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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06417814




Registration number
NCT06417814
Ethics application status
Date submitted
13/05/2024
Date registered
16/05/2024

Titles & IDs
Public title
A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Scientific title
A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants With EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Has Progressed on Prior Osimertinib Treatment (TROPION-Lung15)
Secondary ID [1] 0 0
2024-511362-37-00
Secondary ID [2] 0 0
D516KC00001
Universal Trial Number (UTN)
Trial acronym
TROPION-Lung15
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dato-DXd
Treatment: Drugs - Osimertinib
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin

Experimental: Group 1: Dato-DXd + Osimertinib Combination Therapy - Participants will receive Dato-DXd 6 mg/kg as IV infusion Q3W on Day 1 of every 21-day cycle, and osimertinib 80 milligrams (mg) once daily (QD) orally, until RECIST v1.1-defined radiological progression by investigator, unacceptable toxicity, or other discontinuation criterion is met.

Experimental: Group 2: Dato-DXd Monotherapy - Participants will receive Dato-DXd 6 milligrams per kilogram (mg/kg) as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of every 21-day cycle, until RECIST v1.1-defined radiological progression by investigator, unacceptable toxicity, or other discontinuation criterion is met.

Experimental: Group 3: Platinum-based Doublet Chemotherapy - Participants will receive pemetrexed 500 milligrams per meter square (mg/m2) in combination with carboplatin (AUC5) or cisplatin 75 mg/m2 as IV infusion Q3W for 4 cycles followed by pemetrexed maintenance 500 mg/m2 as IV infusion Q3W, until RECIST v1.1-defined radiological progression by investigator, unacceptable toxicity, or another discontinuation criterion is met.


Treatment: Drugs: Dato-DXd
Dato-DXd will be administered as IV infusion.

Treatment: Drugs: Osimertinib
Osimertinib will be administered orally.

Treatment: Drugs: Pemetrexed
Pemetrexed will be administered as IV infusion.

Treatment: Drugs: Carboplatin
Carboplatin will be administered as IV infusion.

Treatment: Drugs: Cisplatin
Cisplatin will be administered as IV infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression free Survival (PFS)
Timepoint [1] 0 0
Up to 2.5 years
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to 3.5 years
Secondary outcome [2] 0 0
Central Nervous System Progression-free Survival (CNS PFS)
Timepoint [2] 0 0
Up to 2.5 years
Secondary outcome [3] 0 0
Objective Response Rate (ORR)
Timepoint [3] 0 0
Up to 2.5 years
Secondary outcome [4] 0 0
Duration of Response (DoR)
Timepoint [4] 0 0
Up to 2.5 years
Secondary outcome [5] 0 0
Progression-free Survival-2 (PFS-2)
Timepoint [5] 0 0
Up to 3.5 years
Secondary outcome [6] 0 0
Objective Response Rate (ORR) Using CNS Modified RECIST v1.1
Timepoint [6] 0 0
Up to 2.5 years
Secondary outcome [7] 0 0
Duration of Response (DoR) Using CNS Modified RECIST v1.1
Timepoint [7] 0 0
Up to 2.5 years
Secondary outcome [8] 0 0
Time to Deterioration in Pulmonary Symptoms
Timepoint [8] 0 0
Up to 3.5 years
Secondary outcome [9] 0 0
Time to Deterioration in Physical Functioning
Timepoint [9] 0 0
Up to 3.5 years
Secondary outcome [10] 0 0
Time to Deterioration in Global Health Status (GHS)/Quality of Life (QoL)
Timepoint [10] 0 0
Up to 3.5 years
Secondary outcome [11] 0 0
Pharmacokinetics (PK) of Dato-DXd
Timepoint [11] 0 0
Up to 3.5 years
Secondary outcome [12] 0 0
Immunogenicity of Dato-DXd
Timepoint [12] 0 0
Up to 3.5 years

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed non-squamous NSCLC.
* Must have evidence of documented pre-existing EGFRm information (EGFRm known to be associated with (epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor [TKis] sensitivity [Ex19del, L858R, G719X, S768I, or L861Q], either alone or in combination with other EGFR mutations, which may include T790M).
* Documented extra-cranial radiologic progression on prior osimertinib monotherapy (as most recent line of treatment) in the adjuvant, locally advanced, or metastatic setting.
* Less than or equal to (<=2) prior lines of EGFR TKIs (osimertinib is the only permitted prior third generation EGFR TKI).
* At least one lesion, not previously irradiated, that qualifies as a RECIST v1.1 TL at baseline and can be accurately measured at baseline.
* World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate bone marrow reserve and organ function within 7 days before randomization.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Use of chemotherapy, vascular endothelial growth factor inhibitor, immunotherapy or any anti-cancer therapy in the metastatic setting. Platinum-based chemotherapy in non-metastatic setting within 12 months prior to randomization.
* History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before the first dose of study intervention.
* Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease.
* Has significant third-space fluid retention (example [eg.], ascites or pleural effusion) as judged by the investigator and is not amenable for required repeated drainage.
* History of non-infectious ILD/pneumonitis including radiation pneumonitis that required steroids or drug-induced ILD, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
* Has severe pulmonary function compromise resulting from intercurrent pulmonary illnesses.
* Unstable spinal cord compression and/or unstable brain metastases.
* Participants with symptomatic brain metastases (including leptomeningeal involvement).
* Clinically significant corneal disease.
* Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, suspected infections or inability to rule out infections.
* Has known human immunodeficiency virus (HIV) infection that is not well controlled.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/11/2027
Actual
Sample size
Target
630
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
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Research Site - Fitzroy
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Research Site - Heidelberg
Recruitment hospital [3] 0 0
Research Site - Kogarah
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Research Site - Liverpool
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Research Site - Port Macquarie
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Research Site - St Leonards
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Research Site - Westmead
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Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
VIC3065 - Fitzroy
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3084 - Heidelberg
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2217 - Kogarah
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2170 - Liverpool
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6009 - Nedlands
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2444 - Port Macquarie
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2065 - St Leonards
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2145 - Westmead
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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Birmingham
Country [194] 0 0
United Kingdom
State/province [194] 0 0
Cambridge
Country [195] 0 0
United Kingdom
State/province [195] 0 0
Glasgow
Country [196] 0 0
United Kingdom
State/province [196] 0 0
Leicester
Country [197] 0 0
United Kingdom
State/province [197] 0 0
London
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Manchester
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Middlesbrough
Country [200] 0 0
Vietnam
State/province [200] 0 0
Hanoi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Daiichi Sankyo
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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. All request 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 approved.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.

For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


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/NCT06417814