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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/NCT05498428




Registration number
NCT05498428
Ethics application status
Date submitted
10/08/2022
Date registered
12/08/2022
Date last updated
11/10/2023

Titles & IDs
Public title
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Scientific title
A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients With Advanced or Metastatic Solid Tumors Including EGFR-mutated Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
2022-000526-21
Secondary ID [2] 0 0
CR109264
Universal Trial Number (UTN)
Trial acronym
PALOMA-2
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
Description of intervention(s) / exposure
Treatment: Drugs - Amivantamab
Treatment: Drugs - Lazertinib
Treatment: Drugs - Carboplatin
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Direct Oral Anticoagulant (DOAC)
Treatment: Drugs - Low Molecular Weight Heparin (LMWH)

Experimental: Cohort 1 (Exon19/L858R NSCLC, First Line, Previously Untreated): Amivantamab (Q2W) + Lazertinib - Participants with treatment-naive locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) exon 19 deletion (exon19del) or exon 21 leucine 858 to arginine substitution (exon 21 L858R) mutation, will receive amivantamab SC-CF injection, 1600 milligrams (mg) or 2240 mg if body weight is greater than or equal to (>=) 80 kilograms (kg), on Cycle 1 Days 1, 8, 15, and 22 and on Days 1 and 15 of each subsequent 28-day cycle, starting with Cycle 2, along with lazertinib 240 mg orally once daily.

Experimental: Cohort 2 (Exon20 NSCLC,1L, Previously Untreated): Amivantamab (Q3W) + Chemotherapy - Participants with treatment-naive locally advanced or metastatic NSCLC harboring an EGFR exon20ins mutation will receive Amivantamab SC-CF injection 1600 mg or 2240 mg if body weight is >=80 kg on Cycle 1 Day 1, 2400 mg or 3360 mg if body weight is >=80 kg on Cycle 1 Day 8 and 15 and on Day 1 of each subsequent 21-day cycle, starting with Cycle 2 along with pemetrexed 500 milligrams per meter square (mg/m^2) as intravenous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and IV infusion carboplatin area under the concentration-time curve 5 milligrams per milliliters (mg/mL) per minute (AUC 5) maximum 750 mg on Day 1 of each 21-day cycle, for up to 4 cycles.

Experimental: Cohort 3 (Exon19/L858R NSCLC, 2L, Post Osimertinib): Amivantamab (Q3W)+Lazertinib+Chemotherapy - Participants with locally advanced or metastatic NSCLC harboring an EGFR exon19del or exon 21 L858R mutation who have experienced disease progression on or after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (osimertinib), will receive amivantamab SC-CF injection 1600 mg or 2240 mg if body weight is >=80 kg on Cycle 1 Day 1, 2400 mg or 3360 mg if body weight is >=80 kg on Cycle 1 Day 8 and 15 and on Day 1 of each subsequent 21-day cycle starting with Cycle 2; in combination with IV infusion carboplatin area under the concentration-time curve 5 mg/mL per minute (AUC 5) maximum 750 mg on Day 1 of each 21-day cycle, for up to 4 cycles; and pemetrexed 500 mg/m^2 as an IV infusion (with vitamin supplementation) on Day 1 of each 21-day until disease progression. Lazertinib 240 mg orally once daily starting Cycle 5 Day 1 when carboplatin is complete or sooner if carboplatin discontinued earlier than Cycle 4.

Experimental: Cohort 4 (Previously Treated with Amivantamab IV): Switch from Amivantamab IV to SC-CF (Q2W) - Participants who were previously on amivantamab IV once every 2 weeks (Q2W) regimen as part of standard of care, for at least 8 weeks, either as monotherapy or combination with lazertinib, will receive amivantamab SC-CF injection 1600 mg and 2240 mg if body weight is greater than or equal to 80 kg.

Experimental: "Cohort 5 (Exon19/L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q4W) + Lazertinib - Participants with treatment-naïve locally advanced or metastatic NSCLC harboring an EGFR Exon19del or Exon 21 L858R mutation will receive amivantamab SC-CF induction with 1,600 mg (or 2,240 mg if BW >=80 kg) on Cycle 1 Days 1, 8, 15, and 22, starting with Cycle 2 on Day 1 of each next 28-day cycle, amivantamab SC-CF (160 mg/mL co-formulated with rHuPH20) by manual injection at 3,200 mg (or 4,320 mg if BW >=80 kg); along with lazertinib 240 mg by mouth once daily from Cycle 1 Day 1.

Experimental: "Cohort 6 (Exon19/L858R NSCLC,1L,Previously Untreated): Amivantamab (Q2W)+ Lazertinib+ Anticoagulant - Participants with treatment-naive locally advanced or metastatic NSCLC harboring an EGFR Exon19del or Exon 21 L858R mutation treated will receive will receive amivantamab SC-CF injection, 1600 milligrams (mg) and 2240 mg if body weight is greater than or equal to (>=) 80 kilograms (kg), on Cycle 1 Days 1, 8, 15, and 22 and on Days 1 and 15 of each subsequent 28-day cycle, starting with Cycle 2, along with lazertinib 240 mg orally once daily from Cycle 1 Day 1. Participants will additionally take prophylactic anticoagulation with a direct oral anticoagulant (DOAC) or a low molecular weight heparin (LMWH) for the first four months of study treatment (from Day 1 through Day 120) with the combination of amivantamab and lazertinib.


Treatment: Drugs: Amivantamab
Amivantamab will be administered subcutaneously by manual injection.

Treatment: Drugs: Lazertinib
Lazertinib will be administered as an oral tablet.

Treatment: Drugs: Carboplatin
Carboplatin will be administrated by IV infusion.

Treatment: Drugs: Pemetrexed
Pemetrexed will be administered by IV infusion.

Treatment: Drugs: Direct Oral Anticoagulant (DOAC)
DOAC will be administered orally.

Treatment: Drugs: Low Molecular Weight Heparin (LMWH)
LMWH will be administered subcutaneously.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All Cohorts Except Cohort 4: Objective Response Rate (ORR) Based on Investigator Assessment (INV)
Timepoint [1] 0 0
Up to 1 year 6 months
Primary outcome [2] 0 0
Cohort 4: Number of Participants with Adverse Events (AEs)
Timepoint [2] 0 0
Up to 1 year 6 months
Primary outcome [3] 0 0
Cohort 4: Number of Participants with AEs by Severity
Timepoint [3] 0 0
Up to 1 year 6 months
Primary outcome [4] 0 0
Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values
Timepoint [4] 0 0
Up to 1 year 6 months
Primary outcome [5] 0 0
Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values by Severity
Timepoint [5] 0 0
Up to 1 year 6 months
Secondary outcome [1] 0 0
All Cohorts Except Cohort 4: Number of Participants with AEs
Timepoint [1] 0 0
Up to 1 year 6 months
Secondary outcome [2] 0 0
All Cohorts Except Cohort 4: Number of Participants with AEs by Severity
Timepoint [2] 0 0
Up to 1 year 6 months
Secondary outcome [3] 0 0
All Cohorts Except Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values
Timepoint [3] 0 0
Up to 1 year 6 months
Secondary outcome [4] 0 0
All Cohorts Except Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values by Severity
Timepoint [4] 0 0
Up to 1 year 6 months
Secondary outcome [5] 0 0
All Cohorts Except Cohort 4: ORR Based on Independent Central Review (ICR)
Timepoint [5] 0 0
Up to 1 year 6 months
Secondary outcome [6] 0 0
All Cohorts Except Cohort 4: Duration of Response (DoR) Based on Investigator Assessment (INV)
Timepoint [6] 0 0
Up to 1 year 6 months
Secondary outcome [7] 0 0
All Cohorts Except Cohort 4: Time to Response (TTR) Based on INV
Timepoint [7] 0 0
Up to 1 year 6 months
Secondary outcome [8] 0 0
All Cohorts Except Cohort 4: Clinical Benefit Rate (CBR)
Timepoint [8] 0 0
Up to 1 year 6 months
Secondary outcome [9] 0 0
All Cohorts Except Cohort 4: Progression-free Survival (PFS)
Timepoint [9] 0 0
Up to 1 year 6 months
Secondary outcome [10] 0 0
All Cohorts Except Cohort 4: Overall Survival (OS)
Timepoint [10] 0 0
Up to 1 year 6 months
Secondary outcome [11] 0 0
All Cohorts Except Cohort 4: Number of Participants with Venous Thromboembolic Events (VTE)
Timepoint [11] 0 0
Up to 1 year 6 months
Secondary outcome [12] 0 0
All Cohorts Except Cohort 4: Number of Participants with Venous Thromboembolic Events (VTE) by Severity
Timepoint [12] 0 0
Up to 1 year 6 months
Secondary outcome [13] 0 0
All Cohorts Except Cohort 4: Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough) of Amivantamab
Timepoint [13] 0 0
Cycle 2 Day 1 of 28-day cycle
Secondary outcome [14] 0 0
Cohort 4: Cancer Therapy Satisfaction as Assessed by Modified Therapy Administration Satisfaction Questionnaire - Intravenous (TASQ-IV)
Timepoint [14] 0 0
Up to 1 year 6 months
Secondary outcome [15] 0 0
Cohort 4: Cancer Therapy Satisfaction as Assessed by Modified Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC)
Timepoint [15] 0 0
Up to 1 year 6 months
Secondary outcome [16] 0 0
Cohort 4: Patient-reported Status as Assessed by Patient Global Impression of Change (PGIC) Scale Score
Timepoint [16] 0 0
Up to 1 year 6 months
Secondary outcome [17] 0 0
Cohort 4: Patient-reported Status as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score
Timepoint [17] 0 0
Up to 1 year 6 months

Eligibility
Key inclusion criteria
- Participant must have histologically or cytologically confirmed, locally advanced or
metastatic, non-small cell lung cancer (NSCLC) that is not amenable to curative
therapy including surgical resection or chemoradiation. Additional Cohort specific
disease requirements include: Cohorts 1, 3, 5 and 6: epidermal growth factor receptor
(EGFR) exon 19 deletion (Exon19del) or Exon 21 L858R mutation; Cohort 2: EGFR Exon
20ins mutation EGFR Exon19del or Exon 21 L858R mutation (Cohort 1, 3, 5 and 6) or EGFR
Exon 20 insertion mutation (Cohort 2) must have been identified as determined by Food
and Drug Administration (FDA) approved or other validated test of either circulating
tumor deoxyribonucleic acid (ctDNA) or tumor tissue 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). A copy of the initial
test report documenting the EGFR mutation must be included in the participant records
and a deidentified copy must also be submitted to the sponsor

- Have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid
Tumors (RECIST) version 1.1. If the only target lesion has been previously irradiated,
it must show signs of disease progression since radiation was completed

- May have a prior or concurrent second malignancy (other than the disease under study)
which natural history or treatment is unlikely to interfere with any study endpoints
of safety or the efficacy of the study treatment(s)

- Have adequate organ (renal, hepatic, hematological, coagulation and cardiac) functions

- Participant must have eastern cooperative oncology group (ECOG) status of 0 or 1

- Cohort 6: Must be eligible for, and agree to comply with, the use of prophylactic
anticoagulation with a direct oral anticoagulant or a low molecular weight heparin
during the first 4 months of study treatment

- A female participant must agree not to donate eggs (ova, oocytes) or freeze for future
use for the purposes of assisted reproduction during the study and for a period of 6
months after receiving the last dose of study treatment. Female participants should
consider preservation of eggs prior to study treatment as anti-cancer treatments may
impair fertility
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participant has a medical history of interstitial lung disease (ILD), including drug
induced ILD or radiation pneumonitis

- Participant has a history of hypersensitivity to any excipients of the investigational
products to be used in their enrollment cohort

- Participant has received a live or live attenuated vaccine within 3 months before
Cycle 1 Day 1. The seasonal influenza vaccine and non-live vaccines against
Coronavirus disease 19 (COVID-19) are not exclusionary

- For all cohorts (regimens potentially including lazertinib) except cohort 2:
Participant is currently receiving medications or herbal supplements known to be
potent Cytochrome (CYP3A4/5) inducers and is unable to stop use for an appropriate
washout period prior to Cycle 1 Day 1

- Other clinically active liver disease of infectious origin

- Participant has a history of clinically significant cardiovascular disease including,
but not limited to: a) All cohorts: diagnosis of deep vein thrombosis or pulmonary
embolism within 1 month prior to the first dose of study treatment(s), or any of the
following within 6 months prior to the first dose of study treatment(s): myocardial
infarction, unstable angina, stroke, transient ischemic attack, coronary/peripheral
artery bypass graft, or any acute coronary syndrome. Clinically non-significant
thrombosis, such as non-obstructive catheter-associated clots, are not exclusionary;
b) All cohorts (regimens potentially including lazertinib) except Cohort 2:
Participant has a significant genetic predisposition to venous thromboembolic events
(VTE; such as Factor V Leiden); c) All cohorts (regimens potentially including
lazertinib) except Cohort 2: Participant has a prior history of VTE and is not on
appropriate therapeutic anticoagulation as per NCCN or local guidelines; d) prolonged
corrected QT interval by Fridericia (QTcF) interval greater than (>) 480 milliseconds
(msec) or clinically significant cardiac arrhythmia or electrophysiologic disease
(example, placement of implantable cardioverter defibrillator or atrial fibrillation
with uncontrolled rate); e) uncontrolled (persistent) hypertension: systolic blood
pressure >160 millimeter(s) of mercury (mmHg); diastolic blood pressure >100 mmHg; f)
Congestive heart failure defined as NYHA class III-IV or hospitalization for
congestive heart failure (CHF) (any New York Heart Association [NYHA] class) within 6
months of treatment initiation at Cycle 1/day 1 (C1D1); g) pericarditis/clinically
significant pericardial effusion; h) myocarditis; i) baseline left ventricular
ejection fraction (LVEF) below the institution's lower limit of normal at screening,
as assessed by echocardiogram or multigated acquisition (MUGA) scan

- Participant has symptomatic brain metastases. A participant with asymptomatic or
previously treated and stable brain metastases may participate in this study.
Participants who have received definitive radiation or surgical treatment for
symptomatic or unstable brain metastases and have been clinically stable and
asymptomatic for at least 2 weeks before Screening are eligible, provided they have
been either off corticosteroid treatment or are receiving low-dose corticosteroid
treatment (less than or equal to [<=] 10 milligrams per day [mg/day] prednisone or
equivalent) for at least 2 weeks prior to treatment allocation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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 2
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
11/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/01/2025
Actual
Sample size
Target
390
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Brazil
State/province [12] 0 0
Barretos
Country [13] 0 0
Brazil
State/province [13] 0 0
Belo Horizonte
Country [14] 0 0
Brazil
State/province [14] 0 0
Londrina
Country [15] 0 0
Brazil
State/province [15] 0 0
Porto Alegre
Country [16] 0 0
Brazil
State/province [16] 0 0
Rio de Janeiro
Country [17] 0 0
Brazil
State/province [17] 0 0
Salvador
Country [18] 0 0
Brazil
State/province [18] 0 0
Sao Paulo
Country [19] 0 0
Brazil
State/province [19] 0 0
São Paulo
Country [20] 0 0
China
State/province [20] 0 0
Baoding
Country [21] 0 0
China
State/province [21] 0 0
Changchun
Country [22] 0 0
China
State/province [22] 0 0
Chengdu
Country [23] 0 0
China
State/province [23] 0 0
ChongQing
Country [24] 0 0
China
State/province [24] 0 0
Guangzhou
Country [25] 0 0
China
State/province [25] 0 0
Hangzhou
Country [26] 0 0
China
State/province [26] 0 0
Harbin
Country [27] 0 0
China
State/province [27] 0 0
Huizhou
Country [28] 0 0
China
State/province [28] 0 0
Liuzhou
Country [29] 0 0
China
State/province [29] 0 0
Shanghai
Country [30] 0 0
China
State/province [30] 0 0
Tianjin
Country [31] 0 0
China
State/province [31] 0 0
Wenzhou
Country [32] 0 0
China
State/province [32] 0 0
Wuhan
Country [33] 0 0
China
State/province [33] 0 0
Wuxi
Country [34] 0 0
China
State/province [34] 0 0
Xi'an
Country [35] 0 0
China
State/province [35] 0 0
Yantai
Country [36] 0 0
France
State/province [36] 0 0
Caen Cedex 05
Country [37] 0 0
France
State/province [37] 0 0
Dijon
Country [38] 0 0
France
State/province [38] 0 0
Nîmes
Country [39] 0 0
France
State/province [39] 0 0
PARIS Cedex 5
Country [40] 0 0
France
State/province [40] 0 0
Saint-Herblain Cedex
Country [41] 0 0
France
State/province [41] 0 0
Villejuif Cedex
Country [42] 0 0
Germany
State/province [42] 0 0
Berlin
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Germany
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Grosshandorf
Country [44] 0 0
Germany
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Immenhausen
Country [45] 0 0
Germany
State/province [45] 0 0
Koeln
Country [46] 0 0
Germany
State/province [46] 0 0
Wuerzburg
Country [47] 0 0
Israel
State/province [47] 0 0
Haifa
Country [48] 0 0
Israel
State/province [48] 0 0
Jerusalem
Country [49] 0 0
Israel
State/province [49] 0 0
Kfar Saba
Country [50] 0 0
Israel
State/province [50] 0 0
Petah Tikva
Country [51] 0 0
Israel
State/province [51] 0 0
Ramat Gan
Country [52] 0 0
Italy
State/province [52] 0 0
Genova
Country [53] 0 0
Italy
State/province [53] 0 0
Milano
Country [54] 0 0
Italy
State/province [54] 0 0
Monza
Country [55] 0 0
Italy
State/province [55] 0 0
Naples
Country [56] 0 0
Japan
State/province [56] 0 0
Himeji
Country [57] 0 0
Japan
State/province [57] 0 0
Matsusaka
Country [58] 0 0
Japan
State/province [58] 0 0
Niigata
Country [59] 0 0
Japan
State/province [59] 0 0
Shizuoka
Country [60] 0 0
Japan
State/province [60] 0 0
Tokyo
Country [61] 0 0
Japan
State/province [61] 0 0
Wakayama
Country [62] 0 0
Korea, Republic of
State/province [62] 0 0
Goyang-Si
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Gyeonggi-do
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Seoul
Country [65] 0 0
Malaysia
State/province [65] 0 0
Kuala Lumpur
Country [66] 0 0
Malaysia
State/province [66] 0 0
Kuantan
Country [67] 0 0
Malaysia
State/province [67] 0 0
Kuching
Country [68] 0 0
Malaysia
State/province [68] 0 0
Petaling Jaya
Country [69] 0 0
Spain
State/province [69] 0 0
A Coruña
Country [70] 0 0
Spain
State/province [70] 0 0
Alacant
Country [71] 0 0
Spain
State/province [71] 0 0
Barcelona
Country [72] 0 0
Spain
State/province [72] 0 0
Madrid
Country [73] 0 0
Spain
State/province [73] 0 0
Malaga
Country [74] 0 0
Spain
State/province [74] 0 0
Sevilla
Country [75] 0 0
Spain
State/province [75] 0 0
Valencia
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Cheltenham
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Devon
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Edinburgh
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Leicester
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United Kingdom
State/province [80] 0 0
London
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United Kingdom
State/province [81] 0 0
Nottingham
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United Kingdom
State/province [82] 0 0
Portsmouth

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 assess the anti-tumor activity and safety of amivantamab
which will be administered as a co-formulation with recombinant human hyaluronidase PH20
(rHuPH20) (subcutaneous co-formulation [SC-CF]) in combination treatment (all cohorts except
Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05498428
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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
Participate-In-This-Study@its.jnj.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05498428