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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
No Placebo-Only Group
Pivotal Trial

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 below
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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.
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I have waited the required time after my last treatment before joining this trial.
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My lung cancer has worsened despite recent treatment.
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My lung cancer is at stage IIIB, IIIC, or IV.
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My blood, liver, and kidney tests are all within normal ranges.
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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:
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My NSCLC can be treated with local therapy only.
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I have fluid build-up that can't be regularly drained.
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My HIV infection is not well controlled.
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I do not have substance abuse issues or significant heart or mental health conditions.
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I do not have an infection needing IV treatment or one that can't be ruled out.
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I have or had lung inflammation that needed steroids, or it might be seen in my recent lung scans.
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I have been treated with a drug targeting topoisomerase I, TROP2, or received Docetaxel.
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My cancer has spread to the lining of my brain and spinal cord.
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I have severe lung problems due to another lung illness.
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I have an active hepatitis B or C infection that is not under control.
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My lung cancer is a mix of small-cell and non-small cell types.
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I have a serious eye condition affecting my cornea.
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I have a serious heart condition that is not under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until date of death due to any cause, up to approximately 43 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until date of death due to any cause, up to approximately 43 months for reporting.

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 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
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%
Headache
9%
Aspartate aminotransferase increased
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

Awards & Highlights

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.

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
418 Previous Clinical Trials
467,977 Total Patients Enrolled
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
422,330 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,411 Previous Clinical Trials
289,123,003 Total Patients Enrolled
Global Clinical LeaderStudy DirectorDaiichi Sankyo
163 Previous Clinical Trials
80,842 Total Patients Enrolled

Media Library

Docetaxel (Anti-microtubule agent) Clinical Trial Eligibility Overview. Trial Name: NCT04656652 — Phase 3
Lung Cancer Research Study Groups: DS-1062a 6.0 mg/kg, Docetaxel 75 mg/m^2
Lung Cancer Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT04656652 — Phase 3
Docetaxel (Anti-microtubule agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04656652 — Phase 3
~118 spots leftby Dec 2025
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