Comparing 3 approaches for non-small cell lung cancer
Official title: Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations
A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations (TROPION-Lung10)
- Phase 3
- 3 groups
- Sites in Chicoutimi, Vancouver and 11 more cities
- Recruiting
Interventions
- Medication
Datopotamab Deruxtecan
Datopotamab Deruxtecan IV (intravenous)
- Medication
Rilvegostomig
Rilvegostomig IV (intravenous)
- Medication
Pembrolizumab
Pembrolizumab IV (intravenous)
Canadian Sites (15)
12 of 15 recruiting
- Recruiting
Research Site
Vancouver, British Columbia
- Recruiting
Research Site
Chicoutimi
- Recruiting
Research Site
St. John's, Newfoundland and Labrador
- Recruiting
Research Site
London, Ontario
- Recruiting
Research Site
Oshawa, Ontario
- Recruiting
Research Site
Lévis, Quebec
- Recruiting
Research Site
Montreal, Quebec
- Recruiting
Research Site
Montreal, Quebec
- Recruiting
Research Site
Montreal, Quebec
- Recruiting
Research Site
Rimouski, Quebec
- Recruiting
Research Site
Trois-Rivières, Quebec
- Recruiting
Research Site
Saskatoon, Saskatchewan
- Withdrawn
Research Site
Winnipeg, Manitoba
- Withdrawn
Research Site
Newmarket, Ontario
- Withdrawn
Research Site
Toronto, Ontario
Eligibility Criteria
See who this study is looking for21 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and absence of documented local test result for any other known genomic alteration for which there are locally approved and available targeted first-line therapies.
- +Histologically or cytologically documented non-squamous NSCLC.
- +Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkersBiomarkerSomething measurable in the body used as a signal of what is happening.Read more →.
- +Known tumour PD-L1 expression status defined as TC ≥ 50%
- +At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baselineBaselineYour starting measurements, taken before treatment begins.Read more →
- +Adequate bone marrow reserve and organ function
- +ECOG performance status of 0 or 1
- +Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation.
Exclusion
- −Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants.
- −History of leptomeningeal carcinomatosis
- −Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled
- −Prior systemic therapy for advanced/metastatic NSCLC.
- −Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant.
- −History of another primary malignancy within 3 years
- −Active or prior documented autoimmune or inflammatory disorders (with exceptions)
- −Any evidence of severe or uncontrolled disease that makes it undesirable for the participant to participate in the study or that would jeopardies compliance with the protocolProtocolThe detailed plan a study must follow.Read more →.
- −Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage.
- −Has significant pulmonary function compromise, as determined by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →
- −Known clinically significant corneal disease
- −History of active primary immunodeficiency
- −History of any ILD/pneumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, has current or suspected ILD/pneumonitis that cannot be ruled out by imaging at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A receives Datopotamab Deruxtecan and Rilvegostomig.
Registry label: A: Arm 1: Datopotamab Deruxtecan in Combination With Rilvegostomig
Group B receives Rilvegostomig.
Registry label: B: Arm 2: Rilvegostomig Monotherapy
Group C, the comparison group, receives Pembrolizumab.
Registry label: C: Arm 3: Pembrolizumab Monotherapy
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 675 people.
The study is currently expected to finish around December 2029.
The main measurement is taken over: Approximately 4 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Progression-Free Survival (PFS) in TROP2 biomarkerBiomarkerSomething measurable in the body used as a signal of what is happening.Read more → positive participants — measured over Approximately 4 years.
Overall Survival (OS) in TROP2 biomarker positive participants — measured over Approximately 6 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06357533 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Datopotamab DeruxtecanDrug
Datopotamab Deruxtecan IV (intravenous)
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About RilvegostomigDrug
Rilvegostomig IV (intravenous)
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PembrolizumabDrug
Pembrolizumab IV (intravenous)
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Approximately 4 years.
The study as a whole is currently expected to finish around 2029-12-28.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 675 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 22 locations, including: Chicoutimi, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; St. John's, Newfoundland and Labrador, Canada; London, Ontario, Canada; Newmarket, Ontario, Canada, and 16 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.
Other Sites (9)
Research Site
Dearborn, Michigan, United States
Research Site
Farmington Hills, Michigan, United States
Research Site
Grand Rapids, Michigan, United States
Research Site
Traverse City, Michigan, United States
Research Site
Bozeman, Montana, United States
Research Site
Stony Brook, New York, United States
Research Site
Tacoma, Washington, United States
Research Site
Vancouver, Washington, United States
Research Site
Wenatchee, Washington, United States
Think this trial might be right for you?
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.