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AzTrials

Non-small Cell Lung CancerPhase 1NCT03987867

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

A Phase 1 study testing CIK cell, Sintilimab Injection and Pemetrexed in people with Non-small Cell Lung Cancer and First-line Treatment, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
CIK cell, Sintilimab Injection and Pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Jun 2019to 1 Jun 2021
Phase
Phase 1
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects who must meet all the following criteria should be selected:
  • Agreeing to participate in this study and signing a written informed consent.
  • Male or female,from 18 to 75 years (including 18 and 75 years).
  • The life expectancy will be longer than 3 months and can be followed up.
  • 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.
  • Initial medical treattment.Patients with adenocarcinoma need wild type of EGFR gene and ALK fusion gene negative to be included in this study.
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  • ECOG score will be 0 or 1 within 7 days before randomization.
  • 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.
  • The toxicity and side effects of previous chemotherapy will must be alleviated to grade 1 or below (except hair loss).
  • 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.
  • Male subjects should take effective contraceptive measures from the beginning of treatment to within 6 months after the end of treatment.

Who cannot join

  • Subjects who meet any of the following criteria could not participate in this study:
  • 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.
  • NSCLC that had received chemotherapy in the past.
  • Other malignant tumors needed treatment within five years.
  • Allogeneic tissue/organ transplantation.
  • Participating in research drug therapy within 4 weeks before the first administration of the trial.
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  • 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.
  • 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.
  • Previous treatment with PD-1/PD-L1 antibodies.
  • 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.
  • 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.
  • Subjects with active central nervous system (CNS) metastases and/or cancerous meningitis.
  • Patients with active infections requiring systemic intravenous therapy.
  • Mental illness or other illnesses, such as uncontrollable heart disease or pulmonary disease, diabetes, etc.
  • Subjects who are known to be allergic to any of the constituents of the drug being studied.
  • Subjects with a recent history of drug abuse (including alcohol) within one year.
  • Compliance is poor and can not cooperate with clinical research.
  • Female subjects who are pregnant or breastfeeding, or who are expected to be pregnant during the trial.

Trial locations and contacts

1 site in 1 country.

Xiubao Ren, MD. PhD. contact

86-22-23340123 ext. 3173

liangcoh@163.com

Liang Liu, MD. Ph.D contact

86-22-23340123 ext. 3172

renxiubao@tjmuch.com

China1 site, 1 recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

    Liang Liu, MD. Ph.D, 86-22-23340123 ext. 3172, liangcoh@163.com

    Xiubao Ren, MD. PhD., 86-22-23340123 ext. 3173, renxiubao@tjmuch.com

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Read the 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.

Being tested
CIK cell, Sintilimab Injection, Pemetrexed, Liposome paclitaxel, Carboplatin
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CIK cellBiological

    Also called Autologous cytokine-induced killer cells

    CIK cell injection

  • Sintilimab InjectionBiological

    Also called PD-1 inhibitor

    IBI308 injection

  • PemetrexedDrug

    Pemetrexed injection

  • Liposome paclitaxelDrug

    Liposome paclitaxel injection

  • CarboplatinDrug

    Carboplatin injection

Study groups in NCT03987867
Study groupRoleWhat they receive
Arm: CIK+PD-1 inhibitor+chemotherapyExperimentalCIK 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.
Receives: Biological: CIK cell; Biological: Sintilimab Injection; Drug: Pemetrexed; Drug: Liposome paclitaxel; Drug: Carboplatin

What is being measured

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

  1. Objective response rate (ORR)

    ORR was calculated by the percentage of patients with a confirmed complete (CR) or partial response (PR).

    Measured: 2 years

Timeline

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

  1. First posted17 Jun 2019
  2. Study start1 Jun 2019
  3. Primary completion1 Jun 2021 (estimated)
  4. Study completion1 Jun 2021 (estimated)

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03987867
Sponsor's protocol ID
E2019091A
Status last verified
Jul 2020
First submitted
12 Jun 2019
Last updated
7 Jul 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhou L, Xiong Y, Wang Y, Meng Y, Zhang W, Shen M, Zhang X, Li S, Ren B, Li R, Han Y, Zhang J, Cao S, Du W, Sun Q, Wei F, An X, Yang L, Zhang Y, Ma W, Xu W, Zhang Y, Jiang J, Xu X, Xia J, Liu L, Ren X. A Phase IB Trial of Autologous Cytokine-Induced Killer Cells in Combination with Sintilimab, Monoclonal Antibody Against Programmed Cell Death-1, plus Chemotherapy in Patients with Advanced Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2022 Dec;23(8):709-719. doi: 10.1016/j.cllc.2022.07.009. Epub 2022 Jul 21.

    PubMed 35995696

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CIK cell, Sintilimab Injection and Pemetrexed in people with Non-small Cell Lung Cancer and First-line Treatment, run by Tianjin Medical University Cancer Institute and Hospital 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 12 inclusion and 18 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 7 Jul 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Contact Xiubao Ren, MD. PhD. (86-22-23340123 ext. 3173, liangcoh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: 2 years). 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 NCT03987867, 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 7 Jul 2020.

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