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A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions (PAPILLON)

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ClinicalTrials.gov Identifier: NCT04538664
Recruitment Status : Recruiting
First Posted : September 4, 2020
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE August 31, 2020
First Posted Date  ICMJE September 4, 2020
Last Update Posted Date January 8, 2021
Actual Study Start Date  ICMJE October 13, 2020
Estimated Primary Completion Date January 12, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2020)
Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to 18 months ]
PFS is defined as the time from randomization until the date of objective disease progression based on blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death (by any cause) in the absence of progression, whichever comes first.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2020)
  • Objective Response Rate (ORR) [ Time Frame: Up to 48 months ]
    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.
  • Duration of Response (DoR) [ Time Frame: Up to 48 months ]
    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.
  • Overall Survival (OS) [ Time Frame: Up to 48 months ]
    Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.
  • Time to Subsequent Therapy (TST) [ Time Frame: Up to 48 months ]
    TST is defined as the time from the date of randomization to the start date of the subsequent anti-cancer therapy following study treatment discontinuation, or death.
  • Progression-Free Survival After First Subsequent Therapy (PFS2) [ Time Frame: Up to 48 months ]
    PFS2 is defined as the time from the date of randomization to the earliest of the progression event subsequent to that used for the primary variable PFS or death after starting the next line of treatment.
  • Time to Symptomatic Progression (TTSP) [ Time Frame: Up to 48 months ]
    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.
  • Incidence and Severity of Adverse Events (AEs) [ Time Frame: Up to 48 months ]
    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
  • Number of Participants with Clinical Laboratory Abnormalities [ Time Frame: Up to 48 months ]
    Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, blood coagulation, and urine samples) will be reported.
  • Number of Participants with Vital Signs Abnormalities [ Time Frame: Up to 48 months ]
    Number of participants with vital signs abnormalities (temperature, heart rate, respiratory rate, oxygen saturation, blood pressure) will be reported.
  • Number of Participants with Physical Examination Abnormalities [ Time Frame: Up to 48 months ]
    Number of participants with physical examination abnormalities will be reported.
  • Serum Concentration of Amivantamab [ Time Frame: Up to 48 months ]
    Serum samples will be analyzed to determine concentrations of amivantamab.
  • Number of Participants with Anti-Amivantamab Antibodies [ Time Frame: Up to 48 months ]
    Number of participants with antibodies to amivantamab will be reported.
  • European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) [ Time Frame: Up to 48 months ]
    The EORTC QLQ-C30 includes 30 items in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single symptom items. The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
  • Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) [ Time Frame: Up to 48 months ]
    PROMIS-PF is used to characterize and better understand overall health, level of physical disability, and general well-being. Physical function is a foundation for commonly used general and cancer-specific patient reported outcomes (PRO) measures.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions
Official Title  ICMJE 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
Brief Summary The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations.
Detailed Description Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer (almost 20 percent [%] of cancer deaths); NSCLC accounts for 80% to 85% of lung cancers. Amivantamab (JNJ-61186372) is a low fucose, fully human immunoglobulin G1 (IgG1)-based bispecific antibody directed against epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET) tyrosine kinase receptors that is being developed for the treatment of solid tumors. The hypothesis is that amivantamab, when given in combination with standard of care carboplatin-pemetrexed chemotherapy, will prolong PFS compared with carboplatin-pemetrexed in patients with locally advanced or metastatic NSCLC characterized by EGFR Exon 20ins activating mutations. The study will include a Screening phase (28 days), a Treatment phase (from Cycle 1 Day 1 [21-day cycle] till end of treatment [30 days after last dose]) and a Follow up phase (from the end of treatment visit and until the end of study, death, loss to follow-up, or withdrawal of consent from participation in the study, whichever comes first). An independent data monitoring committee (IDMC) will be commissioned for the periodic review of safety and tolerability data, as well as planned efficacy analyses. Efficacy assessments will include disease assessment, symptomatic progression and patient-reported outcome. Safety assessments will include physical examinations, vital signs, electrocardiograms (ECGs), Eastern Cooperative Oncology Group (ECOG) performance status and clinical safety laboratory assessments (serum chemistry, hematology, coagulation, and urinalysis). The total duration of the study is up to 48 months.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: Amivantamab
    Amivantamab will be administered as an IV infusion at a dose of 1400 mg (1750 mg if body weight is >=80 kilogram [kg]) by once weekly up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is >=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3.
    Other Name: JNJ-61186372
  • Drug: Pemetrexed
    Pemetrexed will be administration as 500 mg/m^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression in Arms A and B.
  • Drug: Carboplatin
    Carboplatin will be administration as AUC 5 IV infusion for up to 4 cycles on Day 1 of each 21-day cycle.
Study Arms  ICMJE
  • Experimental: Arm A: Amivantamab + Chemotherapy

    Participants will receive pemetrexed 500 milligram per meter square (mg/m^2) intravenous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin for up to 4 cycles, and then as maintenance monotherapy until disease progression.

    Carboplatin area under the concentration-time curve 5 milligram per milliliter (mg/mL) per minute (AUC 5) will be administered as IV infusion on Day 1 of each 21 day cycle, for up to 4 cycles.

    Participants will receive amivantamab 1400 mg (1750 mg if body weight is >=80 kilogram [kg]) by IV infusion once weekly up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is >=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3.

    Interventions:
    • Drug: Amivantamab
    • Drug: Pemetrexed
    • Drug: Carboplatin
  • Experimental: Arm B: Chemotherapy Alone

    Participants will receive pemetrexed 500 mg/m^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin for up to 4 cycles, and then as maintenance monotherapy until disease progression.

    Carboplatin AUC 5 IV infusion will be administered on Day 1 of each 21-day cycle for up to 4 cycles.

    Interventions:
    • Drug: Pemetrexed
    • Drug: Carboplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 31, 2020)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 8, 2024
Estimated Primary Completion Date January 12, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation
  • Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • 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
  • 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

Exclusion Criteria:

  • Participant has evidence of synchronous NSCLC with an EGFR mutation other than EGFR Exon 20ins
  • 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)
  • Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation
  • Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis
  • Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Canada,   China,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Poland,   Portugal,   Puerto Rico,   Russian Federation,   Spain,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04538664
Other Study ID Numbers  ICMJE CR108850
2020-000633-40 ( EudraCT Number )
61186372NSC3001 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

URL: https://www.janssen.com/clinical-trials/transparency
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP