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Antisense Oligonucleotide

Custirsen + Docetaxel for Non-Small Cell Lung Cancer

Phase 3
Waitlist Available
Research Sponsored by Achieve Life Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

The primary objective of the study is to compare overall survival of patients randomized to receiving custirsen in combination with docetaxel (Arm A) with patients randomized to receive docetaxel alone (Arm B).

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 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
Secondary study objectives
Adverse events
Disease Control Rate
Duration of Disease Control
+3 more

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
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: Custirsen + DocetaxelExperimental Treatment2 Interventions
Custirsen: Three loading doses of custirsen 640mg IV over 2 hours administered in 5 to 9 days prior to Day 1 of Cycle 1, then custirsen 640 mg IV weekly every 21-day cycle Docetaxel: 75 mg/m2 IV over 1 hour on Day 1 of every 21-day cycle
Group II: DocetaxelActive Control1 Intervention
Docetaxel: 75 mg/m2 IV over 1 hour on Day 1 of every 21-day cycle Continue treatment until disease progression, unacceptable toxicity, withdrawal of consent or protocol specified parameters to stop treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Custirsen
Not yet FDA approved
Docetaxel
FDA approved

Find a Location

Who is running the clinical trial?

Achieve Life SciencesLead Sponsor
35 Previous Clinical Trials
7,068 Total Patients Enrolled
~53 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
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