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    Summary
    EudraCT Number:2020-000633-40
    Sponsor's Protocol Code Number:61186372NSC3001
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-10-02
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPortugal - INFARMED
    A.2EudraCT number2020-000633-40
    A.3Full title of the trial
    A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared with Carboplatin-Pemetrexed, in Patients with EGFR Exon 20ins-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared with Carboplatin-Pemetrexed, in Patients with EGFR Exon 20ins-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
    A.3.2Name or abbreviated title of the trial where available
    PAPILLON
    A.4.1Sponsor's protocol code number61186372NSC3001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Research and Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag Farmaceutica Lda.
    B.5.2Functional name of contact pointGlobal Clinical Operations Portugal
    B.5.3 Address:
    B.5.3.1Street AddressLagoas Park, Edificio 9
    B.5.3.2Town/ cityPorto Salvo
    B.5.3.3Post code2740-262
    B.5.3.4CountryPortugal
    B.5.4Telephone number+34672 650 377
    B.5.5Fax number+34917228628
    B.5.6E-maillbascone@its.jnj.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAmivantamab
    D.3.2Product code JNJ-61186372
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAmivantamab
    D.3.9.1CAS number 2171511-58-1
    D.3.9.2Current sponsor codeJNJ-61186372
    D.3.9.4EV Substance CodeSUB193051
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    EGFR Exon 20ins-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
    E.1.1.1Medical condition in easily understood language
    A specific type of lung cancer called "Non-Small Cell Lung Cancer"
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to compare the efficacy, as demonstrated by PFS, in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    1. To further assess the clinical benefit achieved with amivantamab in combination with chemotherapy, versus chemotherapy alone
    2. To assess the safety in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone
    3. To assess the relationship between pharmacokinetics or immunogenicity and selected endpoints (including but not limited to efficacy, safety and/or PRO)
    4. To assess health-related quality of life and disease related symptoms in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant must be ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place).
    2. Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous NSCLC with documented primary EGFR Exon 20ins activating mutation (a copy of the mutation analysis must be submitted during screening) performed by a Clinical Laboratory Improvement Amendments (CLIA) certified (US sites) or an accredited (outside of the US) local laboratory.
    3. Participant must have measurable disease according to RECIST v1.1. If only one measurable lesion exists, it may be used for the screening biopsy (if required for submission of tumor tissue) if the baseline tumor assessment scans are performed ≥14 days after the biopsy.
    4. Participant must have ECOG performance status 0 or 1.
    5. Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream.
    6. Participant must have adequate organ and bone marrow function as follows, without history of red blood cell transfusion or platelet transfusion within 7 days prior to the date of the laboratory test.
    • Hemoglobin ≥10 g/dL
    • Absolute neutrophil count ≥1.5x109/L, without use of granulocyte colony stimulating factor (G-CSF) within 10 days prior to the date of the test
    • Platelets ≥100x109/L
    • ALT and aspartate aminotransferase (AST) ≤3×upper limit of normal (ULN)
    • Total bilirubin ≤1.5xULN (participants with Gilbert’s syndrome can enroll if conjugated bilirubin is within normal limits)
    • Creatinine clearance >50 mL/min as measured or calculated by Cockroft Gault formula
    7. Participant must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
    8. A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.
    9. A female participant must be (as defined in Appendix 4: Contraceptive
    and Barrier Guidance) either of the following:
    a. Not of childbearing potential
    b. Of childbearing potential and practicing 2 methods of contraception,
    including 1 highly effective, user independent method. Examples of
    highly effective methods of contraception are located in Appendix 4:
    Contraceptive and Barrier Guidance.
    Participant must agree to continue contraception throughout the study
    and through 6 months after the last dose of study treatment.
    Note: If the childbearing potential changes after start of the study (eg,
    woman who is not heterosexually active becomes active, premenarchal
    woman experiences menarche) the woman must begin 2 methods of
    birth control, as described above.
    10. A female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study treatment.
    11. A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 6 months after receiving the last dose of study treatment. If the participant is vasectomized, he must still use a condom (with or without spermicide) for prevention of passage of exposure through ejaculation, but his female partner is not required to use contraception.
    A male participant who is sexually active with a woman of childbearing potential must agree to use a condom with spermicidal foam/gel/film/cream/suppository and his partner must also be practicing a highly effective method of contraception (ie, established use of oral, injected, or implanted hormonal methods of contraception; placement of an intrauterine device [IUD] or intrauterine hormone-releasing system [IUS]).
    12. A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of study treatment.
    13. Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
    E.4Principal exclusion criteria
    1. Participant has received any prior systemic treatment for locally advanced or metastatic disease, with following exceptions noted in section 5.2 of the protocol
    2. Participant has evidence of synchronous NSCLC disease (as suggested by genetic characterization or radiographic appearance).
    3. Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible). If brain metastases are diagnosed on Screening imaging, the participant may be rescreened for eligibility after definitive treatment.
    4. Participant has a history of leptomeningeal disease.
    5. Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation.
    6. Participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy [eg, bone metastases or metastases causing nerve impingement] should be treated prior to Screening).
    7. Participant has a medical history of ILD, including drug-induced ILD, or radiation pneumonitis.
    8. Participant has an active malignancy (ie, ongoing, progressing or requiring treatment change in the last 24 months) other than the
    disease being treated under study.Exceptions noted in section 5.2. of the protocol.
    9. Participant has a history of clinically significant cardiovascular disease. Examples noted in section 5.2 of the protocol.
    10. Participant has at Screening:
    • Positive hepatitis B (hepatitis B virus [HBV]) surface antigen (HBsAg)
    • Positive hepatitis C (hepatitis C virus [HCV]) antibody (anti-HCV)
    • Other clinically active infectious liver disease
    11. Participant is known to be positive for human immunodeficiency virus (HIV) and meets one of the following criteria:
    • Not receiving highly active antiretroviral therapy (ART)
    •Had a change in antiretroviral therapy within 6 months of the start of
    screening
    • Receiving antiretroviral therapy that may interfere with study
    treatment (consult Sponsor for review of medication prior to enrollment)
    • CD4 count <350 at screening
    •AIDS-defining opportunistic infection within 6 months of start of
    screening
    • Not agreeing to start ART and be on ART >4 weeks plus having HIV
    viral load <400 copies/mL at end of 4-week period (to ensure ART is
    tolerated and HIV controlled).
    12. Participant has an uncontrolled illness, including but not limited to the following:
    • Diabetes
    • Ongoing or active bacterial infection (includes infection requiring treatment with antimicrobial therapy [participants will be required to complete antibiotics 1 week before randomization]), symptomatic viral infection, or any other clinically significant infection
    • Active bleeding diathesis
    • Impaired oxygenation requiring supplemental oxygen
    • Psychiatric illness/social situation that would limit compliance with study requirements
    13. Participant had major surgery (eg, requiring general anesthesia) or significant traumatic injury within 4 weeks of randomization, will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study.
    Note: Participants with planned surgical procedures to be conducted under local anesthesia may participate.
    14. Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent2,5). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid.
    15. Participant has a history of hypersensitivity to the excipients of amivantamab (refer to the IB12).
    16. Participant has received a live or live attenuated vaccine within 3 months before randomization.
    17. Participant has received an investigational intervention (including investigational vaccines) within 6 weeks before randomization.
    18. Participant is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment.
    19. Participant plans to father a child while enrolled in this study or within 6 months after the last dose of study treatment.
    20. Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) (using RECIST v1.1 guidelines), as assessed by blinded independent central review (BICR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomization, until the date of objective disease progression based on BICR using RECIST v1.1 or death (by any cause) in the absence of progression, whichever comes first.
    E.5.2Secondary end point(s)
    1. Objective response rate
    2. Duration of response
    3. Overall survival
    4. Time to subsequent therapy
    5. PFS after first subsequent therapy
    6. Time to symptomatic progression
    7. Incidence and severity of adverse events and laboratory abnormalities, assessment of vital signs, and physical examination abnormalities
    8. a. Pharmacokinetic sample: Serum amivantamab concentrations
    • Ceoi: end of infusion serum concentration
    • Ceoi,ss: end of infusion serum concentration at steady state
    • Ctrough: serum concentration immediately prior the next study treatment administration
    • Ctrough,ss: serum concentration immediately prior the next study treatment administration at steady state
    • Cmax: maximum serum concentration
    b. Immunogenecity sample: anti-amivantamab antibodies
    9. EORTC-QLQ-C30
    10. PROMIS PF
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. to 6.
    From randomization until the date of documented progression or death, whichever comes first
    7. Throughout study
    8.a. Day 1 (D1) of Cycle 1(C1), C2, C3, C5, C7, C9, C11, C13 and C1D2, and End of Treatment visit (ETV)
    b. D1 of C1, C2, C3, C5, C7, C9, C11, C13 and ETV
    9 and 10. EORTC-QLQ-C30: D1 of C1, C3, C5, C7, C9 etc, EOT, Follow-up every 12 weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenecity, Tolerability, Biomarker evaluation, Quality of life
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Brazil
    Canada
    China
    France
    Germany
    Hong Kong
    Hungary
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    Poland
    Portugal
    Russian Federation
    Spain
    Taiwan
    Thailand
    Turkey
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Approximately 48 months after the first participant is randomized
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 300
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-15
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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