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Study of Autologous CIK Cell Immunotherapy Combination With PD-1 Inhibitor and Chemotherapy in the Advanced NSCLC

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: NCT03987867
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

Tracking Information
First Submitted Date  ICMJE June 12, 2019
First Posted Date  ICMJE June 17, 2019
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2020)
Objective response rate (ORR) [ Time Frame: 2 years ]
ORR was calculated by the percentage of patients with a confirmed complete (CR) or partial response (PR).
Original Primary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
Progression-free survival [ Time Frame: 2 years ]
PFS will be calculated from initiation of treatment until first progression, and patients alive in stable state will be censored at the time of last contact.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Autologous CIK Cell Immunotherapy Combination With PD-1 Inhibitor and Chemotherapy in the Advanced NSCLC
Official Title  ICMJE Phase I Clinical Study of Autologous CIK Cell Immunotherapy Combination With PD-1 Inhibitor and Chemotherapy in the First-line Treatment of IIIB/IIIC/IV Non-Small Cell Lung Cancer
Brief Summary This prospective, unicentric, open-labe phase I study is to evaluate the effects of autologous cytokine-induced killer cell immunotherapy combination with PD-1 inhibitor and chemotherapy in the first-line treatment of IIIB/IIIC/IV non-small cell lung cancer.
Detailed Description In the non-squamous NSCLC, patients received sintilimab Injection (PD-1 inhibitor) 200mg, d1; pemetrexed injection 500mg/m2, d1; carboplatin injection AUC 5, d1; CIK cells venous re-transfusion >=1x10^10, d14; Q3W, for 4 cycles. Then sintilimab and pemetrexed maintenance treatment for 2 years. In the squamous NSCLC, patients received sintilimab Injection (PD-1 inhibitor) 200mg, d1; liposome paclitaxel injection 135mg/m2, d1; carboplatin injection AUC 5, d1; CIK cells venous re-transfusion >=1x10^10, d14; Q3W, for 4 cycles. Then sintilimab maintenance treatment for 2 years.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-small Cell Lung Cancer
  • First-line Treatment
Intervention  ICMJE
  • Biological: CIK cell
    CIK cell injection
    Other Name: Autologous cytokine-induced killer cells
  • Biological: Sintilimab Injection
    IBI308 injection
    Other Name: PD-1 inhibitor
  • Drug: Pemetrexed
    Pemetrexed injection
  • Drug: Liposome paclitaxel
    Liposome paclitaxel injection
  • Drug: Carboplatin
    Carboplatin injection
Study Arms  ICMJE Experimental: Arm: CIK+PD-1 inhibitor+chemotherapy

CIK cell, IBI308, Pemetrexed, Liposome paclitaxel, Carboplatin

IBI308 intravenous infusion 200mg d1; Pemetrexed intravenous infusion 500mg/m2 d2 or Liposome paclitaxel intravenous infusion 135mg/m2 d2; Carboplatin intravenous infusion AUC5 d2; CIK cells, 1x10^10 (10 billion ), intravenous infusion,d14; Q3W.

Interventions:
  • Biological: CIK cell
  • Biological: Sintilimab Injection
  • Drug: Pemetrexed
  • Drug: Liposome paclitaxel
  • 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: June 12, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects who must meet all the following criteria should be selected:

  1. Agreeing to participate in this study and signing a written informed consent.
  2. Male or female,from 18 to 75 years (including 18 and 75 years).
  3. The life expectancy will be longer than 3 months and can be followed up.
  4. Patients with stage IIIB/IIIC/IV NSCLC were confirmed by histological /cytological and imaging examinations. According to RECIST 1.1 standard, there will be at least one measurable lesion.
  5. Initial medical treattment.Patients with adenocarcinoma need wild type of EGFR gene and ALK fusion gene negative to be included in this study.
  6. ECOG score will be 0 or 1 within 7 days before randomization.
  7. Within 14 days before the start of treatment, the results of laboratory test of blood routine, liver, kidney function and hormone levels must be met the following criteria:

    White blood cells: more than 3.0 × 109/L; Platelets: more than 100 × 109/L; Neutrophils: more than 1.5 × 109/L; Hemoglobin: more than 80g/L; Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN); Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN; Serum bilirubin: less than 1.25 × ULN; Serum creatinine: less than 1.25 × ULN. Cortisol and thyroid function will be in the normal range.

  8. The toxicity and side effects of previous chemotherapy will must be alleviated to grade 1 or below (except hair loss).
  9. Female subjects must take effective contraceptive measures throughout the study period; serum or urine pregnancy test results must be negative during screening and the whole study period.
  10. Male subjects should take effective contraceptive measures from the beginning of treatment to within 6 months after the end of treatment.

Exclusion Criteria:

Subjects who meet any of the following criteria could not participate in this study:

  1. Adenocarcinoma subjects with EGFR sensitive mutation or ALK translocation; molecular detection of EGFR-sensitive mutations or ALK translocations is not required in squamous carcinoma patients.
  2. NSCLC that had received chemotherapy in the past.
  3. Other malignant tumors needed treatment within five years.
  4. Allogeneic tissue/organ transplantation.
  5. Participating in research drug therapy within 4 weeks before the first administration of the trial.
  6. Systemic glucocorticoid therapy or any other form of immunosuppressive therapy (except glucocorticoid preconditioned with docetaxel) is being administered within 3 days before the first administration of the experimental therapy.
  7. Received anti-tumor monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy or major surgery within 4 weeks before the first use of the drug; received chest radiotherapy greater than 30 Gy within 6 months before the first use of the drug; and received chest radiotherapy with 30 Gy or less within 1 month before the first use of the drug.
  8. Previous treatment with PD-1/PD-L1 antibodies.
  9. Over the past two years, patients with active autoimmune diseases requiring systemic treatment, such as the use of corticosteroids, or immunosuppressants. Substitution therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction) is not a systemic treatment.
  10. Patients with congenital or acquired immunodeficiency (e.g. HIV-infected persons), active hepatitis B (HBV-DNA > 10^3 copies/ml) or hepatitis C (hepatitis C antibody positive), and HCV-RNA higher than the detection limit of the analytical method.
  11. Subjects with active central nervous system (CNS) metastases and/or cancerous meningitis.
  12. Patients with active infections requiring systemic intravenous therapy.
  13. Mental illness or other illnesses, such as uncontrollable heart disease or pulmonary disease, diabetes, etc.
  14. Subjects who are known to be allergic to any of the constituents of the drug being studied.
  15. Subjects with a recent history of drug abuse (including alcohol) within one year.
  16. Compliance is poor and can not cooperate with clinical research.
  17. Female subjects who are pregnant or breastfeeding, or who are expected to be pregnant during the trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Xiubao Ren, MD. PhD. 86-22-23340123 ext 3173 liangcoh@163.com
Contact: Liang Liu, MD. Ph.D 86-22-23340123 ext 3172 renxiubao@tjmuch.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03987867
Other Study ID Numbers  ICMJE E2019091A
Has Data Monitoring Committee Not Provided
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 Not Provided
Responsible Party Tianjin Medical University Cancer Institute and Hospital
Study Sponsor  ICMJE Tianjin Medical University Cancer Institute and Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Xiubao Ren, MD. PhD. Tianjin Medical University Cancer Institute and Hospital
PRS Account Tianjin Medical University Cancer Institute and Hospital
Verification Date July 2020

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