Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to<10 mm; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Disease control rate (DCR): CR+PR+SD
Measured: Imaging assessment was performed on C1D28 and every 8 weeks after C1D28 until radiographic progressive disease (PD) was documented.
OS
Overall survival
Measured: on average of 2 years

Timeline

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

20 Apr 20184 Aug 2021

First posted31 Jan 2018
Study start20 Apr 2018
Primary completion4 Aug 2021
Study completion4 Aug 2021

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 Small-cell Lung CancerStudies 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: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03417895
Sponsor's protocol ID: SHR-1210-II-206
Acronym: PASSION
Status last verified: Apr 2023
First submitted: 8 Jan 2018
Last updated: 7 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Fan Y, Zhao J, Wang Q, Huang D, Li X, Chen J, Fang Y, Duan J, Zhou C, Hu Y, Yang H, Hu Y, Zhou J, Lin X, Wang L, Wang Z, Xu Y, Zhang T, Shi W, Zou J, Wang J. Camrelizumab Plus Apatinib in Extensive-Stage SCLC (PASSION): A Multicenter, Two-Stage, Phase 2 Trial. J Thorac Oncol. 2021 Feb;16(2):299-309. doi: 10.1016/j.jtho.2020.10.002. Epub 2020 Nov 6.
PubMed 33166719

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?

See locations

Recruiting
Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy
Lung Neoplasm
Active, not recruitingPhase 2
1st Line Durvalumab in PS 2 NSCLC Patients
NSCLC Stage IV, NSCLC Stage IIIB
Active, not recruitingPhase 2
Multimodality Treatment in Stage III Non-small Cell Lung Cancer (NSCLC)
Non-small Cell Lung Cancer, NSCLC
RecruitingPhase 3
Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])
Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Squamous Carcinoma
Active, not recruitingPhase 2
Personalized Neoantigen Vaccine in Combination With Durvalumab (MEDI4736) in Extensive Stage Small Cell Lung Cancer
Extensive-stage Small Cell Lung Cancer

All Small-cell Lung Cancer trials