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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04487080




Registration number
NCT04487080
Ethics application status
Date submitted
23/07/2020
Date registered
27/07/2020
Date last updated
17/07/2024

Titles & IDs
Public title
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Scientific title
A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
Secondary ID [1] 0 0
2020-000743-31
Secondary ID [2] 0 0
CR108856
Universal Trial Number (UTN)
Trial acronym
MARIPOSA
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Amivantamab
Treatment: Drugs - Osimertinib
Treatment: Drugs - Lazertinib
Treatment: Drugs - Placebo

Experimental: Treatment Arm A (Open-label): Amivantamab and Lazertinib - Participants will receive amivantamab 1050 milligram (mg) intravenously (IV) for body weight less than (\<) 80 kilogram (kg) and 1400 mg for body weight greater than or equal to (\>=) 80 kg in 28-day cycles: once weekly in Cycle 1 (with a split dose on Days 1-2), and then every 2 weeks in subsequent cycles. Lazertinib will be administered 240 mg (80\*3) orally once daily.

Active comparator: Treatment Arm B (Double-blind): Osimertinib+Placebo Lazertinib - Participants will receive osimertinib 80 mg orally once daily plus matching placebo of lazertinib 240 mg (80\*3) orally once daily.

Experimental: Treatment Arm C (Double-blind): Lazertinib+Placebo Osimertinib - Participants will receive lazertinib 240 mg (80\*3) orally once daily plus matching placebo of osimertinib 80 mg orally once daily.


Treatment: Drugs: Amivantamab
Participants will receive amivantamab intravenously.

Treatment: Drugs: Osimertinib
Participants will receive osimertinib capsules orally.

Treatment: Drugs: Lazertinib
Participants will receive lazertinib tablets orally.

Treatment: Drugs: Placebo
Participants will receive matching placebo orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) According to RECIST v1.1 by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Up to approximately 42 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 60 months (time from the date of randomization until the date of death due to any cause)
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
Up to approximately 42 months
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
Up to approximately 42 months
Secondary outcome [4] 0 0
Progression-Free Survival After First Subsequent Therapy (PFS2)
Timepoint [4] 0 0
Up to approximately 42 months
Secondary outcome [5] 0 0
Time to Symptomatic Progression (TTSP)
Timepoint [5] 0 0
Up to approximately 42 months
Secondary outcome [6] 0 0
Intracranial PFS
Timepoint [6] 0 0
Up to approximately 42 months
Secondary outcome [7] 0 0
Incidence and Severity of Adverse Events (AEs)
Timepoint [7] 0 0
Up to approximately 60 months
Secondary outcome [8] 0 0
Number of Participants with Clinical Laboratory Abnormalities
Timepoint [8] 0 0
Up to approximately 60 months
Secondary outcome [9] 0 0
Number of Participants with Vital Signs Abnormalities
Timepoint [9] 0 0
Up to approximately 60 months
Secondary outcome [10] 0 0
Number of Participants with Physical Examination Abnormalities
Timepoint [10] 0 0
Up to approximately 60 months
Secondary outcome [11] 0 0
Serum Concentration of Amivantamab
Timepoint [11] 0 0
Up to approximately 42 months
Secondary outcome [12] 0 0
Plasma Concentration of Lazertinib
Timepoint [12] 0 0
Up to approximately 42 months
Secondary outcome [13] 0 0
Number of Participants with Anti-Amivantamab Antibodies
Timepoint [13] 0 0
Up to approximately 42 months
Secondary outcome [14] 0 0
Change from Baseline in Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NCSLC-SAQ)
Timepoint [14] 0 0
Baseline Up to approximately 42 months
Secondary outcome [15] 0 0
Change from Baseline in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Timepoint [15] 0 0
Baseline Up to approximately 42 months

Eligibility
Key inclusion criteria
* Participant must have newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation
* The tumor harbors exon 19 deletions (Exon 19del) or Exon 21 L858R substitution, as detected by an food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United states [US]) or an accredited local laboratory (sites outside of the US) in accordance with site standard of care
* Mandatory submission of unstained tissue from tumor (in a quantity sufficient to allow for central analysis of EGFR mutation status and blood (for circulating tumor deoxyribonucleic acid [ctDNA], digital droplet polymerase chain reaction [ddPCR], and pharmacogenomic analysis)
* Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level
* Participant must have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) v1.1 that has not been previously irradiated. Measurable lesions should not have been biopsied during screening, but if only 1 non-irradiated measurable lesion exists, it may undergo a diagnostic biopsy and be acceptable as a target lesion, provided the baseline tumor assessment scans are performed at least 14 days after the biopsy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participant has received any prior systemic treatment at any time for locally advanced Stage III or metastatic Stage IV disease (adjuvant or neoadjuvant therapy for Stage I or II disease is allowed, if administered more than 12 months prior to the development of locally advanced or metastatic disease)
* Participant has an active or past medical history of leptomeningeal disease
* Participant with untreated spinal cord compression. A participant that has been definitively treated with surgery or radiation and has a stable neurological status for at least 2 weeks prior to randomization is eligible provided they are off corticosteroid treatment or receiving low-dose corticosteroid treatment less than or equal to (<=) 10 milligrams per day (mg/day) prednisone or equivalent
* Participant has an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis
* Participant has known allergy, hypersensitivity, or intolerance to the excipients used in formulation of amivantamab, lazertinib, or osimertinib, or any contraindication to the use of osimertinib
* Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/06/2027
Actual
Sample size
Target
Accrual to date
Final
1074
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [3] 0 0
Cabrini Medical Centre - Malvern
Recruitment hospital [4] 0 0
St John of God Hospital Murdoch - Murdoch
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [6] 0 0
Westmead Hospital - Westmead
Recruitment hospital [7] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
3144 - Malvern
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
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6009 - Nedlands
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment postcode(s) [7] 0 0
2500 - Wollongong
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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Ramat Gan
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Avellino
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Niigata
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Osaka Sayama shi
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Tokyo
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Harderwijk
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Nijmegen
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Turkey
State/province [195] 0 0
Edirne
Country [196] 0 0
Turkey
State/province [196] 0 0
Istanbul
Country [197] 0 0
Turkey
State/province [197] 0 0
Izmir
Country [198] 0 0
Turkey
State/province [198] 0 0
Konya
Country [199] 0 0
Ukraine
State/province [199] 0 0
Dnipro
Country [200] 0 0
Ukraine
State/province [200] 0 0
Kharkiv
Country [201] 0 0
Ukraine
State/province [201] 0 0
Kyiv
Country [202] 0 0
Ukraine
State/province [202] 0 0
Uzhgorod
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Edinburgh
Country [204] 0 0
United Kingdom
State/province [204] 0 0
London
Country [205] 0 0
United Kingdom
State/province [205] 0 0
Manchester
Country [206] 0 0
United Kingdom
State/province [206] 0 0
Nottingham
Country [207] 0 0
United Kingdom
State/province [207] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions \[Exon 19del\] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
Trial website
https://clinicaltrials.gov/study/NCT04487080
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04487080