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.
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
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.
- Conditions
- 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 group | Role | What they receive |
|---|---|---|
| mogamulizumab + docetaxel | Experimental | Mogamulizumab 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.
Number of Subjects Reporting Adverse Events
Measured: Screening through 90 days after the last dose of study medication
Number of Subjects Reporting Serious Adverse Events
Measured: Screening through 90 days after the last dose of study medication
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)
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
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
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.
- First posted9 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Kurman, Study director, Kyowa Kirin, Inc.
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02358473
- Acronym / sponsor ID
- 0761-011
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Nonsmall Cell Lung Cancer, NSCLC, Non-Small-Cell Lung Carcinoma, Carcinoma, Non-Small Cell Lung, KW-0761, Mogamulizumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Kyowa Kirin, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Feb 2015 (estimated)
- Results
- Posted 30 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mogamulizumab + docetaxel | Experimental | Biological: mogamulizumab, Drug: DocetaxelMogamulizumab 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at baseline;
- 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);
Key exclusion criteria (22 listed)
- 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:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mogamulizumabAlso: KW-0761, POTELIGEO®Mogamulizumab will be administered by IV infusion. | Biological | mogamulizumab + docetaxel |
| DocetaxelAlso: Taxotere, Docecad, DTXDocetaxel will be administered by IV infusion. | Drug | mogamulizumab + docetaxel |
Primary outcome
Number of Subjects Reporting Adverse Events
Time frame: Screening through 90 days after the last dose of study medication
Number of Subjects Reporting Serious Adverse Events
Time frame: Screening through 90 days after the last dose of study medication
Number of Subjects Experiencing Dose-limiting Toxicity
Time frame: First dose of study medications through 4 weeks after the last dose of study medication
3 secondary outcomes
Overall Response Rate
Time frame: One year
Progression Free Survival by RECIST 1.1
Time frame: One year
Overall Survival
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kurman study director
Kyowa Kirin, Inc.
5 sites in 1 country: see every site and its status.
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?
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; AzTrials last refreshed its copy on 8 Nov 2026.