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Camrelizumab With AC in Patients With Brain Metastases of Driven Gene-negative,NSCLC (CAP-BRAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04211090
Recruitment Status : Recruiting
First Posted : December 26, 2019
Last Update Posted : December 30, 2019
Sponsor:
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Li-kun Chen, Sun Yat-sen University

Brief Summary:
The primary hypothesis is that camrelizumab in combination with pemetrexed/ carboplatin will present a better efficacy for treatment of first line metastatic non-squamous non-small cell lung cancer and minimize the risk of toxicity

Condition or disease Intervention/treatment Phase
Non-squamous Non-small-cell Lung Cancer Brain Metastases Drug: Camrelizumab Drug: Pemetrexed Drug: Carboplatin Phase 2

Detailed Description:
This is a prospective, open-label, phase Ⅱ studyto evaluate the efficacy and safetyof camrelizumab combined with pemetrexed/ carboplatin in participants with brain metastases ofnon-squamous non-small cell lung cancer.Paticipant was confirmed without EGFR activating mutation or ALK fusion, and received no prior systemic therapy.Patients would receive camrelizumab in combination with pemetrexed/ carboplatin for 4 cycles,followed by camrelizumab and pemetrexed as maitenance treatment until progression, camrelizumab will be administered no more than 24 months. PD-L1 expression assessed with 22C3 pharmDx assay will be used as a stratification factor.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Intervention Model: Single Group Assignment
Intervention Model Description: patients with brain metastases of driven gene-negative, non-squamous non-small cell lung cancer
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Evaluate Camrelizumab With Pemetrexed / Carboplatin in Patients With Brain Metastases of Driven Gene-negative, Non-squamous Non-small Cell Lung Cancer
Estimated Study Start Date : January 15, 2020
Estimated Primary Completion Date : January 15, 2022
Estimated Study Completion Date : July 15, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Camrelizumab with pemetrexed / carboplatin
Camrelizumab with pemetrexed / carboplatin in patients with brain metastases of driven gene-negative, non-squamous non-small cell lung cancer
Drug: Camrelizumab
Camrelizumab with pemetrexed / carboplatin in patients with brain metastases of driven gene-negative, non-squamous non-small cell lung cancer, Participants receive a 3-week cycle (Q3W) treatment,Treatment continued until disease progression or unacceptable toxicity or death or, for the immunotherapy regimens

Drug: Pemetrexed
Camrelizumab with pemetrexed / carboplatin in patients with brain metastases of driven gene-negative, non-squamous non-small cell lung cancer, Participants receive a 3-week cycle (Q3W) treatment,Treatment continued until disease progression or unacceptable toxicity or death or, for the immunotherapy regimens

Drug: Carboplatin
Camrelizumab with pemetrexed / carboplatin in patients with brain metastases of driven gene-negative, non-squamous non-small cell lung cancer, Participants receive a 3-week cycle (Q3W) treatment,Treatment continued until disease progression or unacceptable toxicity or death or, for the immunotherapy regimens




Primary Outcome Measures :
  1. Intracranial Objective Response Rate (iORR) [ Time Frame: 3.5year ]
    iORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response(PR: ≥30% decrease in the sum of diameters of target lesions) in brain lesion per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1


Secondary Outcome Measures :
  1. Intracranial Progression-Free Survival(iPFS) [ Time Frame: 3.5year ]
    Intracranial Progression-free survival is defined as the duration from date of enrollment to the first occurrence of progression in brain metastasis disease or death from any cause

  2. Objective Response Rate (ORR) [ Time Frame: 3.5year ]
    ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  3. Progression-free Survival (PFS) [ Time Frame: 3.5year ]
    Progression-free survival is defined as the duration from date of enrollment to the first occurrence of progression of disease or death from any cause

  4. Incidence of Adverse Events (AEs) [ Time Frame: 3.5year ]
    Incidence of Adverse Events (AEs) in the treatment of Camrelizumab combined with pemetrexed / carboplatin for patients with brain metastasis according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histological or cytological diagnosis of non-squamous non-small cell lung cancer(NSCLC)
  2. Subjects with asymptomatic brain metastasis or the symptoms of intracranial hypertension were relieved after dehydration treatment, and kept clinically stable for ≥ 2 weeks. Subjects who need hormone dehydration treatment, hormone therapy should be stopped 3 days before the first dose of the investigational drugs;
  3. MRI confirmed brain parenchyma metastasis, ≥ 3 brain lesions, or 1-2 brain lesions but not suitable for local treatment or refused local treatment. At least one brain measurable lesion ≥ 5mm using RECIST 1.1 criteria.,
  4. Subjects have not received prior systemic treatment for metastatic NSCLC.
  5. Tumor tissue biomarkers examination should be complied with: 1) Subjects should not have a previously detected sensitizing EGFR mutation or ALK fusion oncogene. 2) Subjects should have sufficient tissue samples for PD-L1 detection (IHC,DAKO 22C3 pharmDx).
  6. age:18~75years
  7. ECOG performance status of 0 or 1.
  8. Life expectancy ≥ 3 months.
  9. Blood routine examination should be complied with (No blood transfusion, no use of hematopoietic factors and no use of drugs for correction within 7 days):

    1. ANC ≥ 1.5×109/L;
    2. PLT ≥ 100×109/L;
    3. HB ≥ 90 g/L;
  10. Has adequate organ function,Biochemical tests must meet the following criteria:

    TBIL ≤ 1.5ULN; ALT、AST≤ 2.5 ULN (If abnormal liver function is caused by liver metastasis, ALT、AST< 5ULN; Cr≤1.5ULN,endogenous creatinine clearance rate≥60ml/min(Cockcroft-Gault formula);

  11. Blood coagulation must meet the following criteria: INR≤1.5 and APTT≤1.5 ULN;
  12. Women of childbearing age must undergo a serological pregnancy test within 7 days before the first dose with negative results and willing to use a medically approved and effective contraceptive method (e.g. intrauterine device, contraceptive pill or condom) during the study and within two months after the last dose. For male subjects whose partners are women of childbearing age, they should be sterilized surgically or agree to use effective contraceptive methods during the study and within two months after the last dose.
  13. Subjects should be able to follow the research and follow-up procedures;
  14. Subjects should be voluntarily participate in clinical studies and informed consent should be signed.

Exclusion Criteria:

  1. Subjects with predominantly squamous cell histology NSCLC, or SCLC.
  2. brain metastases with hemorrhage;
  3. Participated in other clinical trials, or finish other clinical trials within 4 weeks.
  4. Subjects have received prior systemic treatment for metastatic NSCLC;
  5. Subjects have received solid organ or blood system transplantation;
  6. active autoimmune diseases requiring systemic treatment (such as the use of disease remission drugs, corticosteroids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapy (such as thyroxine, insulin or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy;
  7. systemic glucocorticoid therapy or any other form of immunosuppressive therapy is being given within 7 days before the first administration of the study; physiological doses of glucocorticoids are allowed (prednisone or equivalent for ≤ 10 mg/ days);
  8. within 1 year before the first administration, there was a history of non-infectious pneumonia or interstitial lung disease requiring glucocorticoid treatment;
  9. Subjects with congenital or acquired immunodeficiency such as HIV infection, active hepatitis B (HBV DNA ≥ 200 IU/ml), hepatitis C (hepatitis C antibody is positive).
  10. Women who are pregnant or lactating
  11. Known history of hypersensitivity to any components of the Camrelizumab formulation,or other monoclonal antibody.
  12. Known history of hypersensitivity to pemetrexed, carboplatin or any of its excipients;
  13. A prior malignancy other than NSCLC, except carcinoma in situ of the cervix or non-melanoma skin cancer, adequately treated low grade [Gleason score <6] localized prostate cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence-

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04211090


Contacts
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Contact: Li-Kun Chen +862087343410 ext +862087343410 chenlk@sysucc.ogr.cn

Locations
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China, Guangzhou
Li-Kun Chen Recruiting
Guangzhou, Guangzhou, China, 510006
Contact: Li-Kun Chen    +862087343410 ext +862087343410    chenlk@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Li-Kun Chen, MD. SunYat-sen University Cancer Center

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Responsible Party: Li-kun Chen, director physician, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04211090    
Other Study ID Numbers: B2019-203-01
First Posted: December 26, 2019    Key Record Dates
Last Update Posted: December 30, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Li-kun Chen, Sun Yat-sen University:
Non-squamous Non-small-cell Lung Cancer
Brain Metastases
Additional relevant MeSH terms:
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Lung Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Bronchial Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Carcinoma, Non-Small-Cell Lung
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Neoplastic Processes
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Carboplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors