Lung NeoplasmsPhase 2NCT03085069
A Study to Evaluate SHR-1210 in Patients With Advanced or Metastatic NSCLC
A Phase 2 study testing SHR-1210 in people with Lung Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, single-arm, multi-center, phase 2 Study to evaluate SHR-1210(anti-PD-1 antibody) in in adult Chinese patients with advanced or metastatic non-small cell lung cancer who failed or progressed to prior first-line systemic treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms Nec
- What is being tested?
- SHR-1210
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 3 May 2017to 20 Aug 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with histologically- or cytologically- documented NSCLC who present with Stage IIIB-IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or disease recurrence or progression following multi-modal therapy (radiation therapy, surgical resection or radical chemo-radiotherapy in locally advanced disease).
- Fresh cutting specimens or hollow needle aspiration specimens must be provided. A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (must be recent) must be available for biomarker evaluation. In the case of unstained slides, a minimum of 8 slides are necessary to conduct the planned biomarker analyses. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle.
- Subjects must have experienced disease recurrence or progression during or after one prior platinum-containing doublet chemotherapy regimen for advanced or metastatic disease:
- Subjects who received maintenance therapy (non-progressors with platinum-based doublet chemotherapy) and progressed are eligible.
- Subjects who received adjuvant or neoadjuvant platinum-doublet chemotherapy (after surgery and/or radiation therapy) and developed recurrent or metastatic disease within 6 months of completing therapy are eligible.
- Subjects with recurrent disease > 6 months after adjuvant or neoadjuvant platinum based chemotherapy, who also subsequently progressed during or after a platinum-doublet regimen given to treat the recurrence, are eligible.
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- Subjects with sensitizing EGFR mutation positive or ALK rearrangement positive, must have experienced disease recurrence or progression during or after one prior tyrosine kinase inhibitor regimen, who also have PD-L1 expression in tumor ≥ 50%, are eligible.
- Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria; Radiographic Tumor Assessment performed within 28 days of randomization.
- Eastern Cooperative Oncology Arm (ECOG) performance status of ≤ 1.
- All baseline laboratory requirements will be assessed and should be obtained within -14 days of randomization. Screening laboratory values must meet the following criteria.
- Absolute neutrophil count ≥ 1.5 × 109/L (1500/mm3)
- Platelets ≥ 80× 109/L (100,000/mm3)
- Hemoglobin ≥ 9.0 g/dL (90 g/L)
- Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN); for subjects with liver metastases, ALT and AST ≤ 5 × ULN
- Serum creatinine ≤1.5 × ULN or creatinine clearance > 45 mL/minute (using Cockcroft/Gault formula)
- 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 60 days (about 5 drug half-life + menstrual cycle) after the last dose of SHR-1210. 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 120 days (about 5 drug half-life + sperm depletion cycle) after the last dose of SHR-1210.
- Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests including completion of patient reported outcomes questionnaires and other requirements of the study. Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.
Who cannot join
- Target Disease Exceptions
- Subjects with active CNS metastases are excluded. Subjects are eligible if CNS metastases are adequately treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).
- Subjects with carcinomatous meningitis.
- Medical History and Concurrent Diseases
- Subjects with active, known or suspected autoimmune disease. Subjects in conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
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- Prior therapy with immunostimulatory medications or tumor vaccines within 6 months.
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody (including any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Treatment with any investigational agent within 5 half-life of the agent, before the first administration of study treatment.
- Subjects with a history of interstitial lung disease.
- Subjects received lung radiation therapy within 6 months.
- Other active malignancy requiring concurrent intervention.
- Subjects with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, endometrial, cervical/dysplasia) are excluded unless a complete remission was achieved at least 5 years prior to study entry.
- Subjects have had prior chemotherapy within 3 weeks prior to study, or have had prior targeted small molecule therapy within 1 weeks prior to study, or have had prior radiation therapy or surgical operation within 4 weeks prior to study, or have had prior anti-tumor biotherapy within 3 weeks prior to study. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (NCI CTCAE version 4) or baseline before administration of study drug.
- Subjects must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before the first dose of study treatment
- Subjects with active pulmonary tuberculosis.
- Subjects with hemoptysis or hemorrhagic quantity per day is 2.5 ml or above within 4 weeks prior to study.
- Physical and Laboratory Test Findings
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection. (HBV: HBsAg positive and HBV DNA ≥ 500 IU/mL ; HVC: HCV RNA positive and abnormal liver function).
- Allergies and Adverse Drug Reaction
- History of severe hypersensitivity reactions to other monoclonal antibodies.
- History of severe hypersensitivity reaction to intravenous infusion.
- Other Exclusion Criteria Any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subject's ability to comply with the study requirements, substantially increase risk to the subject, or impact the interpretability of study results.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Lung Cancer Institute (GLCI),Guangdong General Hospital (GGH)
Guangzhou, Guangdong, 510080
About this study
Official title: An Open-label, Single-arm, Multi-center, Phase 2 Study to Evaluate SHR-1210(Anti-PD-1 Antibody) in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
This is an open-label, single-arm, multi-center, phase 2 Study to evaluate SHR-1210(anti-PD-1 antibody) in in adult Chinese patients with advanced or metastatic non-small cell lung cancer who failed or progressed to prior first-line systemic treatment.
Enrolled subjects will be assigned to 4 cohorts on the basis of PD-L1 expression in tumor cells(<1%, ≥1%-25%, ≥25%-50%, ≥50%) all will be treated with the standard SHR-1210 dose (200mg) , Q2W, until documented progressive disease (PD) occurs. Subjects will return to the clinic once every two weeks. Radiographic disease assessments will be performed every 6 weeks.
The primary study hypothesis is that treatment with SHR-1210 improves Objective Response Rate when compare with standard second-line therapy, no matter how much PD-L1 expression in tumor.
Read the detailed description
In similar clinical trials, anti-PD-1 and anti-PD-L1 antibodies produce durable responses in approximately 20% of unselected patients with advanced non-small-cell lung cancer. Developing reliable, validated biomarkers that identify patients with an increased probability of response to these antibodies remains a challenge.
Because the PD-1 pathway may be a key mechanism of immune escape in a subgroup of patients with non-small-cell lung cancer, PD-L1 expression in tumor or inflammatory cells is a candidate biomarker. However, PD-L1 expression has not been formally validated as a biomarker in contemporaneously collected tumor tissue.
Additionally the purpose of the study is to assess the correlation between the expression of PD-L1 in the tumor and the response to treatment with SHR-1210 in non-small cell lung cancer.
- Conditions
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms Nec, Lung Disease, Respiratory Tract Disease, Neoplasm, Bronchial
- Being tested
- SHR-1210
- Keywords
- PD-1, PD-L1, SHR-1210
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Lung Diseases, Respiratory Tract Diseases, Bronchial Neoplasms, Carcinoma, Bronchogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1210Biological
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| PD-L1 expression in tumor ≥ 50% | Experimental | Subjects receive SHR-1210 intravenous at the dose 200mg on Day 1 every 2 weeks Receives: Biological: SHR-1210 |
| PD-L1 expression in tumor ≥25-50% | Experimental | Subjects receive SHR-1210 intravenous at the dose 200mg on Day 1 every 2 weeks Receives: Biological: SHR-1210 |
| PD-L1 expression in tumor ≥ 1-25% | Experimental | Subjects receive SHR-1210 intravenous at the dose 200mg on Day 1 every 2 weeks Receives: Biological: SHR-1210 |
| PD-L1 expression in tumor < 1% | Experimental | Subjects receive SHR-1210 intravenous at the dose 200mg on Day 1 every 2 weeks Receives: Biological: SHR-1210 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response is defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
Measured: Determined using RECIST v1.1 criteria, up to approximately 1 year
Secondary outcomes (4)
Duration of Response Rate
Measured: Determined using RECIST v1.1 criteria, up to approximately 1 year
Overall Survival Rate at 12-month
Measured: up to approximately 1 year
Progression-Free Survival
Measured: Determined using RECIST v1.1 criteria, up to approximately 1 year
Number of participants with treatment-related adverse events (AEs)
assessed by 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 posted21 Mar 2017
- Study start3 May 2017
- Primary completion20 Aug 2020
- Study completion20 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Shi, MD, Study director, Jiangsu Hengrui Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085069
- Sponsor's protocol ID
- SHR-1210-II-201-NSCLC
- Status last verified
- Feb 2023
- First submitted
- 15 Mar 2017
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yang JJ, Huang C, Fan Y, Pan H, Feng J, Jiang L, Li XY, Liu XQ, Xiong JP, Zhao YQ, Cheng Y, Ma R, Wang J, Wang Y, Liu YH, Lin DM, Wang T, Shi W, Zou J, Wu YL. Camrelizumab in different PD-L1 expression cohorts of pre-treated advanced or metastatic non-small cell lung cancer: a phase II study. Cancer Immunol Immunother. 2022 Jun;71(6):1393-1402. doi: 10.1007/s00262-021-03091-3. Epub 2021 Oct 20.
PubMed 34668977
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. 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(Anti-PD-1 Antibody) in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03085069
- Acronym / sponsor ID
- SHR-1210-II-201-NSCLC
- Conditions
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms Nec, Lung Disease, Respiratory Tract Disease, Neoplasm, Bronchial
- Keywords
- PD-1, PD-L1, SHR-1210
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 May 2017 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 20 Aug 2023 (estimated)
- First posted
- 21 Mar 2017 (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.
This is an open-label, single-arm, multi-center, phase 2 Study to evaluate SHR-1210(anti-PD-1 antibody) in in adult Chinese patients with advanced or metastatic non-small cell lung cancer who failed or progressed to prior first-line systemic treatment.
Enrolled subjects will be assigned to 4 cohorts on the basis of PD-L1 expression in tumor cells(<1%, ≥1%-25%, ≥25%-50%, ≥50%) all will be treated with the standard SHR-1210 dose (200mg) , Q2W, until documented progressive disease (PD) occurs. Subjects will return to the clinic once every two weeks. Radiographic disease assessments will be performed every 6 weeks.
The primary study hypothesis is that treatment with SHR-1210 improves Objective Response Rate when compare with standard second-line therapy, no matter how much PD-L1 expression in tumor.
Detailed description
In similar clinical trials, anti-PD-1 and anti-PD-L1 antibodies produce durable responses in approximately 20% of unselected patients with advanced non-small-cell lung cancer. Developing reliable, validated biomarkers that identify patients with an increased probability of response to these antibodies remains a challenge.
Because the PD-1 pathway may be a key mechanism of immune escape in a subgroup of patients with non-small-cell lung cancer, PD-L1 expression in tumor or inflammatory cells is a candidate biomarker. However, PD-L1 expression has not been formally validated as a biomarker in contemporaneously collected tumor tissue.
Additionally the purpose of the study is to assess the correlation between the expression of PD-L1 in the tumor and the response to treatment with SHR-1210 in non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PD-L1 expression in tumor ≥ 50% | Experimental | Biological: SHR-1210Subjects receive SHR-1210 intravenous at the dose 200mg on Day 1 every 2 weeks |
| PD-L1 expression in tumor ≥25-50% | Experimental | Biological: SHR-1210Subjects receive SHR-1210 intravenous at the dose 200mg on Day 1 every 2 weeks |
| PD-L1 expression in tumor ≥ 1-25% | Experimental | Biological: SHR-1210Subjects receive SHR-1210 intravenous at the dose 200mg on Day 1 every 2 weeks |
| PD-L1 expression in tumor < 1% | Experimental | Biological: SHR-1210Subjects receive SHR-1210 intravenous at the dose 200mg on Day 1 every 2 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Subjects with histologically- or cytologically- documented NSCLC who present with Stage IIIB-IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or disease recurrence or progression following multi-modal therapy (radiation therapy, surgical resection or radical chemo-radiotherapy in locally advanced disease).
- Fresh cutting specimens or hollow needle aspiration specimens must be provided. A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (must be recent) must be available for biomarker evaluation. In the case of unstained slides, a minimum of 8 slides are necessary to conduct the planned biomarker analyses. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle.
- Subjects must have experienced disease recurrence or progression during or after one prior platinum-containing doublet chemotherapy regimen for advanced or metastatic disease:
- Subjects with sensitizing EGFR mutation positive or ALK rearrangement positive, must have experienced disease recurrence or progression during or after one prior tyrosine kinase inhibitor regimen, who also have PD-L1 expression in tumor ≥ 50%, are eligible.
- Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria; Radiographic Tumor Assessment performed within 28 days of randomization.
Key exclusion criteria (24 listed)
- Target Disease Exceptions
- Medical History and Concurrent Diseases
- Physical and Laboratory Test Findings
- Allergies and Adverse Drug Reaction
- Other Exclusion Criteria Any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subject's ability to comply with the study requirements, substantially increase risk to the subject, or impact the interpretability of study results.
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 is a humanized anti-PD1 IgG4 monoclonal antibody | Biological | PD-L1 expression in tumor < 1%, PD-L1 expression in tumor ≥ 1-25%, PD-L1 expression in tumor ≥ 50%, PD-L1 expression in tumor ≥25-50% |
Primary outcome
Objective response rate
Time frame: Determined using RECIST v1.1 criteria, up to approximately 1 year
Objective response is defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
4 secondary outcomes
Duration of Response Rate
Time frame: Determined using RECIST v1.1 criteria, up to approximately 1 year
Overall Survival Rate at 12-month
Time frame: up to approximately 1 year
Progression-Free Survival
Time frame: Determined using RECIST v1.1 criteria, up to approximately 1 year
Number of participants with treatment-related adverse events (AEs)
Time frame: up to approximately 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Derived from this study: PubMed 34668977Yang JJ, Huang C, Fan Y, Pan H, Feng J, Jiang L, Li XY, Liu XQ, Xiong JP, Zhao YQ, Cheng Y, Ma R, Wang J, Wang Y, Liu YH, Lin DM, Wang T, Shi W, Zou J, Wu YL. Camrelizumab in different PD-L1 expression cohorts of pre-treated advanced or metastatic non-small cell lung cancer: a phase II study. Cancer Immunol Immunother. 2022 Jun;71(6):1393-1402. doi: 10.1007/s00262-021-03091-3. Epub 2021 Oct 20.
- Individual participant dataSharing planned: Undecided
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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.
Wei Shi, MD study director
Jiangsu Hengrui Pharmaceutical 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 in people with Lung Neoplasms and 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 18 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 16 Feb 2023. 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?
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 (time frame: Determined using RECIST v1.1 criteria, up to approximately 1 year). 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 NCT03085069, 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 16 Feb 2023; AzTrials last refreshed its copy on 31 Oct 2026.