DS-1062a vs Docetaxel for Lung Cancer
Recruiting in Palo Alto (17 mi)
+208 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Daiichi Sankyo
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic alterations.
Eligibility Criteria
Adults over 18 with advanced or metastatic non-small cell lung cancer (NSCLC) who've had previous treatment can join. They must not be pregnant, agree to use birth control, and have a life expectancy of at least 3 months. People with certain heart conditions, adequate organ function, and no severe allergies to the drugs being tested are eligible.Inclusion Criteria
Sign and date the inform consent form (ICF) prior to the start of any study specific qualification procedures
I can provide a recent biopsy or have tissue samples from the last 2 years.
Your disease can be measured using a specific method called RECIST v1.1.
+14 more
Exclusion Criteria
You have had serious allergic reactions to the study drug DS-1062a, docetaxel, or other similar drugs in the past.
I do not have substance abuse issues or significant heart or mental health conditions.
My NSCLC can be treated with local therapy only.
+16 more
Participant Groups
The trial is testing DS-1062a against Docetaxel in patients with NSCLC who may also have specific genetic changes in their tumors. It will look at how well these treatments work, their safety profiles, and how the body processes them.
2Treatment groups
Experimental Treatment
Active Control
Group I: DS-1062a 6.0 mg/kgExperimental Treatment1 Intervention
Participants will be randomized to receive 6.0 mg/kg of DS-1062a.
Group II: Docetaxel 75 mg/m^2Active Control1 Intervention
Participants will be randomized to receive 75 mg/m\^2 docetaxel.
Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Taxotere for:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
🇪🇺 Approved in European Union as Taxotere for:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
🇨🇦 Approved in Canada as Taxotere for:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
🇯🇵 Approved in Japan as Taxotere for:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ft. Wayne Medical Oncology and HematologyFort Wayne, IN
Baton Rouge GeneralBaton Rouge, LA
University Health Network - Princess Margaret HospitalToronto, Canada
Cross Cancer InstituteEdmonton, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Daiichi SankyoLead Sponsor
Daiichi Sankyo, Inc.Lead Sponsor
AstraZenecaIndustry Sponsor