Lung NeoplasmsPhase 2NCT03666728
A Study of SHR-1210 in Combination With BP102 in Subjects With Non-squamous NSCLC
A Phase 2 study testing SHR-1210 and BP102 in people with Lung Neoplasms, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is a Phase II, multicenter, open-label study designed to evaluate the safety and efficacy of SHR-1210 with BP102 in subjects who are chemotherapy naive and have Stage IIIB~IV non-squamous NSCLC. The primary end points are ORR and PFS. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- SHR-1210 and BP102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2018to 11 Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1;
- Subjects who are chemotherapy naive and have Stage IIIB-IV non-squamous NSCLC;
- Gene diagnostic tests must show that subjects are with wild type of EGFR, ALK and ROS1;
- Known PD-L1 status as determined by immunohistochemistry assay performed on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening;
- No prior systemic treatment;
- Adequate hematologic and end organ function;
- Female participants of childbearing potential must have a negative serum pregnancy test within -7 days of randomization and must be willing to use very efficient barrier methods of contraception or a barrier method plus a hormonal method starting with the screening visit through 6 months after the last dose Male participants with a female partner(s) of child-bearing potential must be willing to use very efficient barrier methods of contraception from screening through 6 months after the last dose.
Who cannot join
- Significant cardiovascular disease;
- Prior treatment with immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies;
- History of autoimmune disease;
- Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome;
- Severe infection within 4 weeks prior to randomization;
- Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation that such a live attenuated vaccine will be required during the study;
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- Major surgical procedure within 4 weeks prior to randomization;
- History of hemoptysis within 12 weeks prior to randomization;
- Inadequately controlled hypertension;
- Evidence of bleeding diathesis or coagulopathy;
- Prior allogeneic bone marrow transplantation or solid organ transplant;
- Positive test for HIV, and patients with active hepatitis B or hepatitis C.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-arm, Multi-center, Phase 2 Study to Evaluate SHR-1210 Combination With BP102 in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Whose PD-L1 Positive and EGFR/ALK Wild Type.
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is a Phase II, multicenter, open-label study designed to evaluate the safety and efficacy of SHR-1210 with BP102 in subjects who are chemotherapy naive and have Stage IIIB~IV non-squamous NSCLC. The primary end points are ORR and PFS.
In this study, subjects will receive SHR-1210 combined with BP102 until progression or unacceptable toxicity (SHR-1210 or BP102 for a maximum of 2 years).
- Conditions
- Lung Neoplasms
- Being tested
- SHR-1210, BP102
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1210Drug
SHR-1210 was administered 200 mg iv every 3 weeks
BP102Drug
BP102 was administered 15 mg/kg iv every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| SHR-1210+BP102 | Experimental | Subjects receive SHR-1210 200 mg and BP102 15 mg/kg in day 1 intravenously every 3 weeks, until disease progression or unacceptable toxicity. Receives: Drug: SHR-1210; Drug: BP102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR, determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
Measured: up to approximately 1 year
Progression-Free Survival (PFS)
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.
Measured: up to approximately 1 year
Secondary outcomes (5)
Time to Response (TTR)
Determined using RECIST v1.1 criteria
Measured: up to approximately 1 year
Duration of Response Rate (DoR)
Determined using RECIST v1.1 criteria
Measured: up to approximately 1 year
Disease Control Rate (DCR)
Determined using RECIST v1.1 criteria
Measured: up to approximately 1 year
Overall Survival Rate at 12-month (OSR)
Measured: up to 1 year
Number of participants with treatment-related adverse events (AEs)
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.
Measured: up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start30 Nov 2018
- Primary completion11 Mar 2020
- Study completion11 Mar 2020
Why it stopped: changes in the R\&D strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiangsu HengRui Medicine Co., Ltd., Study director, Jiangsu HengRui Medicine Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666728
- Sponsor's protocol ID
- SHR-1210-II-211
- Status last verified
- Mar 2021
- First submitted
- 10 Sep 2018
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Multi-center, Phase 2 Study to Evaluate SHR-1210 Combination With BP102 in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Whose PD-L1 Positive and EGFR/ALK Wild Type.
- ClinicalTrials.gov ID
- NCT03666728
- Acronym / sponsor ID
- SHR-1210-II-211
- Conditions
- Lung Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: changes in the R\&D strategy
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is a Phase II, multicenter, open-label study designed to evaluate the safety and efficacy of SHR-1210 with BP102 in subjects who are chemotherapy naive and have Stage IIIB~IV non-squamous NSCLC. The primary end points are ORR and PFS.
In this study, subjects will receive SHR-1210 combined with BP102 until progression or unacceptable toxicity (SHR-1210 or BP102 for a maximum of 2 years).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-1210+BP102 | Experimental | Drug: SHR-1210, Drug: BP102Subjects receive SHR-1210 200 mg and BP102 15 mg/kg in day 1 intravenously every 3 weeks, until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1;
- Subjects who are chemotherapy naive and have Stage IIIB-IV non-squamous NSCLC;
- Gene diagnostic tests must show that subjects are with wild type of EGFR, ALK and ROS1;
- Known PD-L1 status as determined by immunohistochemistry assay performed on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening;
- No prior systemic treatment;
Key exclusion criteria (12 listed)
- Significant cardiovascular disease;
- Prior treatment with immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies;
- History of autoimmune disease;
- Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome;
- Severe infection within 4 weeks prior to randomization;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-1210SHR-1210 was administered 200 mg iv every 3 weeks | Drug | SHR-1210+BP102 |
| BP102BP102 was administered 15 mg/kg iv every 3 weeks | Drug | SHR-1210+BP102 |
Primary outcome
Objective response rate (ORR)
Time frame: up to approximately 1 year
ORR, determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
Progression-Free Survival (PFS)
Time frame: up to approximately 1 year
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.
5 secondary outcomes
Time to Response (TTR)
Time frame: up to approximately 1 year
Duration of Response Rate (DoR)
Time frame: up to approximately 1 year
Disease Control Rate (DCR)
Time frame: up to approximately 1 year
Overall Survival Rate at 12-month (OSR)
Time frame: up to 1 year
Number of participants with treatment-related adverse events (AEs)
Time frame: up to approximately 1 year
Results and safety
The study was stopped early (reason given: changes in the R\&D strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiangsu HengRui Medicine Co., Ltd. study director
Jiangsu HengRui Medicine Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1210 and BP102 in people with Lung Neoplasms, 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 7 inclusion and 12 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: stopped early, as of the sponsor's last update on 17 Mar 2021. 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?
The study was stopped early (reason given: changes in the R\&D strategy). Results are not available in the source record.
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?
Objective response rate (ORR) (time frame: up to approximately 1 year). 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?
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 17 Mar 2021.