Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04538664




Registration number
NCT04538664
Ethics application status
Date submitted
31/08/2020
Date registered
4/09/2020
Date last updated
29/05/2024

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
Treatment: Drugs - Pemetrexed

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. Following the primary analysis for efficacy, the study will transition to an OLE phase and participants will continue to receive the amivantamab plus chemotherapy in OLE phase. Participants who completed OLE period will enter LTE period and continue to receive same treatment.

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. Following the primary analysis for efficacy, the study will transition to an OLE phase and participants will either continue to receive the chemotherapy or cross over to amivantamab in OLE phase. Participants who completed OLE period will enter LTE period and continue to receive same treatment.


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 and will continue the same treatment in OLE phase then in LTE phase.

Treatment: Drugs: Pemetrexed
Pemetrexed will be administered 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 Arm A and will continue the same treatment in OLE phase then in LTE phase.

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

Treatment: Drugs: Pemetrexed
Pemetrexed will be administered 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 Arm B and will continue the same treatment in OLE phase then in LTE phase.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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)
Timepoint [1] 0 0
From randomization to either disease progression or death whichever occurs first (up to 29 months)
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to 5 years 3 months
Secondary outcome [2] 0 0
Duration of Response (DoR)
Timepoint [2] 0 0
Up to 5 years 3 months
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Up to 5 years 3 months
Secondary outcome [4] 0 0
Time to Subsequent Therapy (TST)
Timepoint [4] 0 0
Up to 5 years 3 months
Secondary outcome [5] 0 0
Progression-Free Survival After First Subsequent Therapy (PFS2)
Timepoint [5] 0 0
Up to 5 years 3 months
Secondary outcome [6] 0 0
Time to Symptomatic Progression (TTSP)
Timepoint [6] 0 0
Up to 5 years 3 months
Secondary outcome [7] 0 0
Number of Participants Treatment-emergent Adverse Events (TEAEs)
Timepoint [7] 0 0
From Day 1 to 5 years 2 months
Secondary outcome [8] 0 0
Number of Participants TEAEs With Severity
Timepoint [8] 0 0
From Day 1 to 5 years 2 months
Secondary outcome [9] 0 0
Number of Participants With Clinical Laboratory Abnormalities
Timepoint [9] 0 0
Up to 5 years 3 months
Secondary outcome [10] 0 0
Number of Participants With Vital Signs Abnormalities
Timepoint [10] 0 0
Up to 5 years 3 months
Secondary outcome [11] 0 0
Number of Participants With Physical Examination Abnormalities
Timepoint [11] 0 0
Up to 5 years 3 months
Secondary outcome [12] 0 0
Serum Concentration of Amivantamab
Timepoint [12] 0 0
Day 1 (Cycles 1, 2, 3, 5, 7, 9, 11, 13), Day 2 (Cycle 1)
Secondary outcome [13] 0 0
Number of Participants With Anti-Amivantamab Antibodies
Timepoint [13] 0 0
Day 1 (Cycles 1, 2, 3, 5, 7, 9, 11, 13), Day 2 (Cycle 1)
Secondary outcome [14] 0 0
Change From Baseline in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Timepoint [14] 0 0
From baseline to 5 years 3 months
Secondary outcome [15] 0 0
Change From Baseline in Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF)
Timepoint [15] 0 0
From baseline to 5 years 3 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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participant has evidence of synchronous NSCLC disease (as suggested by genetic
characterization or radiographic appearance)

- 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
Accrual to date
Final
308
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
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Cabrini Medical Centre - Malvern
Recruitment hospital [4] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
3144 - Malvern
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
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New Taipei
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Bangkok
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Edirne
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Istanbul
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Izmir
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Ukraine
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Dnipro
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Kyiv
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Edinburgh
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London
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United Kingdom
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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 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/ct2/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04538664