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Lung AdenocarcinomaPhase 2NCT02621333

Chemotherapy Combined Autologous Cytokine-induced Killer Cells in Naive Stage IV EGFR-wild Type Lung Adenocarcinoma

A Phase 2 study testing CIK and chemotherapy in people with Lung Adenocarcinoma, run by Henan Cancer Hospital at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a prospective, randomized, open, multicenter phase Ⅱ study to evaluate the efficacy of cytokine-induced killer cells combined chemotherapy in stage Ⅳ naive EGFR wild-type lung adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lung Adenocarcinoma
What is being tested?
CIK and chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
1 siteChina
Study dates
Oct 2015to Sep 2018
Phase
Phase 2
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed as stage Ⅳ naive EGFR wild-type lung adenocarcinoma by image, tissue and/or cytology; or relapse after operation (if the patient received adjuvant chemotherapy and the interval between the last chemotherapy and relapse is at least six months. The detection method of EGFR mutation is ARMS.
  • EML4-ALK fuse gene is negative and the detection of EML4-ALK is FISH or ventana IHC.
  • There should be at least one measurable lesions (by CT or MRI)
  • No other cancer history ( except skin squamous cell carcinoma after surgery)
  • Age between 18 and 75 years old
  • World health organization- Eastern Cooperative Oncology Group Performance Status 0-1
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  • Life expectancy more than 3 months and can be followed-up
  • Patients must have adequate organ and marrow functions as defined below: white blood cells: more than 3.5×109/L, Neutrophils: more than 1.5×109/L, Platelets: more than 80×109/L, Hemoglobin more than 90g/L, Serum total bilirubin less than 1.5 folds of the upper normal limit (ULN), Serum glutamic-oxal
  • acetic transaminase: less than 2.5×ULN (if there is liver metastasis less than 5×ULN); Serum creatinine: less than 1.0×ULN, Prothrombin time, Active partial thromboplastin time, Fibrinogen, Thrombin time are in normal ranges.
  • Women of child-bearing period must take effective contraceptive measures during all the time of study. During the period of study the results of blood and urine pregnancy test should be negative.
  • Men should take effective contraceptive measures from the beginning of therapy to one month after the last cycle of chemotherapy.
  • Willing to comply with the ban and constraints for this study protocol specified.
  • Informed consent and willing to participate in this study.

Who cannot join

  • Accepted other study drugs 30 days before the beginning of this study.
  • Brain metastases with clinical symptoms ( with exception of being controlled after radiation)
  • Active viral or bacterial infection and can't be controlled with appropriate anti-infection treatment
  • Known as HIV infection, syphilis serology reaction positive, active hepatitis B virus or hepatitis C virus infection
  • Suffering from mental illness or other illness, such as heart or lung disease, diabetes, etc. that can not be controlled, and can not be coped with study treatment and monitoring requirements.
  • Known allergy to any kind of component of study drugs
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  • Active rheumatic diseases
  • Organ transplant recipients
  • Poor compliance
  • Pregnant women
  • Lactating women

Trial locations and contacts

1 site in 1 country.

China1 site

  • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official title: Chemotherapy Combined Autologous Cytokine-induced Killer Cells in Naive Stage IV EGFR-wild Type Lung Adenocarcinoma: A Prospective, Randomised, Open, Multicenter Phase Ⅱ Study

This is a prospective, randomized, open, multicenter phase Ⅱ study to evaluate the efficacy of cytokine-induced killer cells combined chemotherapy in stage Ⅳ naive EGFR wild-type lung adenocarcinoma.

Read the detailed description

There is still no great improvement in advanced EGFR wild-type lung adenocarcinoma although great progress was made in treatment of non-small cell lung cancer. It's necessary to explore the treatment mode of this kind of patients. As the progress was made in tumor immunity and immunotherapy, more and more cancer therapists accept the treatment model of chemotherapy combined immunotherapy. And now chemotherapy combined autologous CIK cells is one kind of common treatment model in some countries. Investigators try to evaluate the efficacy and safety of this kind of treatment model in patients with stage Ⅳ naive EGFR wild-type lung adenocarcinoma.

Being tested
CIK, chemotherapy
Medical subject headings
Adenocarcinoma of Lung

What participants receive

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

  • CIKBiological

    Also called autologous cytokine-induced killer cells

    platinum combined doublets: Paclitaxel 175mg/m2 D1, or Docetaxel75mg/m2 D1, or Pemetrexed Disodium 500mg/m2，D1；combined cisplatin 25mg/m2，D1-3 or carboplatin AUC=5, D1. After 3 or 4 days of chemotherapy, about 5×109 autologous cytokine-induced killer cells are transfused into the vein of patients in one hour.

  • chemotherapyDrug

    Also called platinum combined doublets

    platinum combined doublets: Paclitaxel 175mg/m2 D1, or Docetaxel75mg/m2 D1, or Pemetrexed Disodium 500mg/m2，D1；combined cisplatin 25mg/m2，D1-3 or carboplatin AUC=5, D1.

Study groups in NCT02621333
Study groupRoleWhat they receive
CIK combined chemotherapy groupExperimentalautologous CIK combined chemotherapy group Drugs: platinum combined doublets; After 3 or 4 days of chemotherapy, about 5×109 autologous cytokine-indued killer cells are transfused into the vein of patients in one hour.
Receives: Biological: CIK; Drug: chemotherapy
chemotherapy groupActive comparatorplatinum combined doublets Drugs: Paclitaxel 175mg/m2 D1, or Docetaxel75mg/m2 D1, or Pemetrexed Disodium 500mg/m2，D1；combined cisplatin 25mg/ m2，D1-3 or carboplatin AUC=5, D1.
Receives: Drug: chemotherapy

What is being measured

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

  1. overall survival time

    overall survival time aims at from date of randomization until the date of death from any cause, up to 36 months

    Measured: from the day of randomization to the day of death, up to 36 months

Secondary outcomes (2)

  1. time to progression

    time to progression points to from date of randomization until the date of first documented progression, up to 24 months

    Measured: from the day of randomization to the day of first detecting progression, up to 24 months

  2. objective response rate

    the partion of overall remission in total proportion

    Measured: one year

Timeline

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

  1. First posted3 Dec 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionSep 2018
  4. Study completionSep 2018

Why it stopped: As there are so many clinical trials in progress and the number of patients enrolled limited.

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02621333
Sponsor's protocol ID
HenanCH003
Status last verified
Feb 2020
First submitted
25 Nov 2015
Last updated
12 May 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No: terminated as the slow enrollment

Publications

  • Li R, Wang C, Liu L, Du C, Cao S, Yu J, Wang SE, Hao X, Ren X, Li H. Autologous cytokine-induced killer cell immunotherapy in lung cancer: a phase II clinical study. Cancer Immunol Immunother. 2012 Nov;61(11):2125-33. doi: 10.1007/s00262-012-1260-2. Epub 2012 May 13.

    PubMed 22581306

  • Zhong R, Teng J, Han B, Zhong H. Dendritic cells combining with cytokine-induced killer cells synergize chemotherapy in patients with late-stage non-small cell lung cancer. Cancer Immunol Immunother. 2011 Oct;60(10):1497-502. doi: 10.1007/s00262-011-1060-0. Epub 2011 Jun 17.

    PubMed 21681372

  • Wang S, Wang Z. Efficacy and safety of dendritic cells co-cultured with cytokine-induced killer cells immunotherapy for non-small-cell lung cancer. Int Immunopharmacol. 2015 Sep;28(1):22-8. doi: 10.1016/j.intimp.2015.05.021. Epub 2015 May 23.

    PubMed 26013109

  • Zhao L, Li W, Wang Z, Yang Y, Zhang Y, Shang Y, Ren X, Gao Q. Survival benefit from RectroNectin-activated cytokine-induced killer cells combined with chemotherapy in advanced EGFR wild-type lung adenocarcinoma. Immunotherapy. 2018 Mar 1;10(6):501-510. doi: 10.2217/imt-2017-0140.

    PubMed 29562855

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CIK and chemotherapy in people with Lung Adenocarcinoma, run by Henan Cancer 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 13 inclusion and 11 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: stopped early, as of the sponsor's last update on 12 May 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: As there are so many clinical trials in progress and the number of patients enrolled limited.). Results are not available in the source record.

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?

overall survival time (time frame: from the day of randomization to the day of death, up to 36 months). 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 NCT02621333, which also lists 4 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 12 May 2021.

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