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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05388669




Registration number
NCT05388669
Ethics application status
Date submitted
19/05/2022
Date registered
24/05/2022

Titles & IDs
Public title
A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer
Scientific title
A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy
Secondary ID [1] 0 0
2022-000525-25
Secondary ID [2] 0 0
CR109211
Universal Trial Number (UTN)
Trial acronym
PALOMA-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Lazertinib
Treatment: Drugs - Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
Treatment: Drugs - Amivantamab Intravenous

Experimental: Arm A: Lazertinib with Amivantamab SC-CF - Lazertinib 240 milligrams (mg) will be administered orally once daily. Participants will receive amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), 1600 mg/ 2240 mg depending on the body weight by manual injection. Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment within the study by transferring to the long-term extension (LTE) Phase.

Experimental: Arm B: Lazertinib with Amivantamab Intravenous (IV) Infusion - Lazertinib 240 mg will be administered orally once. Participants will receive amivantamab, 1050 mg or 1400 mg depending on the body weight as an IV infusion. Participants benefiting from study treatment after primary analysis may continue to receive access to study treatment within the study by transferring to the LTE Phase.


Treatment: Drugs: Lazertinib
Lazertinib tablets will be administered orally.

Treatment: Drugs: Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)
Amivantamab injection will be administered subcutaneously by manual injection.

Treatment: Drugs: Amivantamab Intravenous
Amivantamab will be administered by IV infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
For All Regions Other Than the European Union (EU) and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State on Cycle 4 Day 1
Timepoint [1] 0 0
Cycle 4 Day 1 (28 days cycle)
Primary outcome [2] 0 0
For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab at Pre-dose on Cycle 2 Day 1
Timepoint [2] 0 0
Cycle 2 Day 1 (28 days cycle)
Primary outcome [3] 0 0
Area Under the Concentration Time Curve from Day 1 to Day 15 (AUC[Day 1-15]) of Amivantamab of Cycle 2
Timepoint [3] 0 0
Cycle 2 Day 1 to Cycle 2 Day 15 (28 days cycle)
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to 1 year 11 months
Secondary outcome [2] 0 0
Progression-Free Survival (PFS)
Timepoint [2] 0 0
Up to 1 year 11 months
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
Up to 1 year 11 months
Secondary outcome [4] 0 0
Time to Response (TTR)
Timepoint [4] 0 0
Up to 1 year 11 months
Secondary outcome [5] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [5] 0 0
Up to 4 year 11 months
Secondary outcome [6] 0 0
Number of Participants with AEs by Severity
Timepoint [6] 0 0
Up to 4 year 11 months
Secondary outcome [7] 0 0
Number of Participants with Clinical Laboratory Abnormalities
Timepoint [7] 0 0
Up to 4 year 11 months
Secondary outcome [8] 0 0
Number of Participants with Clinical Laboratory Abnormalities by Severity
Timepoint [8] 0 0
Up to 4 year 11 months
Secondary outcome [9] 0 0
Number of Participants Infusion Related Reactions (IRRs)
Timepoint [9] 0 0
Up to 1 year 11 months
Secondary outcome [10] 0 0
Number of Participants with Infusion Related Reactions (IRRs) by Severity
Timepoint [10] 0 0
Up to 1 year 11 months
Secondary outcome [11] 0 0
For All Regions Other Than the EU and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Pre-dose on Cycle 2 Day 1
Timepoint [11] 0 0
Cycle 2 Day 1 (28 days cycle)
Secondary outcome [12] 0 0
For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State on Cycle 4 Day 1
Timepoint [12] 0 0
Cycle 4 Day 1 (28 days cycle)
Secondary outcome [13] 0 0
Model-Predicted Area Under the Concentration Time Curve from Day 1 to Day 15 (AUC[Day 1-15]) of Amivantamab at Steady State of Cycle 4
Timepoint [13] 0 0
From Cycle 4 Day 1 to Cycle 4 Day 15 (28 days cycle)
Secondary outcome [14] 0 0
Percentage of Participants with Presence of Anti-amivantamab Antibodies and Anti-rHuPH20 Antibodies
Timepoint [14] 0 0
Up to 1 year 11 months
Secondary outcome [15] 0 0
Percentage of Participants with Cancer Therapy Satisfaction as Assessed by Therapy Administration Satisfaction Questionnaire (TASQ)
Timepoint [15] 0 0
Up to 1 year 11 months
Secondary outcome [16] 0 0
Change from Baseline in TASQ as Assessed Over Time
Timepoint [16] 0 0
Up to 1 year 11 months
Secondary outcome [17] 0 0
Participant Chair Time
Timepoint [17] 0 0
Up to 1 year 11 months
Secondary outcome [18] 0 0
Duration of Treatment Administration
Timepoint [18] 0 0
Up to 1 year 11 months
Secondary outcome [19] 0 0
Active HCP Time For Drug Preparation, Treatment Administration and Posttreatment Monitoring
Timepoint [19] 0 0
Up to 1 year 11 months
Secondary outcome [20] 0 0
Participant Time in Treatment Room
Timepoint [20] 0 0
Up to 1 year 11 months

Eligibility
Key inclusion criteria
* Have histologically or cytologically confirmed, advanced or metastatic non-small cell lung cancer (NSCLC), characterized by either epidermal growth factor receptor (EGFR) Exon 19 deletion (Exon 19del) or Exon 21 leucine 858 to arginine substitution (Exon 21 L858R) mutation by an 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 Started [US]) or an accredited local laboratory (sites outside of the US)
* Have progressed on or after osimertinib (or another approved 3rd generation epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor [TKI]) and platinum-based chemotherapy (irrespective of order). a) The 3rd generation EGFR TKI must have been administered as the first EGFR TKI for metastatic disease or as the second TKI after prior treatment with first- or second-generation EGFR TKI in participants with metastatic EGFR T790M mutation positive NSCLC. b) Participants who decline or are otherwise ineligible for chemotherapy may be enrolled after discussion with the medical monitor. c) Any adjuvant or neoadjuvant treatment, whether with a 3rd generation EGFR TKI or platinum based chemotherapy, would count towards the prior treatment requirement if the participant experienced disease
* Have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) version 1.1
* Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
* Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia [any grade], Grade less than or equal to (<=) 2 peripheral neuropathy, and Grade <=2 hypothyroidism stable on hormone replacement)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participant has received cytotoxic, investigational, or targeted therapies beyond one regimen of platinum-based chemotherapy and EGFR inhibitors
* Participant has received radiotherapy for palliative purposes less than 7 days prior to randomization
* Participant has symptomatic or progressive brain metastases
* Participant has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation
* Participant has uncontrolled tumor-related pain
* Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis

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
5/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
Accrual to date
Final
418
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cancer Research SA - Adelaide
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [4] 0 0
St John of God Hospital Murdoch - Murdoch
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
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
Colorado
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
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
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Oregon
Country [9] 0 0
United States of America
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Pennsylvania
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United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
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Argentina
State/province [12] 0 0
Buenos Aires
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Argentina
State/province [13] 0 0
Caba
Country [14] 0 0
Argentina
State/province [14] 0 0
Ciudad Autonoma de Buenos Aires
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Argentina
State/province [15] 0 0
Cordoba
Country [16] 0 0
Argentina
State/province [16] 0 0
Viedma
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Brazil
State/province [17] 0 0
Barretos
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Brazil
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Belo Horizonte
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Brazil
State/province [19] 0 0
Curitiba
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Brazil
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Florianopolis
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Brazil
State/province [21] 0 0
Ipatinga
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Brazil
State/province [22] 0 0
Pelotas
Country [23] 0 0
Brazil
State/province [23] 0 0
Porto Alegre
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Brazil
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Rio de Janeiro
Country [25] 0 0
Brazil
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Salvador
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Brazil
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Santo Andre
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Brazil
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Sao Paulo
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Brazil
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São Paulo
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Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
China
State/province [30] 0 0
Beijing
Country [31] 0 0
China
State/province [31] 0 0
Changchun
Country [32] 0 0
China
State/province [32] 0 0
Changzhou
Country [33] 0 0
China
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Chengdu
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China
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Chongqing
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China
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ChongQing
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China
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Ganzhou
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China
State/province [37] 0 0
Guang Zhou
Country [38] 0 0
China
State/province [38] 0 0
Guangzhou
Country [39] 0 0
China
State/province [39] 0 0
Hang Zhou
Country [40] 0 0
China
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Hangzhou
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China
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Harbin
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China
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Huizhou
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China
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Liuzhou
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China
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Nanchong
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China
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Shanghai
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China
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Shen Zhen Shi
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China
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Shenyang
Country [48] 0 0
China
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Shenzhen
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China
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Tianjin
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China
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Wuhan
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China
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XI An
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China
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Xiangyang
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China
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Yantai
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China
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Zhengzhou
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France
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La Tronche
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France
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Lille
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France
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Limoges
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Marseille Cedex 20
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Germany
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Berlin
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Germany
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Georgsmarienhütte
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Germany
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Giessen
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Germany
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Münster
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Germany
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Recklinghausen
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Germany
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Weinsberg
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Petah-Tikva
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Israel
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Ramat Gan
Country [70] 0 0
Italy
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Bari
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Italy
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Bologna
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Italy
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Milano
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Italy
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Orbassano
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Italy
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Padova
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Italy
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Ravenna
Country [76] 0 0
Italy
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Roma
Country [77] 0 0
Italy
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Rome
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Italy
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Rozzano
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Japan
State/province [79] 0 0
Chuo Ku
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Japan
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Himeji
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Japan
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Hirakata
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Japan
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Kanagawa
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Japan
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Kurashiki
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Japan
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Kurume
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Japan
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Matsusaka
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Japan
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Niigata
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Japan
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Okayama
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Japan
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Osaka City
Country [89] 0 0
Japan
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Sapporo-shi
Country [90] 0 0
Japan
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Shizuoka
Country [91] 0 0
Japan
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Tokyo
Country [92] 0 0
Japan
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Toyoake
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Japan
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Toyonaka-shi
Country [94] 0 0
Japan
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Wakayama
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Japan
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Yamaguchi
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
State/province [97] 0 0
Gyeongsangnam-do
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Korea, Republic of
State/province [98] 0 0
Jeollanam-do
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Korea, Republic of
State/province [99] 0 0
Seongnam-si
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Korea, Republic of
State/province [100] 0 0
Seoul
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuching
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Malaysia
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Petaling Jaya
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Poland
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Bydgoszcz
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Poland
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Krakow
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Poland
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Otwock
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Poland
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Poznan
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Poland
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Warszawa
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Portugal
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Braga
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Portugal
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Lisboa
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Portugal
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Senhora da Hora
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Spain
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A Coruna
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Córdoba
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Spain
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Las Palmas de Gran Canaria
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Spain
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Lugo
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Spain
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Madrid
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Spain
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Majadahonda
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Spain
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Málaga
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Spain
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Oviedo
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Spain
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Palma de Mallorca
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Spain
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Sevilla
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Spain
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Valencia
Country [125] 0 0
Taiwan
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Changhua
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Taiwan
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Kaohsiung City
Country [127] 0 0
Taiwan
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Kaohsiung
Country [128] 0 0
Taiwan
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Taichung
Country [129] 0 0
Taiwan
State/province [129] 0 0
Tainan
Country [130] 0 0
Taiwan
State/province [130] 0 0
Taipei City
Country [131] 0 0
Taiwan
State/province [131] 0 0
Taipei
Country [132] 0 0
Taiwan
State/province [132] 0 0
Taoyuan
Country [133] 0 0
Thailand
State/province [133] 0 0
Bangkok
Country [134] 0 0
Thailand
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Chiangmai
Country [135] 0 0
Turkey
State/province [135] 0 0
Adana
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Turkey
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Ankara
Country [137] 0 0
Turkey
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Edirne
Country [138] 0 0
Turkey
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Istanbul
Country [139] 0 0
Turkey
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Izmir
Country [140] 0 0
Turkey
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Samsun
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Birmingham
Country [142] 0 0
United Kingdom
State/province [142] 0 0
London
Country [143] 0 0
United Kingdom
State/province [143] 0 0
Newcastle Upon Tyne
Country [144] 0 0
United Kingdom
State/province [144] 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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05388669