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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04538664




Registration number
NCT04538664
Ethics application status
Date submitted
31/08/2020
Date registered
4/09/2020
Date last updated
30/04/2021

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
2020-000633-40
Secondary ID [2] 0 0
CR108850
Universal Trial Number (UTN)
Trial acronym
PAPILLON
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(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Amivantamab
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Carboplatin

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.

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.


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: Carboplatin
Carboplatin will be administration as AUC 5 IV infusion for up to 4 cycles on Day 1 of each 21-day cycle.

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 as Assessed by Blinded Independent Central Review (BICR) - 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.
Timepoint [1] 0 0
Up to 18 months
Secondary outcome [1] 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 [1] 0 0
Up to 48 months
Secondary outcome [2] 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 [2] 0 0
Up to 48 months
Secondary outcome [3] 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 [3] 0 0
Up to 48 months
Secondary outcome [4] 0 0
Time to Subsequent Therapy (TST) - 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.
Timepoint [4] 0 0
Up to 48 months
Secondary outcome [5] 0 0
Progression-Free Survival After First Subsequent Therapy (PFS2) - 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.
Timepoint [5] 0 0
Up to 48 months
Secondary outcome [6] 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 [6] 0 0
Up to 48 months
Secondary outcome [7] 0 0
Incidence and Severity of Adverse Events (AEs) - 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.
Timepoint [7] 0 0
Up to 48 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 48 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 48 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 48 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 48 months
Secondary outcome [12] 0 0
Number of Participants with Anti-Amivantamab Antibodies - Number of participants with antibodies to amivantamab will be reported.
Timepoint [12] 0 0
Up to 48 months
Secondary outcome [13] 0 0
European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) - 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.
Timepoint [13] 0 0
Up to 48 months
Secondary outcome [14] 0 0
Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) - 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.
Timepoint [14] 0 0
Up to 48 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

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
Open (masking not used)
Who is / are masked / blinded?



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
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [3] 0 0
St George Hospital - Kogarah
Recruitment hospital [4] 0 0
Cabrini Medical Centre - Malvern
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
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2217 - Kogarah
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
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Bangkok
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Thailand
State/province [182] 0 0
Songkla
Country [183] 0 0
Turkey
State/province [183] 0 0
Adana
Country [184] 0 0
Turkey
State/province [184] 0 0
Ankara
Country [185] 0 0
Turkey
State/province [185] 0 0
Edirne
Country [186] 0 0
Turkey
State/province [186] 0 0
Istanbul
Country [187] 0 0
Turkey
State/province [187] 0 0
Izmir
Country [188] 0 0
Ukraine
State/province [188] 0 0
Dnipro
Country [189] 0 0
Ukraine
State/province [189] 0 0
Kyiv
Country [190] 0 0
Ukraine
State/province [190] 0 0
Odesa
Country [191] 0 0
Ukraine
State/province [191] 0 0
Uzhgorod
Country [192] 0 0
United Kingdom
State/province [192] 0 0
Edinburgh
Country [193] 0 0
United Kingdom
State/province [193] 0 0
London
Country [194] 0 0
United Kingdom
State/province [194] 0 0
Nottingham
Country [195] 0 0
United Kingdom
State/province [195] 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 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.
Trial website
https://clinicaltrials.gov/show/NCT04538664
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/NCT04538664