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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

Tracking Information
First Submitted Date  ICMJE December 22, 2019
First Posted Date  ICMJE December 26, 2019
Last Update Posted Date December 30, 2019
Estimated Study Start Date  ICMJE January 15, 2020
Estimated Primary Completion Date January 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2019)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Camrelizumab With AC in Patients With Brain Metastases of Driven Gene-negative,NSCLC
Official Title  ICMJE 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
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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Non-squamous Non-small-cell Lung Cancer
  • Brain Metastases
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Interventions:
  • Drug: Camrelizumab
  • Drug: Pemetrexed
  • Drug: Carboplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 22, 2019)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 15, 2023
Estimated Primary Completion Date January 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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-
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Li-Kun Chen +862087343410 ext +862087343410 chenlk@sysucc.ogr.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04211090
Other Study ID Numbers  ICMJE B2019-203-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Li-kun Chen, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Investigators  ICMJE
Principal Investigator: Li-Kun Chen, MD. SunYat-sen University Cancer Center
PRS Account Sun Yat-sen University
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP