Comparing 3 approaches for non-small cell lung cancer
Official title: A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)
An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)
- Phase 2
- 3 groups
- One site, in Toronto
- Recruiting
Interventions
- Medication
Rilvegostomig
Rilvegostomig will be administered as IV infusion.
- Medication
Ramucirumab
Ramucirumab will be administered as IV infusion.
- Medication
Dato-DXd
Dato-DXd will be administered as IV infusion.
Canadian Sites (1)
1 listed, none recruiting
- Not yet recruiting
Research Site
Toronto, Ontario
Eligibility Criteria
See who this study is looking for42 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +PD-L1 TC ≥ 1% (TC≥ 50% for sub-study 1, 1-49% for sub-study 2)
- +Absence of sensitizing EGFR mutations or ALK rearrangements. No known other Actionable Genomic Alterations(AGAs)
- +Spinal cord compression or leptomeningeal carcinomatosis for sub-study 1 and sub-study 2. Unstable spinal cord compression for sub-study 3
- +Unstable brain metastases
- +Active infection, including TB and infections with HIV, HBV (verified by known positive HBsAg result), HCV.
- +for All Sub-studies:
- +Participant must be ≥ 18 years of age at the time of signing the ICFInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +At least 1 lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baselineBaselineYour starting measurements, taken before treatment begins.Read more →.
- +Adequate bone marrow and organ function
- +Life expectancy ≥ 12 weeks
- +Provision of acceptable tumour tissue
- +Specific Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → for Sub-Study 1 and Sub-Study 2:
- +Histologically or cytologically documented advanced or metastatic NSCLC
- +Specific Inclusion Criteria for Sub-Study 3:
- +Histologically or cytologically documented advanced or metastatic non-squamous NSCLC
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → for All Sub-studies:
- +As judged by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, any severe or uncontrolled systemic diseases, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocolProtocolThe detailed plan a study must follow.Read more →
- +Active or prior documented autoimmune or inflammatory disorders
- +Persistent toxicities (CTCAE Grade ≥ 2) (NCI CTCAE v5.0) caused by previous anti cancer therapy, excluding alopecia.
- +History of another primary malignancy.
- +Uncontrolled or significant cardiac disease
- +Prior exposure to immune-mediated therapy
- +History of uncontrolled hypertension, and active bleeding diseases, and high risks of bleeding and disorders of coagulation
- +Any concurrent anti-cancer treatment.
- +Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention.
- +WHO/ECOG performance status of 0 or 1
- +Documented positive AGA and had progressed on prior targeted therapy
- +Receipt of prior systemic chemotherapy/chemoradiation/immunotherapy for advanced NSCLC for sub-study 1 and sub-study 2.
Exclusion
- −Spinal cord compression or leptomeningeal carcinomatosis for sub-study 1 and sub-study 2. Unstable spinal cord compression for sub-study 3
- −Unstable brain metastases
- −Active infection, including TB and infections with HIV, HBV (verified by known positive HBsAg result), HCV.
- −for All Sub-studies:
- −As judged by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, any severe or uncontrolled systemic diseases, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocolProtocolThe detailed plan a study must follow.Read more →
- −Active or prior documented autoimmune or inflammatory disorders
- −Persistent toxicities (CTCAE Grade ≥ 2) (NCI CTCAE v5.0) caused by previous anti cancer therapy, excluding alopecia.
- −History of another primary malignancy.
- −Uncontrolled or significant cardiac disease
- −Prior exposure to immune-mediated therapy
- −History of uncontrolled hypertension, and active bleeding diseases, and high risks of bleeding and disorders of coagulation
- −Any concurrent anti-cancer treatment.
- −Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention.
- −Receipt of prior systemic chemotherapy/chemoradiation/immunotherapy for advanced NSCLC for sub-study 1 and sub-study 2.
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 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Groups A and B receive Rilvegostomig and Ramucirumab.
Registry label: A: Sub-study 1, investigate rilvegostomig± ramucirumab in 1L non-AGA NSCLC with PD-L1 ≥50% · B: Sub-study 2, investigate rilvegostomig + ramucirumab in 1L non-AGA NSCLC with PD-L1 1-49%
Group C receives Dato-DXd, Ramucirumab and Rilvegostomig.
Registry label: C: Sub-study 3, investigate Dato-DXd + ramucirumab ± rilvegostomig in 2/3L AGA+ NSCLC
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
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.
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 278 people.
The study is currently expected to finish around April 2029.
The main measurement is taken over: Through study completion, an average of 3 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Number of participants with adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AE) and serious adverse eventsSerious adverse eventAn adverse event meeting a formal severity threshold, such as requiring hospital admission.Read more → (SAE) — measured over Through study completion, an average of 3 years.
Objective response rate (ORR) — measured over Through study completion, an average of 3 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07098338 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 RilvegostomigDrug
Rilvegostomig will be administered as IV infusion.
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 RamucirumabDrug
Ramucirumab will be administered as IV infusion.
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 Dato-DXdDrug
Dato-DXd will be administered as IV infusion.
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.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
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: Through study completion, an average of 3 years.
The study as a whole is currently expected to finish around 2029-04-06.
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 278 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This is a Phase II, multi-center, open-label platform study evaluating novel combination treatment options in participants with locally advanced or metastatic NSCLC. The study will consist of several sub-studies, each evaluating the safety, tolerability, and preliminary antitumour activity of various treatment combinations. This study will be conducted in approximately 80 centers globally across 10 countries.
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Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
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.