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Tyrosine Kinase Inhibitor
Osimertinib + Datopotamab Deruxtecan for Lung Cancer (TROPION-Lung14 Trial)
Changchun, China
Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically documented nonsquamous NSCLC.
Participants must not have received prior EGFR TKIs or other systemic therapy for Stage IIIB, IIIC or IV NSCLC.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up it is anticipated that it will be performed approximately 3 years after the first participant is randomised.
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will test whether a combination of osimertinib (tablet) and Datopotamab Deruxtecan (i.v. infusion) is more effective and safe than using osim
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Who is the study for?
This trial is for adults with advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) that has specific EGFR mutations. Participants must not have had prior treatments for this stage of cancer and should be in good physical condition (WHO performance status of 0 or 1). A tissue sample confirming the mutation is required.Check my eligibility
What is being tested?
The study compares the effectiveness and safety of osimertinib alone versus combined with Datopotamab Deruxtecan as a first-line treatment. Patients will receive these treatments over an estimated period of nine years until disease progression, unacceptable side effects, or other criteria lead to discontinuation.See study design
What are the potential side effects?
Potential side effects may include reactions related to osimertinib tablets and Datopotamab Deruxtecan infusions such as fatigue, digestive issues, skin reactions, blood clots, shortness of breath, and possible infusion-related symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is non-squamous based on tissue analysis.
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I have not taken any drugs for advanced lung cancer before.
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My tumor has EGFR mutations linked to treatment response.
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I can provide a sample of my tumor for EGFR mutation testing.
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I am fully active or able to carry out light work.
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My lung cancer is at an advanced stage and cannot be cured with surgery or chemoradiation.
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I have a tumor that can be measured and has not been treated with radiation.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ it is anticipated that it will be performed approximately 3 years after the first participant is randomised.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~it is anticipated that it will be performed approximately 3 years after the first participant is randomised.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To demonstrate the superiority of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS by BICR in all randomised participants.
Secondary study objectives
To assess the PK of osimertinib and Datopotamab Deruxtecan
To compare the local EGFR mutation test result used for patient selection with the retrospective central cobas® EGFR Mutation Test v2 results from baseline tumour samples
To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of DoR in all randomised participants with measurable disease at baseline.
+8 moreAwards & 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: Arm 1: Osimertinib in combination with Datopotamab DeruxtecanExperimental Treatment2 Interventions
Participants in this group will receive osimertinib 80 mg QD as oral tablet with Datopotamab Deruxtecan 6mg/kg as i.v. infusion q3w of Day 1 of every 21-day cycle.
Group II: Arm 2: Osimertinib monotherapyActive Control1 Intervention
Participants in this group will receive osimertinib 80 mg QD as oral tablet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 2
~1210
Find a Location
Closest Location:Research Site· Montreal, Canada
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,485 Previous Clinical Trials
290,541,092 Total Patients Enrolled
Daiichi SankyoIndustry Sponsor
441 Previous Clinical Trials
491,594 Total Patients Enrolled