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Lung NeoplasmsPhase 3NCT03134872

A Study of SHR-1210 in Combination With Pemetrexed and Carboplatin in Subjects With Non-squamous NSCLC

A Phase 3 study testing SHR-1210, Carboplatin and Pemetrexed in people with Lung Neoplasms and 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

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is a randomized,Phase III, multicenter ,open-label study designed to evaluate the safety and efficacy of SHR-1210 with carboplatin and pemetrexed versus carboplatin-pemetrexed in subjects who are chemotherapy naive and have Stage IIIB/IV non-squamous… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
SHR-1210, Carboplatin and Pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
419 participants
Where
1 siteChina
Study dates
12 May 2017to 29 Aug 2019
Phase
Phase 3
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Subjects who are chemotherapy naive and have Stage IIIB-IV non-squamous NSCLC.
  • 2. Subjects should not have a previously detected sensitizing EGFR mutation or ALK fusion oncogene.
  • 3. Fresh cutting or ≤6 months preservation specimens must be provided.
  • 4. No prior systemic treatment. Subjects who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment free interval of at least 12 months from randomization since the last chemotherapy cycle.
  • 5. Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria;
  • 6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
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  • 7. Have a life expectancy of at least 3 months.
  • 8. All baseline laboratory requirements will be assessed and should be obtained within 14 days prior to the first administration of study treatment.
  • 9. Female Subjects of childbearing potential must have a negative serum pregnancy test within 3 days before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 180 days after the last dose of study treatment.
  • 10. Male Subjects with a female partner(s) of child-bearing potential must be willing to use very efficient barrier methods of contraception for the course of the study through 180 days after the last dose of study treatment.
  • 11. Subjects has voluntarily agreed to participate by giving written informed consent/assent for the trial. The subject may also provide consent/assent for Future Biomedical Research.

Who cannot join

  • 1. Target Disease Exceptions
  • Subjects with predominantly squamous cell histology NSCLC, or SCLC.
  • Subjects with epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) translocation.
  • Subjects with no measurable disease by CT or MRI per RECIST 1.1 criteria.
  • Subjects with carcinomatous meningitis, or symptoms of spinal cord compression.
  • Subjects with active CNS metastases are excluded.
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  • Subjects who can receive surgical resection or radical radiotherapy.
  • 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).
  • 2. 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, or not requiring systemic treatment 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.
  • Prior therapy with systemic immunostimulatory agents within 1 months of the first dose of trial treatment.
  • Subjects are currently participating and receiving study therapy or had participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks or 5 half-value period life of the agent, before the first dose of trial treatment.
  • Subjects who expected to require any other form of antineoplastic therapy while on study (including maintenance therapy with another agent for NSCLC).
  • Subjects received major surgery or radiation therapy of > 30 Gy not to chest within 4 weeks of the first dose of study treatment, or radiation therapy of > 30 Gy to chest within 24 weeks of the first dose of study treatment, or radiation therapy of < 30 Gy to chest within 2 weeks of the first dose of study treatment, and had not recovered from the toxicity and/or complications of the most recent prior chemotherapy to Grade 1 or less (except alopecia or fatigue).
  • Subjects with a history of interstitial lung disease, or other disease may interfere with the detection or treatment of suspected drug-related lung toxicity.
  • Other active malignancy requiring concurrent intervention.
  • Subjects with previous malignancies (except non-melanoma skin cancers, and thefollowing in situ cancers: bladder, endometrial, cervical/dysplasia) are excluded unless a complete remission was achieved at least 5 years prior to study entry.
  • Subjects with clinically significant cardiovascular and cerebrovascular diseases.
  • Subjects with active pulmonary tuberculosis.
  • Subjects have severe infections within 4 weeks of the first dose of study treatment.
  • Subjects had or plan to have allogeneic bone marrow transplantation or solid organ transplant.
  • Subjects had administration of a live, attenuated vaccine within 30 days of the first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study.
  • Subjects with contraindications to platinum therapy.
  • 3. Physical and Laboratory Test Findings
  • Known history of testing positive for human immunodeficiency virus (HIV) or
  • known acquired immunodeficiency syndrome (AIDS).
  • Known history of active Hepatitis B or C.
  • Subjects with severe pleural effusion, pericardial effusion, or ascites need repeated drainage.
  • 4. History of severe hypersensitivity reactions to other monoclonal antibodies, or intravenous infusion, or carboplatin, or pemetrexed.
  • 5. Subjects have known psychiatric or substance abuse disorder (including alcohol\smoking), or be regular user (including "recreational use") of any illicit drugs that would interfere with cooperation with the requirements of the trial.
  • 6. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tongji University, Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

Other trials in China

About this study

Official title: A Phase III, Randomized, Open-Label, Multi-center Study of SHR-1210(Anti-PD-1 Antibody) in Combination With Pemetrexed and Carboplatin as First Line Therapy in Subjects With Advanced/Metastatic Non-squamous Non-small Cell Lung Cancer

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is a randomized,Phase III, multicenter ,open-label study designed to evaluate the safety and efficacy of SHR-1210 with carboplatin and pemetrexed versus carboplatin-pemetrexed in subjects who are chemotherapy naive and have Stage IIIB/IV non-squamous NSCLC.

The primary hypothesis is that SHR-1210 combined with carboplatin and pemetrexed prolongs Progression Free Survival (PFS) in per RECIST 1.1 by blinded independent central review (ITT population and population was indicated by high PD-L1 expression) compared to carboplatin and pemetrexed treatment .

Read the detailed description

In this study, subjects will be randomly assigned to receive either carboplatin and pemetrexed for 4-6 cycles followed by pemetrexed maintenance until progression or unacceptable toxicity, OR receive SHR-1210 combined with carboplatin and pemetrexed chemotherapy for 4-6 cycles followed by pemetrexed maintenance with SHR-1210 until progression or unacceptable toxicity (SHR-1210 for a maximum of 2 years).

Subjects assigned to the chemotherapy arm will have the opportunity to crossover to receive SHR-1210 monotherapy once they experience progression of disease (PD) defined by RECIST 1.1 and meet all the crossover criteria.

Being tested
SHR-1210, Carboplatin, Pemetrexed
Keywords
PD-1, PD-L1, SHR-1210, Carboplatin, Pemetrexed
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms, Thoracic Neoplasms, Lung Diseases, Respiratory Tract Diseases, Neoplasms by Site, Bronchial Neoplasms

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.

  • CarboplatinDrug

    Carboplatin

  • PemetrexedDrug

    Pemetrexed

Study groups in NCT03134872
Study groupRoleWhat they receive
SHR-1210+ChemotherapyExperimentalSubjects receive SHR-1210 200mg and pemetrexed 500 mg/m^2 and carboplatin AUC 5, administered as IV infusion on Day 1 of each 21-day cycle for 4-6 cycles followed by optional SHR-1210 200mg and pemetrexed 500 mg/m^2 every three weeks (Q3W) maintenance for the remainder of the study or until documented PD.
Receives: Biological: SHR-1210; Drug: Carboplatin; Drug: Pemetrexed
ChemotherapyActive comparatorSubjects receive pemetrexed 500 mg/m^2 and carboplatin Area Under the Curve (AUC) 5, administered as IV infusion on Day 1 of each 21-day cycle for 4-6 cycles followed by optional pemetrexed 500 mg/m^2 every three weeks (Q3W) maintenance for the remainder of the study or until documented PD. If PD occurs, Subjects may be able to receive SHR-1210 Q3W for the remainder of the study or until documented PD.
Receives: Drug: Carboplatin; Drug: Pemetrexed

What is being measured

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

  1. Progression-Free Survival in the intent-to-treat (ITT) population

    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 24 months

  2. Progression-Free Survival in the PD-L1-selected population

    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 24 months

Secondary outcomes (6)

  1. Overall Response Rate (ORR)

    Determined using RECIST v1.1 criteria

    Measured: up to 24 months

  2. Duration of Response Rate(DoR)

    Determined using RECIST v1.1 criteria

    Measured: up to 24 months

  3. Time To Progression (TTP)

    Determined using RECIST v1.1 criteria

    Measured: up to 24 months

  4. Disease Control Rate (DCR)

    Determined using RECIST v1.1 criteria

    Measured: up to 24 months

  5. Overall Survival

    Defined as the time from randomization to death from any cause.

    Measured: up to 24 months

  6. Number of Subjects with treatment-related adverse events (AEs)

    Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.

    Measured: up to 24 months

Timeline

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

  1. First posted1 May 2017
  2. Study start12 May 2017
  3. Primary completion27 Jul 2019
  4. Study completion29 Aug 2019

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
419 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03134872
Sponsor's protocol ID
SHR-1210-III-303-NSCLC
Status last verified
Jun 2020
First submitted
25 Apr 2017
Last updated
9 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhou C, Chen G, Huang Y, Zhou J, Lin L, Feng J, Wang Z, Shu Y, Shi J, Hu Y, Wang Q, Cheng Y, Wu F, Chen J, Lin X, Wang Y, Huang J, Cui J, Cao L, Liu Y, Zhang Y, Pan Y, Zhao J, Wang L, Chang J, Chen Q, Ren X, Zhang W, Fan Y, He Z, Fang J, Gu K, Dong X, Jin F, Gao H, An G, Ding C, Jiang X, Xiong J, Zhou X, Hu S, Lu P, Liu A, Guo S, Huang J, Zhu C, Zhao J, Gao B, Chen Y, Hu C, Zhang J, Zhang H, Zhao H, Wang Z, Ma X, Shi W. Camrelizumab plus carboplatin and pemetrexed as first-line therapy for advanced non-squamous non-small-cell lung cancer: 5-year outcomes of the CameL randomized phase 3 study. J Immunother Cancer. 2024 Nov 27;12(11):e009240. doi: 10.1136/jitc-2024-009240.

    PubMed 39608979

  • Zhou C, Chen G, Huang Y, Zhou J, Lin L, Feng J, Wang Z, Shu Y, Shi J, Hu Y, Wang Q, Cheng Y, Wu F, Chen J, Lin X, Wang Y, Huang J, Cui J, Cao L, Liu Y, Zhang Y, Pan Y, Zhao J, Wang L, Chang J, Chen Q, Ren X, Zhang W, Fan Y, He Z, Fang J, Gu K, Dong X, Jin F, Gao H, An G, Ding C, Jiang X, Xiong J, Zhou X, Hu S, Lu P, Liu A, Guo S, Huang J, Zhu C, Zhao J, Gao B, Chen Y, Hu C, Zhang J, Zhang H, Zhao H, Tai Y, Ma X, Shi W; CameL Study Group. Camrelizumab Plus Carboplatin and Pemetrexed as First-Line Treatment for Advanced Nonsquamous NSCLC: Extended Follow-Up of CameL Phase 3 Trial. J Thorac Oncol. 2023 May;18(5):628-639. doi: 10.1016/j.jtho.2022.12.017. Epub 2023 Jan 13.

    PubMed 36646210

  • Wu F, Jiang T, Chen G, Huang Y, Zhou J, Lin L, Feng J, Wang Z, Shu Y, Shi J, Hu Y, Wang Q, Cheng Y, Chen J, Lin X, Wang Y, Huang J, Cui J, Cao L, Liu Y, Zhang Y, Pan Y, Zhao J, Wang L, Chang J, Chen Q, Ren X, Zhang W, Fan Y, He Z, Fang J, Gu K, Dong X, Zhang T, Shi W, Zou J, Bai X, Ren S, Zhou C; CameL Study Group. Multiplexed imaging of tumor immune microenvironmental markers in locally advanced or metastatic non-small-cell lung cancer characterizes the features of response to PD-1 blockade plus chemotherapy. Cancer Commun (Lond). 2022 Dec;42(12):1331-1346. doi: 10.1002/cac2.12383. Epub 2022 Nov 4.

    PubMed 36331328

  • Xie Q, Zheng H, Su N, Li Q. Camrelizumab in patients with advanced non-squamous non-small cell lung cancer: a cost-effective analysis in China. BMJ Open. 2022 Aug 5;12(8):e061592. doi: 10.1136/bmjopen-2022-061592.

    PubMed 36194670

  • Chen T, Xie R, Zhao Q, Cai H, Yang L. Cost-Utility Analysis of Camrelizumab Plus Chemotherapy Versus Chemotherapy Alone as a First-Line Treatment for Advanced Nonsquamous Non-Small Cell Lung Cancer in China. Front Oncol. 2022 Jul 22;12:746526. doi: 10.3389/fonc.2022.746526. eCollection 2022.

    PubMed 35936702

  • Zhou C, Chen G, Huang Y, Zhou J, Lin L, Feng J, Wang Z, Shu Y, Shi J, Hu Y, Wang Q, Cheng Y, Wu F, Chen J, Lin X, Wang Y, Huang J, Cui J, Cao L, Liu Y, Zhang Y, Pan Y, Zhao J, Wang L, Chang J, Chen Q, Ren X, Zhang W, Fan Y, He Z, Fang J, Gu K, Dong X, Zhang T, Shi W, Zou J; CameL Study Group. Camrelizumab plus carboplatin and pemetrexed versus chemotherapy alone in chemotherapy-naive patients with advanced non-squamous non-small-cell lung cancer (CameL): a randomised, open-label, multicentre, phase 3 trial. Lancet Respir Med. 2021 Mar;9(3):305-314. doi: 10.1016/S2213-2600(20)30365-9. Epub 2020 Dec 18.

    PubMed 33347829

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SHR-1210, Carboplatin and Pemetrexed 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 11 inclusion and 32 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 9 Jun 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression-Free Survival in the intent-to-treat (ITT) population (time frame: up to 24 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 NCT03134872, which also lists 6 linked publications.

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 9 Jun 2020.

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