Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
8/07/2025
Titles & IDs
Public title
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Query!
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.
Query!
Secondary ID [1]
0
0
73841937NSC3003
Query!
Secondary ID [2]
0
0
CR108856
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
MARIPOSA
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lung - Non small cell
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)
Query!
Assessment method [1]
0
0
PFS was defined as the time from randomization until the date of objective disease progression based on BICR using RECIST version 1.1 or death (by any cause) the absence of progression, whichever came first. Disease progression was defined using RECIST 1.1 as a 20 percent (%) increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 millimeters (mL). Participants who have not progressed or have not died at the time of analysis were censored at the time of the latest date of their last evaluable RECIST version 1.1 assessment.
Query!
Timepoint [1]
0
0
From randomization to either disease progression or death whichever occurs first (up to 32.8 months)
Query!
Secondary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.
Query!
Timepoint [1]
0
0
Approximately 60 months (time from the date of randomization until the date of death due to any cause)
Query!
Secondary outcome [2]
0
0
Objective Response Rate (ORR)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Approximately 32.8 months
Query!
Secondary outcome [3]
0
0
Duration of Response (DOR)
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Approximately 32.8 months
Query!
Secondary outcome [4]
0
0
Progression-Free Survival After First Subsequent Therapy (PFS2)
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Approximately 60 months
Query!
Secondary outcome [5]
0
0
Time to Symptomatic Progression (TTSP)
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Approximately 60 months
Query!
Secondary outcome [6]
0
0
Intracranial PFS
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Approximately 60 months
Query!
Secondary outcome [7]
0
0
Incidence and Severity of Adverse Events (AEs)
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Approximately 60 months
Query!
Secondary outcome [8]
0
0
Number of Participants With Clinical Laboratory Abnormalities
Query!
Assessment method [8]
0
0
Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, blood coagulation, and urine samples) will be reported.
Query!
Timepoint [8]
0
0
Approximately 60 months
Query!
Secondary outcome [9]
0
0
Number of Participants With Vital Signs Abnormalities
Query!
Assessment method [9]
0
0
Number of participants with vital signs abnormalities (temperature, heart rate, respiratory rate, oxygen saturation, blood pressure) will be reported.
Query!
Timepoint [9]
0
0
Approximately 60 months
Query!
Secondary outcome [10]
0
0
Number of Participants With Physical Examination Abnormalities
Query!
Assessment method [10]
0
0
Number of participants with physical examination abnormalities will be reported.
Query!
Timepoint [10]
0
0
Approximately 60 months
Query!
Secondary outcome [11]
0
0
Serum Concentration of Amivantamab
Query!
Assessment method [11]
0
0
Serum samples will be analyzed to determine concentrations of Amivantamab.
Query!
Timepoint [11]
0
0
Approximately 60 months
Query!
Secondary outcome [12]
0
0
Plasma Concentration of Lazertinib
Query!
Assessment method [12]
0
0
Plasma samples will be analyzed to determine concentrations of Lazertinib.
Query!
Timepoint [12]
0
0
Approximately 60 months
Query!
Secondary outcome [13]
0
0
Number of Participants With Anti-Amivantamab Antibodies
Query!
Assessment method [13]
0
0
Number of participants with antibodies to amivantamab will be reported.
Query!
Timepoint [13]
0
0
Approximately 60 months
Query!
Secondary outcome [14]
0
0
Change From Baseline in Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NCSLC-SAQ)
Query!
Assessment method [14]
0
0
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.
Query!
Timepoint [14]
0
0
Baseline up to approximately 60 months
Query!
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)
Query!
Assessment method [15]
0
0
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.
Query!
Timepoint [15]
0
0
Baseline up to approximately 60 months
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
30/09/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
29/06/2027
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1074
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Flinders Medical Centre - Bedford Park
Query!
Recruitment hospital [2]
0
0
Austin Hospital - Heidelberg
Query!
Recruitment hospital [3]
0
0
Cabrini Medical Centre - Malvern
Query!
Recruitment hospital [4]
0
0
St John of God Hospital Murdoch - Murdoch
Query!
Recruitment hospital [5]
0
0
Sir Charles Gairdner Hospital - Nedlands
Query!
Recruitment hospital [6]
0
0
Westmead Hospital - Westmead
Query!
Recruitment hospital [7]
0
0
Southern Medical Day Care Centre - Wollongong
Query!
Recruitment hospital [8]
0
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [2]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [3]
0
0
3144 - Malvern
Query!
Recruitment postcode(s) [4]
0
0
6150 - Murdoch
Query!
Recruitment postcode(s) [5]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [6]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [7]
0
0
2500 - Wollongong
Query!
Recruitment postcode(s) [8]
0
0
4102 - Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Louisiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Maryland
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Michigan
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Minnesota
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Missouri
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New Jersey
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Oregon
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Pennsylvania
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Tennessee
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Texas
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Virginia
Query!
Country [17]
0
0
Argentina
Query!
State/province [17]
0
0
Buenos Aires
Query!
Country [18]
0
0
Argentina
Query!
State/province [18]
0
0
Cordoba
Query!
Country [19]
0
0
Argentina
Query!
State/province [19]
0
0
La Rioja
Query!
Country [20]
0
0
Argentina
Query!
State/province [20]
0
0
Viedma
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Bruxelles
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Charleroi
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Leuven
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Ottignies
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Roeselare
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
Barretos
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
Belo Horizonte
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
Florianopolis
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Ijui
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
Natal
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
Pelotas
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
Porto Alegre
Query!
Country [33]
0
0
Brazil
Query!
State/province [33]
0
0
Rio De Janeiro
Query!
Country [34]
0
0
Brazil
Query!
State/province [34]
0
0
Rio de Janeiro
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
Sao Paulo
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
Sorocaba
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
Vitoria
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
Ontario
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
Quebec
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Beijing
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Changchun
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Changsha
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Changzhou
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Chengdu
Query!
Country [45]
0
0
China
Query!
State/province [45]
0
0
ChongQing
Query!
Country [46]
0
0
China
Query!
State/province [46]
0
0
Guang Zhou
Query!
Country [47]
0
0
China
Query!
State/province [47]
0
0
Guangzhou
Query!
Country [48]
0
0
China
Query!
State/province [48]
0
0
Hang Zhou
Query!
Country [49]
0
0
China
Query!
State/province [49]
0
0
Hangzhou
Query!
Country [50]
0
0
China
Query!
State/province [50]
0
0
Harbin
Query!
Country [51]
0
0
China
Query!
State/province [51]
0
0
Huizhou
Query!
Country [52]
0
0
China
Query!
State/province [52]
0
0
Linhai
Query!
Country [53]
0
0
China
Query!
State/province [53]
0
0
Nantong
Query!
Country [54]
0
0
China
Query!
State/province [54]
0
0
Shanghai
Query!
Country [55]
0
0
China
Query!
State/province [55]
0
0
Shenyang
Query!
Country [56]
0
0
China
Query!
State/province [56]
0
0
Tianjin
Query!
Country [57]
0
0
China
Query!
State/province [57]
0
0
Urumchi
Query!
Country [58]
0
0
China
Query!
State/province [58]
0
0
Wenzhou
Query!
Country [59]
0
0
China
Query!
State/province [59]
0
0
Wuhan
Query!
Country [60]
0
0
China
Query!
State/province [60]
0
0
XI An
Query!
Country [61]
0
0
China
Query!
State/province [61]
0
0
Yantai
Query!
Country [62]
0
0
China
Query!
State/province [62]
0
0
Zhengzhou
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Bordeaux
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Bron
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
La Tronche
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Lille
Query!
Country [67]
0
0
France
Query!
State/province [67]
0
0
Limoges
Query!
Country [68]
0
0
France
Query!
State/province [68]
0
0
Marseille Cedex 20
Query!
Country [69]
0
0
France
Query!
State/province [69]
0
0
Paris
Query!
Country [70]
0
0
France
Query!
State/province [70]
0
0
Pessac
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
Sain-Herblain
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
Saint Mande
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Tours
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Villejuif Cedex
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Bad Berka
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Berlin
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
Essen
Query!
Country [78]
0
0
Germany
Query!
State/province [78]
0
0
Gauting
Query!
Country [79]
0
0
Germany
Query!
State/province [79]
0
0
Halle (Saale)
Query!
Country [80]
0
0
Germany
Query!
State/province [80]
0
0
Heidelberg
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Heilbronn
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Koeln
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Leipzig
Query!
Country [84]
0
0
Germany
Query!
State/province [84]
0
0
Oldenburg
Query!
Country [85]
0
0
Germany
Query!
State/province [85]
0
0
Stuttgart
Query!
Country [86]
0
0
Hungary
Query!
State/province [86]
0
0
Budapest
Query!
Country [87]
0
0
Hungary
Query!
State/province [87]
0
0
Farkasgyepü
Query!
Country [88]
0
0
Hungary
Query!
State/province [88]
0
0
Gyöngyös
Query!
Country [89]
0
0
Hungary
Query!
State/province [89]
0
0
Szekesfehervar
Query!
Country [90]
0
0
Hungary
Query!
State/province [90]
0
0
Szombathely
Query!
Country [91]
0
0
Hungary
Query!
State/province [91]
0
0
Torokbalint
Query!
Country [92]
0
0
India
Query!
State/province [92]
0
0
Hyderabad
Query!
Country [93]
0
0
India
Query!
State/province [93]
0
0
Kolkata
Query!
Country [94]
0
0
India
Query!
State/province [94]
0
0
Mumbai
Query!
Country [95]
0
0
India
Query!
State/province [95]
0
0
Nasik
Query!
Country [96]
0
0
India
Query!
State/province [96]
0
0
Pune
Query!
Country [97]
0
0
Israel
Query!
State/province [97]
0
0
Haifa
Query!
Country [98]
0
0
Israel
Query!
State/province [98]
0
0
Jerusalem
Query!
Country [99]
0
0
Israel
Query!
State/province [99]
0
0
Kfar Saba
Query!
Country [100]
0
0
Israel
Query!
State/province [100]
0
0
Petah Tikva
Query!
Country [101]
0
0
Israel
Query!
State/province [101]
0
0
Ramat Gan
Query!
Country [102]
0
0
Israel
Query!
State/province [102]
0
0
Tel-Aviv
Query!
Country [103]
0
0
Italy
Query!
State/province [103]
0
0
Avellino
Query!
Country [104]
0
0
Italy
Query!
State/province [104]
0
0
Catania
Query!
Country [105]
0
0
Italy
Query!
State/province [105]
0
0
Meldola
Query!
Country [106]
0
0
Italy
Query!
State/province [106]
0
0
Milano
Query!
Country [107]
0
0
Italy
Query!
State/province [107]
0
0
Monza
Query!
Country [108]
0
0
Italy
Query!
State/province [108]
0
0
Napoli
Query!
Country [109]
0
0
Italy
Query!
State/province [109]
0
0
Orbassano
Query!
Country [110]
0
0
Italy
Query!
State/province [110]
0
0
Ravenna
Query!
Country [111]
0
0
Italy
Query!
State/province [111]
0
0
Roma
Query!
Country [112]
0
0
Italy
Query!
State/province [112]
0
0
Rozzano
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Bunkyo Ku
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Chuo Ku
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Fukuoka
Query!
Country [116]
0
0
Japan
Query!
State/province [116]
0
0
Himeji
Query!
Country [117]
0
0
Japan
Query!
State/province [117]
0
0
Hirakata
Query!
Country [118]
0
0
Japan
Query!
State/province [118]
0
0
Kanazawa
Query!
Country [119]
0
0
Japan
Query!
State/province [119]
0
0
Kashiwa
Query!
Country [120]
0
0
Japan
Query!
State/province [120]
0
0
Kurume
Query!
Country [121]
0
0
Japan
Query!
State/province [121]
0
0
Matsusaka
Query!
Country [122]
0
0
Japan
Query!
State/province [122]
0
0
Niigata
Query!
Country [123]
0
0
Japan
Query!
State/province [123]
0
0
Okayama
Query!
Country [124]
0
0
Japan
Query!
State/province [124]
0
0
Osaka Sayama shi
Query!
Country [125]
0
0
Japan
Query!
State/province [125]
0
0
Shibukawa
Query!
Country [126]
0
0
Japan
Query!
State/province [126]
0
0
Tokyo
Query!
Country [127]
0
0
Japan
Query!
State/province [127]
0
0
Toon-shi
Query!
Country [128]
0
0
Japan
Query!
State/province [128]
0
0
Toyonaka-shi
Query!
Country [129]
0
0
Japan
Query!
State/province [129]
0
0
Wakayama
Query!
Country [130]
0
0
Japan
Query!
State/province [130]
0
0
Yamaguchi
Query!
Country [131]
0
0
Korea, Republic of
Query!
State/province [131]
0
0
Busan
Query!
Country [132]
0
0
Korea, Republic of
Query!
State/province [132]
0
0
Cheongju-si
Query!
Country [133]
0
0
Korea, Republic of
Query!
State/province [133]
0
0
Seongnam-si
Query!
Country [134]
0
0
Korea, Republic of
Query!
State/province [134]
0
0
Seoul
Query!
Country [135]
0
0
Malaysia
Query!
State/province [135]
0
0
George Town
Query!
Country [136]
0
0
Malaysia
Query!
State/province [136]
0
0
Johor Bahru
Query!
Country [137]
0
0
Malaysia
Query!
State/province [137]
0
0
Kuala Lumpur
Query!
Country [138]
0
0
Malaysia
Query!
State/province [138]
0
0
Kuantan
Query!
Country [139]
0
0
Malaysia
Query!
State/province [139]
0
0
Petaling Jaya
Query!
Country [140]
0
0
Mexico
Query!
State/province [140]
0
0
Ciudad de Mexico
Query!
Country [141]
0
0
Mexico
Query!
State/province [141]
0
0
Guadalajara
Query!
Country [142]
0
0
Mexico
Query!
State/province [142]
0
0
Leon
Query!
Country [143]
0
0
Mexico
Query!
State/province [143]
0
0
Mexico
Query!
Country [144]
0
0
Mexico
Query!
State/province [144]
0
0
Monterrey
Query!
Country [145]
0
0
Mexico
Query!
State/province [145]
0
0
Naucalpan
Query!
Country [146]
0
0
Netherlands
Query!
State/province [146]
0
0
Arnhem
Query!
Country [147]
0
0
Netherlands
Query!
State/province [147]
0
0
Harderwijk
Query!
Country [148]
0
0
Netherlands
Query!
State/province [148]
0
0
Nijmegen
Query!
Country [149]
0
0
Netherlands
Query!
State/province [149]
0
0
s-Hertogenbosch
Query!
Country [150]
0
0
Poland
Query!
State/province [150]
0
0
Bydgoszcz
Query!
Country [151]
0
0
Poland
Query!
State/province [151]
0
0
Gdansk
Query!
Country [152]
0
0
Poland
Query!
State/province [152]
0
0
Gdynia
Query!
Country [153]
0
0
Poland
Query!
State/province [153]
0
0
Olsztyn
Query!
Country [154]
0
0
Poland
Query!
State/province [154]
0
0
Poznan
Query!
Country [155]
0
0
Poland
Query!
State/province [155]
0
0
Warszawa
Query!
Country [156]
0
0
Portugal
Query!
State/province [156]
0
0
Lisboa
Query!
Country [157]
0
0
Portugal
Query!
State/province [157]
0
0
Porto
Query!
Country [158]
0
0
Puerto Rico
Query!
State/province [158]
0
0
Rio Piedras
Query!
Country [159]
0
0
Russian Federation
Query!
State/province [159]
0
0
Irkutsk
Query!
Country [160]
0
0
Russian Federation
Query!
State/province [160]
0
0
Krasnogorsk
Query!
Country [161]
0
0
Russian Federation
Query!
State/province [161]
0
0
Krasnoyarsk
Query!
Country [162]
0
0
Russian Federation
Query!
State/province [162]
0
0
Kuzmolovsky
Query!
Country [163]
0
0
Russian Federation
Query!
State/province [163]
0
0
Moscow
Query!
Country [164]
0
0
Russian Federation
Query!
State/province [164]
0
0
Nalchik
Query!
Country [165]
0
0
Russian Federation
Query!
State/province [165]
0
0
Nizhniy Novgorod
Query!
Country [166]
0
0
Russian Federation
Query!
State/province [166]
0
0
Omsk
Query!
Country [167]
0
0
Russian Federation
Query!
State/province [167]
0
0
Saint Petersburg
Query!
Country [168]
0
0
Russian Federation
Query!
State/province [168]
0
0
St-Petersburg
Query!
Country [169]
0
0
Russian Federation
Query!
State/province [169]
0
0
Tambov
Query!
Country [170]
0
0
Russian Federation
Query!
State/province [170]
0
0
Tomsk
Query!
Country [171]
0
0
Russian Federation
Query!
State/province [171]
0
0
Ufa
Query!
Country [172]
0
0
Russian Federation
Query!
State/province [172]
0
0
Yaroslavl
Query!
Country [173]
0
0
Spain
Query!
State/province [173]
0
0
A Coruna
Query!
Country [174]
0
0
Spain
Query!
State/province [174]
0
0
Badalona
Query!
Country [175]
0
0
Spain
Query!
State/province [175]
0
0
Barcelona
Query!
Country [176]
0
0
Spain
Query!
State/province [176]
0
0
Burgos
Query!
Country [177]
0
0
Spain
Query!
State/province [177]
0
0
Girona
Query!
Country [178]
0
0
Spain
Query!
State/province [178]
0
0
Madrid
Query!
Country [179]
0
0
Spain
Query!
State/province [179]
0
0
Majadahonda
Query!
Country [180]
0
0
Spain
Query!
State/province [180]
0
0
Malaga
Query!
Country [181]
0
0
Spain
Query!
State/province [181]
0
0
Pamplona
Query!
Country [182]
0
0
Spain
Query!
State/province [182]
0
0
Seville
Query!
Country [183]
0
0
Spain
Query!
State/province [183]
0
0
Valencia
Query!
Country [184]
0
0
Spain
Query!
State/province [184]
0
0
Zaragoza
Query!
Country [185]
0
0
Taiwan
Query!
State/province [185]
0
0
Kaohsiung
Query!
Country [186]
0
0
Taiwan
Query!
State/province [186]
0
0
New Taipei
Query!
Country [187]
0
0
Taiwan
Query!
State/province [187]
0
0
Taichung
Query!
Country [188]
0
0
Taiwan
Query!
State/province [188]
0
0
Tainan
Query!
Country [189]
0
0
Taiwan
Query!
State/province [189]
0
0
Taipei City
Query!
Country [190]
0
0
Thailand
Query!
State/province [190]
0
0
Bangkok
Query!
Country [191]
0
0
Thailand
Query!
State/province [191]
0
0
Chiangmai
Query!
Country [192]
0
0
Thailand
Query!
State/province [192]
0
0
Songkla
Query!
Country [193]
0
0
Turkey
Query!
State/province [193]
0
0
Adana
Query!
Country [194]
0
0
Turkey
Query!
State/province [194]
0
0
Ankara
Query!
Country [195]
0
0
Turkey
Query!
State/province [195]
0
0
Edirne
Query!
Country [196]
0
0
Turkey
Query!
State/province [196]
0
0
Istanbul
Query!
Country [197]
0
0
Turkey
Query!
State/province [197]
0
0
Izmir
Query!
Country [198]
0
0
Turkey
Query!
State/province [198]
0
0
Konya
Query!
Country [199]
0
0
Ukraine
Query!
State/province [199]
0
0
Dnipro
Query!
Country [200]
0
0
Ukraine
Query!
State/province [200]
0
0
Kharkiv
Query!
Country [201]
0
0
Ukraine
Query!
State/province [201]
0
0
Kyiv
Query!
Country [202]
0
0
Ukraine
Query!
State/province [202]
0
0
Uzhgorod
Query!
Country [203]
0
0
United Kingdom
Query!
State/province [203]
0
0
Edinburgh
Query!
Country [204]
0
0
United Kingdom
Query!
State/province [204]
0
0
London
Query!
Country [205]
0
0
United Kingdom
Query!
State/province [205]
0
0
Manchester
Query!
Country [206]
0
0
United Kingdom
Query!
State/province [206]
0
0
Nottingham
Query!
Country [207]
0
0
United Kingdom
Query!
State/province [207]
0
0
Sutton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Janssen Research & Development, LLC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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).
Query!
Trial website
https://clinicaltrials.gov/study/NCT04487080
Query!
Trial related presentations / publications
Cho BC, Felip E, Hayashi H, Thomas M, Lu S, Besse B, Sun T, Martinez M, Sethi SN, Shreeve SM, Spira AI. MARIPOSA: phase 3 study of first-line amivantamab + lazertinib versus osimertinib in EGFR-mutant non-small-cell lung cancer. Future Oncol. 2022 Feb;18(6):639-647. doi: 10.2217/fon-2021-0923. Epub 2021 Dec 16.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
Query!
Address
0
0
Janssen Research & Development, LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/80/NCT04487080/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/80/NCT04487080/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04487080
Download to PDF