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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04487080
Ethics application status
Date submitted
23/07/2020
Date registered
27/07/2020
Date last updated
2/04/2021

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) - PFS is defined as the time from randomization until the date of objective disease progression or death, whichever occured first, based on BICR using response evaluation criteria in solid tumors (RECIST) v1.1.
Timepoint [1] 0 0
Up to approximately 42 months
Secondary outcome [1] 0 0
Overall Survival (OS) - Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.
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) - ORR is defined as the percentage of participants who achieve either a complete response (CR) or partial response (PR) as defined by BICR using RECIST v1.1 criteria.
Timepoint [2] 0 0
Up to approximately 42 months
Secondary outcome [3] 0 0
Duration of Response (DOR) - DOR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, only for participants who achieve CR or PR as determined by the investigator using RECIST v1.1 criteria.
Timepoint [3] 0 0
Up to approximately 42 months
Secondary outcome [4] 0 0
Progression-Free Survival After First Subsequent Therapy (PFS2) - The PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent anticancer therapy, based on investigator assessment (after that used for PFS) or death, whichever comes first.
Timepoint [4] 0 0
Up to approximately 42 months
Secondary outcome [5] 0 0
Time to Symptomatic Progression (TTSP) - TTSP is defined as the time from randomization to documentation in the electronic case report form (eCRF) of any of the following (whichever occurs earlier): onset of new symptoms or symptom worsening that is considered by the investigator to be related to lung cancer and requires either a change in anticancer treatment and/or clinical intervention to manage symptoms.
Timepoint [5] 0 0
Up to approximately 42 months
Secondary outcome [6] 0 0
Intracranial PFS - Intracranial PFS is defined as the time from randomization until the date of objective intracranial disease progression or death, whichever comes first, based on BICR using RECIST v1.1.
Timepoint [6] 0 0
Up to approximately 42 months
Secondary outcome [7] 0 0
Incidence and Severity of Adverse Events (AEs) - Incidence and severity of treatment emergent adverse events (TEAEs) will be reported. Any adverse event occurring at or after the initial administration of study treatment through the day of last dose plus 30 days, or until the start of subsequent anticancer therapy (if earlier), is considered to be treatment emergent.
Timepoint [7] 0 0
Up to approximately 60 months
Secondary outcome [8] 0 0
Number of Participants with Clinical Laboratory Abnormalities - Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, blood coagulation, and urine samples) will be reported.
Timepoint [8] 0 0
Up to approximately 60 months
Secondary outcome [9] 0 0
Number of Participants with Vital Signs Abnormalities - Number of participants with vital signs abnormalities (temperature, heart rate, respiratory rate, oxygen saturation, blood pressure) will be reported.
Timepoint [9] 0 0
Up to approximately 60 months
Secondary outcome [10] 0 0
Number of Participants with Physical Examination Abnormalities - Number of participants with physical examination abnormalities will be reported.
Timepoint [10] 0 0
Up to approximately 60 months
Secondary outcome [11] 0 0
Serum Concentration of Amivantamab - Serum samples will be analyzed to determine concentrations of amivantamab.
Timepoint [11] 0 0
Up to approximately 42 months
Secondary outcome [12] 0 0
Plasma Concentration of Lazertinib - Plasma samples will be analyzed to determine concentrations of lazertinib.
Timepoint [12] 0 0
Up to approximately 42 months
Secondary outcome [13] 0 0
Number of Participants with Anti-Amivantamab Antibodies - Number of participants with antibodies to amivantamab will be reported.
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) - The NSCLC-SAQ contains 7 items that assess cough, pain, dyspnea, fatigue, and poor appetite over a 7-day recall period. Each multi-item scale and individual item will be summarized using count and percent by visit.
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) - EORTC-QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies.
Timepoint [15] 0 0
Baseline Up to approximately 42 months

Eligibility
Key inclusion criteria
- Participant must have histologically or cytologically confirmed, locally advanced or
metastatic non-small cell lung cancer (NSCLC) not amenable to curative therapy

- Participant must have a tumor that was previously determined to have 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. The biopsy must have been obtained at or after the diagnosis of
advanced disease

- Unstained tumor tissue (in a quantity sufficient to allow for central analysis of
epidermal growth factor receptor (EGFR) mutation status, see Laboratory Manual) and
blood (for circulating tumor deoxyribonucleic acid [ctDNA], digital droplet polymerase
chain reaction [ddPCR], and pharmacogenomic analysis), both collected at or after the
diagnosis of locally advanced or metastatic NSCLC, must be provided

- 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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participant has received any prior systemic treatment for locally advanced or
metastatic disease (adjuvant or neoadjuvant therapy 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 has spinal cord compression that has not been definitively treated with
surgery or radiation or requires steroid treatment within 2 weeks prior to
randomization

- 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
St George Hospital - Kogarah
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Cabrini Medical Centre - Malvern
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St John of God Hospital Murdoch - Murdoch
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Sir Charles Gairdner Hospital - Nedlands
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Westmead Hospital - Westmead
Recruitment hospital [8] 0 0
Southern Medical Day Care Centre - Wollongong
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Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
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3084 - Heidelberg
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2217 - Kogarah
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3144 - Malvern
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6150 - Murdoch
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6009 - Nedlands
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment postcode(s) [8] 0 0
2500 - Wollongong
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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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/show/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
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
JNJ.CT@sylogent.com
Contact person for scientific queries

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