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Non-Small Cell Lung CancerPhase 1NCT02358473

Study of Mogamulizumab + Docetaxel in Subjects With Non-small Cell Lung Cancer

A Phase 1 study testing mogamulizumab and Docetaxel in people with Non-Small Cell Lung Cancer, run by Kyowa Kirin, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety of mogamulizumab in combination with docetaxel in adult subjects with previously treated locally advanced or metastatic non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
mogamulizumab and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
5 sitesUnited States
Study dates
Jan 2015to Dec 2016
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed Stage IIIB or IV advanced or metastatic NSCLC with measurable neoplastic disease. Sputum cytology alone is not considered an acceptable method of diagnosis;
  • Prior therapy must meet all of the following criteria:
  • Subject has experienced disease progression or unacceptable toxicity/intolerance after receiving at least 1 systemic platinum-containing regimen;
  • Subject with a tumor of non-squamous histology must be tested for epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) rearrangement. Subject with EGFR activating mutation or ALK rearrangement must have experienced disease progression or unacceptable toxicity/intolerance after receiving at least one EGFR tyrosine kinase inhibitor or ALK inhibitor;
  • Subject has received PD-1/PD-L1 blockade or has been informed of the results of relevant positive Phase 3 trials with these agents.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at baseline;
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  • Minimum life expectancy of 3 months;
  • Agrees to use a medically effective method of contraception. Male subjects and women of child-bearing potential (WOCBP) must agree to use effective contraception, e.g., oral contraceptives, double barrier method (condom plus spermicide or diaphragm plus spermicide), or practice true abstinence from sexual intercourse during the study and for 3 months after the last dose. Women of child-bearing potential include female subjects who have experienced menarche and have not undergone surgical sterilization or are not postmenopausal (defined as amenorrhea ≥ 12 consecutive months without an alternative medical cause);
  • WOCBP must have a negative serum pregnancy test within 7 days prior to receiving investigational product and a negative urine pregnancy test on Day 1 of each Cycle;
  • Recovered (i.e., Grade ≤ 1 or to a baseline level) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other therapies for cancer (with the exception of alopecia for which no resolution is required and peripheral neuropathy which must have resolved to Grade ≤ 1 for subjects receiving prior taxane-based chemotherapy);
  • Adequate organ function defined as below:
  • Total bilirubin ≤ upper limit of normal (ULN);
  • Hemoglobin (Hgb) ≥ 9.0 g/dL;
  • Serum creatinine (sCr) ≤ 1.5 x ULN;
  • Absolute neutrophil count (ANC) ≥ 1500 cells/mm3;
  • Platelets ≥ 100 × 109/L;
  • Sufficient archived tumor samples (if taken within 6 months prior to treatment may be submitted) available for PD assessments, or willingness to undergo a pre-treatment core needle biopsy, preferably of the primary tumor, in order to obtain such tissue;
  • Willing and able to undergo a post-dose core needle biopsy.

Who cannot join

  • Prior treatment with docetaxel or mogamulizumab;
  • Requires administration of a prohibited medication or treatment;
  • Has a significant uncontrolled intercurrent illness including, but not limited to:
  • Ongoing or active infection requiring antibiotics;
  • Clinically significant cardiac disease (class III, or IV of the New York Heart Association classification; unstable angina pectoris, myocardial infarction within 6 months or is post angioplasty or stenting within 6 months; clinically significant cardiac arrhythmia, or uncontrolled hypertension (i.e., systolic blood pressure > 150 mm Hg, diastolic blood pressure > 90 mmHg) despite anti-hypertensive medication;
  • Uncontrolled diabetes, active liver disease, poorly controlled chronic obstructive pulmonary disease, serious or non-healing wound, ulcer, or fracture;
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  • Known or tests positive for human immunodeficiency virus, hepatitis B, or hepatitis C
  • Active known auto-immune disease with the exception of autoimmune thyroiditis, vitiligo, and alopecia;
  • Pleural effusion requiring repetitive drainage, i.e., an indwelling catheter or 2 thoracenteses with 6 weeks of the first dose of mogamulizumab;
  • Received monoclonal antibodies (for any reason), chemotherapy, surgery, investigational therapy, or radiotherapy within 14 days of the first dose of mogamulizumab;
  • Received live, attenuated vaccine within 28 days prior to the first dose of mogamulizumab;
  • Use of immunosuppressive medication within 14 days before the first dose of mogamulizumab. Note: Inhaled, intranasal, intra-articular, or topical corticosteroids are allowed. Non-immunosuppresive doses of systemic steroids for adrenal replacement or for contrast allergy are allowed;;
  • Any history or signs of central nervous system metastases;
  • Any history or signs of pulmonary lymphangitic spread;
  • Experienced a Grade 3 or higher hypersensitivity reaction to monoclonal antibodies or other therapeutic proteins, and the reaction could not be controlled or prevented on subsequent infusion with standard therapies such as antihistamines, 5-hydroxytryptamine (5-HT3) receptor antagonists, or corticosteroids;
  • The subject has a history of severe hypersensitivity reactions to drugs formulated with polysorbate 80;
  • History of second primary cancer within the past 5 years, with the exception of:
  • Curatively resected non-melanomatous skin cancer;
  • Curatively treated cervical intraepithelial neoplasia or prostate carcinoma with current prostate specific antigen (PSA) < 0.01 ng/mL; or
  • Curatively treated ductal carcinoma in situ of the breast;
  • The subject is pregnant or breastfeeding.
  • The subject has aspartate aminotransferase and/or alanine aminotransferase > 1.5 × ULN, with concomitant alkaline phosphatase > 2.5 × ULN.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • John Hopkins University School of Medicine

    Baltimore, Maryland, 21231

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • MD Anderson

    Houston, Texas, 77025

  • Horizon Oncology

    Lafayette, Indiana, 47905

  • Cancer Therapy and Research Center

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: Open-label, Multicenter Phase 1 Study of Mogamulizumab (KW-0761) in Combination With Docetaxel in Previously Treated Subjects With Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to evaluate the safety of mogamulizumab in combination with docetaxel in adult subjects with previously treated locally advanced or metastatic non-small cell lung cancer.

Being tested
mogamulizumab, Docetaxel
Keywords
Nonsmall Cell Lung Cancer, NSCLC, Non-Small-Cell Lung Carcinoma, Carcinoma, Non-Small Cell Lung, KW-0761, Mogamulizumab
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.

  • mogamulizumabBiological

    Also called KW-0761, POTELIGEO®

    Mogamulizumab will be administered by IV infusion.

  • DocetaxelDrug

    Also called Taxotere, Docecad, DTX

    Docetaxel will be administered by IV infusion.

Study groups in NCT02358473
Study groupRoleWhat they receive
mogamulizumab + docetaxelExperimentalMogamulizumab will be given as monotherapy in a 4-week run-in period. Subjects will then receive up to 6 cycles of mogamulizumab in combination with docetaxel at appropriate intervals. Subjects may then continue to receive mogamulizumab, at the same dose administered in Cycle 1, once every 3 weeks as monotherapy.
Receives: Biological: mogamulizumab; Drug: Docetaxel

What is being measured

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

  1. Number of Subjects Reporting Adverse Events

    Measured: Screening through 90 days after the last dose of study medication

  2. Number of Subjects Reporting Serious Adverse Events

    Measured: Screening through 90 days after the last dose of study medication

  3. Number of Subjects Experiencing Dose-limiting Toxicity

    Measured: First dose of study medications through 4 weeks after the last dose of study medication

Secondary outcomes (3)

  1. Overall Response Rate

    The anti-tumor effect based on the Response Evaluation Criteria in Solid Tumors (RECIST version1.1), as well as by the immune-related RECIST (irRECIST).

    Measured: One year

  2. Progression Free Survival by RECIST 1.1

    The anti-tumor effect based on the Response Evaluation Criteria in Solid Tumors (RECIST version1.1), as well as by the immune-related RECIST (irRECIST).

    Measured: One year

  3. Overall Survival

    The anti-tumor effect based on the Response Evaluation Criteria in Solid Tumors (RECIST version1.1), as well as by the immune-related RECIST (irRECIST).

    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 posted9 Feb 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionDec 2016
  4. Study completionDec 2016

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
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02358473
Sponsor's protocol ID
0761-011
Status last verified
Sep 2024
First submitted
22 Jan 2015
Last updated
19 Sep 2024
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing mogamulizumab and Docetaxel in people with Non-Small Cell Lung Cancer, run by Kyowa Kirin, Inc. at 5 sites in United States.

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 18 inclusion and 22 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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?

Yes. Results are posted in the registry (first posted 30 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Subjects Reporting Adverse Events (time frame: Screening through 90 days after the last dose of study medication). The study lists 3 primary outcomes in all. 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 NCT02358473.

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 19 Sep 2024.

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