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Anti-microtubule agent
DS-1062a vs Docetaxel for Lung Cancer
Phase 3
Waitlist Available
Research Sponsored by Daiichi Sankyo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female participants must not donate, or retrieve for their own use, ova from the time of Screening and throughout the study period and for at least 7 months after the last dose of DS-1062a and for at least 6 months after the last dose of docetaxel
Adequate treatment washout period before randomization
Must not have
Has NSCLC disease that is eligible for definitive local therapy alone
Significant third-space fluid retention and is not amenable for required repeated drainage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until date of death due to any cause, up to approximately 43 months
Awards & highlights
Summary
This trial will compare the effectiveness of DS-1062a to the current standard of care drug, docetaxel, in treating lung cancer.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include reactions related to infusion of the drug into the bloodstream, issues affecting organs like the liver or kidneys due to drug toxicity, blood clotting problems, and possibly worsening of any current infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I will not donate or use my own eggs for 7 months after my last dose of DS-1062a and 6 months after the last dose of docetaxel.
Select...
I have waited the required time after my last treatment before joining this trial.
Select...
My lung cancer has worsened despite recent treatment.
Select...
My lung cancer is at stage IIIB, IIIC, or IV.
Select...
My blood, liver, and kidney tests are all within normal ranges.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My NSCLC can be treated with local therapy only.
Select...
I have fluid build-up that can't be regularly drained.
Select...
My HIV infection is not well controlled.
Select...
I do not have substance abuse issues or significant heart or mental health conditions.
Select...
I do not have an infection needing IV treatment or one that can't be ruled out.
Select...
I have or had lung inflammation that needed steroids, or it might be seen in my recent lung scans.
Select...
I have been treated with a drug targeting topoisomerase I, TROP2, or received Docetaxel.
Select...
My cancer has spread to the lining of my brain and spinal cord.
Select...
I have severe lung problems due to another lung illness.
Select...
I have an active hepatitis B or C infection that is not under control.
Select...
My lung cancer is a mix of small-cell and non-small cell types.
Select...
I have a serious eye condition affecting my cornea.
Select...
I have a serious heart condition that is not under control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization until date of death due to any cause, up to approximately 43 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until date of death due to any cause, up to approximately 43 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Survival (OS) Following DS-1062a Versus Docetaxel
Progression-free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1 Following DS-1062a Versus Docetaxel
Secondary study objectives
Disease Control Rate (DCR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
Duration of Response (DOR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
Objective Response Rate (ORR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
+5 moreSide effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Alanine aminotransferase increased
13%
Neurotoxicity
13%
Cough
13%
Vomting
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Headache
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
Trial Design
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.
Find a Location
Who is running the clinical trial?
Daiichi SankyoLead Sponsor
401 Previous Clinical Trials
446,470 Total Patients Enrolled
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
422,010 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,352 Previous Clinical Trials
288,646,219 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had serious allergic reactions to the study drug DS-1062a, docetaxel, or other similar drugs in the past.I can provide a recent biopsy or have tissue samples from the last 2 years.I do not have substance abuse issues or significant heart or mental health conditions.My NSCLC can be treated with local therapy only.Your disease can be measured using a specific method called RECIST v1.1.I have fluid build-up that can't be regularly drained.I am at least 18 years old or meet the legal age of consent in my area.My HIV infection is not well controlled.I have had cancer other than NSCLC, but it was treated and has been clear for over 3 years.I've had platinum chemotherapy and immunotherapy for Stage II lung cancer but haven't had treatments for Stage III or metastatic lung cancer.I do not have an infection needing IV treatment or one that can't be ruled out.I am a male either surgically sterile or will use a condom and my partner will use birth control.I am not pregnant and agree to use effective birth control during and up to 7 months after treatment.I agree not to donate or freeze sperm during and up to 6 months after treatment.I have or had lung inflammation that needed steroids, or it might be seen in my recent lung scans.I will not donate or use my own eggs for 7 months after my last dose of DS-1062a and 6 months after the last dose of docetaxel.I have been treated with a drug targeting topoisomerase I, TROP2, or received Docetaxel.I do not have active brain or spinal cord cancer that needs strong medication.I have waited the required time after my last treatment before joining this trial.My cancer has spread to the lining of my brain and spinal cord.I have severe lung problems due to another lung illness.I have an active hepatitis B or C infection that is not under control.My lung cancer has worsened despite recent treatment.My side effects from cancer treatment, except for hair loss, are mild or gone.You are expected to live for at least 3 more months.My lung cancer is at stage IIIB, IIIC, or IV.My lung cancer is a mix of small-cell and non-small cell types.My heart's pumping ability is normal, confirmed by a heart scan within the last month.I have a serious eye condition affecting my cornea.I have a serious heart condition that is not under control.My blood, liver, and kidney tests are all within normal ranges.Your blood clotting function is within a normal range.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: DS-1062a 6.0 mg/kg
- Group 2: Docetaxel 75 mg/m^2
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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