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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07098338
Registration number
NCT07098338
Ethics application status
Date submitted
4/07/2025
Date registered
1/08/2025
Date last updated
1/08/2025
Titles & IDs
Public title
A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)
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Scientific title
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)
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Secondary ID [1]
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D6187C00001
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Universal Trial Number (UTN)
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Trial acronym
LIBRA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rilvegostomig
Treatment: Drugs - Ramucirumab
Treatment: Drugs - Dato-DXd
Experimental: Sub-study 1, investigate rilvegostomig± ramucirumab in 1L non-AGA NSCLC with PD-L1 =50% - Participants will receive rilvegostomig ± ramucirumab until RECIST 1.1-defined radiological progression as assessed by the investigator, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion
Experimental: Sub-study 2, investigate rilvegostomig + ramucirumab in 1L non-AGA NSCLC with PD-L1 1-49% - Participants will receive rilvegostomig + ramucirumab until RECIST 1.1-defined radiological progression as assessed by the investigator, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion
Experimental: Sub-study 3, investigate Dato-DXd + ramucirumab ± rilvegostomig in 2L AGA+ NSCLC - Participants will receive Dato-DXd + ramucirumab ± rilvegostomig until RECIST 1.1-defined radiological progression as assessed by the investigator, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion
Treatment: Drugs: Rilvegostomig
Rilvegostomig will be administered as IV infusion.
Treatment: Drugs: Ramucirumab
Ramucirumab will be administered as IV infusion.
Treatment: Drugs: Dato-DXd
Dato-DXd will be administered as IV infusion.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with adverse events (AE) and serious adverse events (SAE)
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Assessment method [1]
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To assess the safety and tolerability
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Timepoint [1]
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Through study completion, an average of 3 years
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Primary outcome [2]
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Objective response rate (ORR)
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Assessment method [2]
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ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response), determined by the Investigator at local site per RECIST 1.1
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Timepoint [2]
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Through study completion, an average of 3 years
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Secondary outcome [1]
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Best Overall Response(BOR)
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Assessment method [1]
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BOR is the best response a participant has had following randomisation/start of dosing, but prior to starting any subsequent cancer therapy and up to and including RECIST progression or the last evaluable assessment in the absence of RECIST progression
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Timepoint [1]
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Through study completion, an average of 3 years
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Secondary outcome [2]
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Change in Target Lesion Tumor Size
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Assessment method [2]
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The best percentage change from baseline in Target Lesion tumour size is the largest decrease (or smallest increase) from baseline for a participant, using RECIST 1.1 assessments
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Timepoint [2]
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Through study completion, an average of 3 years
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Secondary outcome [3]
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Progression free survival (PFS)
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Assessment method [3]
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PFS is defined as the time from the start of treatment until the date of objective disease progression or death (by any cause in the absence of progression) per RECIST 1.1 as assessed by Investigator.
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Timepoint [3]
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Through study completion, an average of 3 years
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Secondary outcome [4]
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Disease Control Rate(DCR) at 12 Weeks
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Assessment method [4]
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DCR at 12 weeks is defined as the percentage of participants who have a best objective response of confirmed CR or PR or who have SD for at least 11 weeks after start of treatment (to allow for an early assessment within the assessment window).
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Timepoint [4]
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From Day 1 pre-dose to 12 weeks
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Secondary outcome [5]
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Duration Of Response (DoR)
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Assessment method [5]
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The DoR is defined as the time from the date of first documented objective response (which is subsequently confirmed) until date of first documented disease progression or death (by any cause in the absence of disease progression).
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Timepoint [5]
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Through study completion, an average of 3 years
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Secondary outcome [6]
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Overall Survival(OS)
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Assessment method [6]
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OS is defined as the time from the start of treatment until death due to any cause.
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Timepoint [6]
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Through study completion, an average of 3 years
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Secondary outcome [7]
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Serum concentration
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Assessment method [7]
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To assess the serum concentration of the novel anti-cancer agents in combination.
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Timepoint [7]
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Through study completion, an average of 3 years
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Secondary outcome [8]
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Maximum plasma drug concentration (Cmax)
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Assessment method [8]
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To assess the Cmax of the novel anti-cancer agents in combination.
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Timepoint [8]
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Through study completion, an average of 3 years
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Secondary outcome [9]
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Immunogenicity of study interventions in participants receiving treatment
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Assessment method [9]
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Presence of Anti Drug Antibodies(ADAs) for study interventions in serum/plasma
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Timepoint [9]
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Through study completion, an average of 3 years
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Eligibility
Key inclusion criteria
Inclusion Criteria for All Sub-studies:
* Participant must be = 18 years of age at the time of signing the ICF
* WHO/ECOG performance status of 0 or 1
* At least 1 lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.
* Adequate bone marrow and organ function
* Life expectancy = 12 weeks
* Provision of acceptable tumour tissue
Specific Inclusion Criteria for Sub-Study 1 and Sub-Study 2:
* Histologically or cytologically documented advanced or metastatic NSCLC
* 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)
Specific Inclusion Criteria for Sub-Study 3:
* Histologically or cytologically documented advanced or metastatic non-squamous NSCLC
* Documented positive AGA and had progressed on prior targeted therapy
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria for All Sub-studies:
* As judged by the investigator, 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 protocol
* 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.
* 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
* History of another primary malignancy.
* Active infection, including TB and infections with HIV, HBV (verified by known positive HBsAg result), HCV.
* Uncontrolled or significant cardiac disease
* Receipt of prior systemic chemotherapy/chemoradiation/immunotherapy for advanced NSCLC for sub-study 1 and sub-study 2.
* 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
8/08/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
9/04/2029
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Actual
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Sample size
Target
278
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Nedlands
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Recruitment hospital [2]
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Research Site - Woodville
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Recruitment postcode(s) [1]
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6009 - Nedlands
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Recruitment postcode(s) [2]
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5011 - Woodville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Georgia
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Country [3]
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United States of America
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State/province [3]
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Maryland
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Country [4]
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United States of America
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State/province [4]
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Texas
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Country [5]
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United States of America
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State/province [5]
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Virginia
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Country [6]
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China
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State/province [6]
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Chengdu
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Country [7]
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South Korea
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State/province [7]
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Seongnam-si
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Country [8]
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Thailand
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State/province [8]
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Bangkok
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Country [9]
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Thailand
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State/province [9]
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Banphaeo
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/study/NCT07098338
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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AstraZeneca Clinical Study Information Center
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Address
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Country
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Phone
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1-877-240-9479
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07098338
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