NCT02358473

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_1 nonsmall-cell-lung-cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2 years until next milestone

Results Posted

Study results publicly available

November 30, 2018

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.9 years

First QC Date

January 22, 2015

Results QC Date

October 10, 2017

Last Update Submit

September 4, 2024

Conditions

Non-Small Cell Lung Cancer

Keywords

Nonsmall Cell Lung CancerNSCLCNon-Small-Cell Lung CarcinomaCarcinoma, Non-Small Cell LungKW-0761Mogamulizumab

Outcome Measures

Primary Outcomes (3)

  • Number of Subjects Reporting Adverse Events

    Screening through 90 days after the last dose of study medication

  • Number of Subjects Reporting Serious Adverse Events

    Screening through 90 days after the last dose of study medication

  • Number of Subjects Experiencing Dose-limiting Toxicity

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

Secondary Outcomes (3)

  • Overall Response Rate

    One year

  • Progression Free Survival by RECIST 1.1

    One year

  • Overall Survival

    One year

Study Arms (1)

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.

Biological: mogamulizumabDrug: Docetaxel

Interventions

mogamulizumabBIOLOGICAL

Mogamulizumab will be administered by IV infusion.

Also known as: KW-0761, POTELIGEO®
mogamulizumab + docetaxel
DocetaxelDRUG

Docetaxel will be administered by IV infusion.

Also known as: Taxotere, Docecad, DTX
mogamulizumab + docetaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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;
  • +3 more criteria

You may not qualify if:

  • 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;
  • 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;
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Horizon Oncology

Lafayette, Indiana, 47905, United States

Location

John Hopkins University School of Medicine

Baltimore, Maryland, 21231, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

MD Anderson

Houston, Texas, 77025, United States

Location

Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

mogamulizumabDocetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title
Regional_Program Lead
Organization
Kyowa Kirin Pharmaceutical Development, Inc.
clinical.info@kyowa-kirin-pharma.com
1-609-919-1000

Study Officials

  • Michael Kurman

    Kyowa Kirin, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2015

First Posted

February 9, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 19, 2024

Results First Posted

November 30, 2018

Record last verified: 2024-09

Locations

US(5)