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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02609776




Registration number
NCT02609776
Ethics application status
Date submitted
18/11/2015
Date registered
20/11/2015
Date last updated
6/12/2024

Titles & IDs
Public title
Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer
Scientific title
A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Subjects With Advanced Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
61186372EDI1001
Secondary ID [2] 0 0
CR108064
Universal Trial Number (UTN)
Trial acronym
CHRYSALIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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
Description of intervention(s) / exposure
Treatment: Drugs - Amivantamab
Treatment: Drugs - Amivantamab
Treatment: Drugs - Lazertinib
Treatment: Drugs - Carboplatin
Treatment: Drugs - Pemetrexed

Experimental: Part 1:Amivantamab Monotherapy+Combination Dose Escalations - The first cohort of participants will receive intravenous (IV) infusions of Amivantamab 140 milligram (mg) as monotherapy. Each subsequent cohort will receive IV infusions of Amivantamab at increased dose level. Dose escalation will continue until maximum tolerated dose is reached or all planned doses are administered. Participants will receive IV infusion of Amivantamab once weekly during cycle 1 and once every 2 weeks during subsequent cycles (duration of each treatment cycle is 28 days). Participants will receive lazertinib and Amivantamab on Cycle 1 Day 1 (C1D1) prior to initiation of Amivantamab (C1D1) at predefined dose levels, based upon observed safety and protocol defined criteria. Lazertinib will be administered daily thereafter, on 28-day Amivantamab treatment cycle. In Chemotherapy Combination Cohort, participants will receive Amivantamab, administered on a 21-day cycle, in combination with standard of care carboplatin and pemetrexed.

Experimental: Part 2:Amivantamab Monotherapy+Combination Dose Expansion - Participants will receive IV infusion of Amivantamab as monotherapy at Phase 2 dose (RP2D) regimen or in combination lazertinib at the recommended Phase 2 combination dose (RP2CD) regimen as determined in Part 1. The purpose of dose expansion is to further evaluate safety, tolerability, pharmacokinetic, and to assess preliminary efficacy in monotherapy and combination therapy cohorts.


Treatment: Drugs: Amivantamab
The first cohort of participants will receive IV infusions of Amivantamab 140 mg as monotherapy. Each subsequent cohort will receive IV infusions of Amivantamab at increased dose level until maximum tolerated dose is reached or all planned doses are administered. Participants will receive lazertinib and Amivantamab at predefined dose levels, based upon observed safety and protocol defined criteria. The duration of each treatment cycle is 28 days. In Chemotherapy Combination Cohort, participants will receive Amivantamab, administered on a 21-day cycle, in combination with the administration of standard of care carboplatin and pemetrexed.

Treatment: Drugs: Amivantamab
Participants will receive IV infusion of Amivantamab as monotherapy at RP2D regimen or in combination lazertinib at RP2CD regimen as determined in Part 1.

Treatment: Drugs: Lazertinib
Lazertinib will be administered in combination with Amivantamab at predefined dose levels, based upon observed safety and protocol defined criteria. Lazertinib will be administered daily on the 28-day Amivantamab treatment cycle.

Treatment: Drugs: Carboplatin
Participants will receive carboplatin in combination with pemetrexed and Amivantamab as an IV infusion on 21-day treatment cycle in Part 1 Chemotherapy Combination Cohort only.

Treatment: Drugs: Pemetrexed
Participants will receive pemetrexed in combination with carboplatin and Amivantamab as an IV infusion on 21-day treatment cycle in Part 1 Chemotherapy Combination Cohort only.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
Timepoint [1] 0 0
Up to Day 28
Primary outcome [2] 0 0
Part 2: Number of Participants With Adverse Events (AEs) and Serious AEs
Timepoint [2] 0 0
Screening up to follow-up (30 [+7] days after the last dose)
Primary outcome [3] 0 0
Part 2: Overall Response Rate (ORR)
Timepoint [3] 0 0
Up to End of Treatment Follow (EOT) Up Period (30 [+7] days after the last dose)
Primary outcome [4] 0 0
Part 2: Duration of Response (DOR)
Timepoint [4] 0 0
Up to EOT Follow Up Period (30 [+7] days after the last dose)
Primary outcome [5] 0 0
Part 2: Percentage of Participants With Clinical Benefit
Timepoint [5] 0 0
Up to EOT Follow Up Period (30 [+7] days after the last dose)
Primary outcome [6] 0 0
Trough Serum Concentration (Ctrough) of Amivantamab
Timepoint [6] 0 0
Up to EOT (30 days after last dose)
Primary outcome [7] 0 0
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Amivantamab
Timepoint [7] 0 0
Up to EOT (30 days after last dose)
Secondary outcome [1] 0 0
Maximum Serum Concentration (Cmax) of Amivantamab
Timepoint [1] 0 0
Cycle 1 Day 1: predose through end of infusion (EOT) or Follow Up (approximately 16 months) (each cycle is of 28 days)
Secondary outcome [2] 0 0
Time to Reach Maximum Observed Serum Concentration (Tmax) of Amivantamab
Timepoint [2] 0 0
Cycle 1 Day 1: predose through EOT or Follow Up (approximately 16 months)
Secondary outcome [3] 0 0
Area Under the Serum Concentration-Time Curve From t1 to t2 Time (AUC[t1-t2]) of Amivantamab
Timepoint [3] 0 0
Cycle 1 Day 1: predose through EOT or Follow Up (approximately 16 months)
Secondary outcome [4] 0 0
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Amivantamab
Timepoint [4] 0 0
Cycle 1 Day 1: predose through EOT or Follow Up (approximately 16 months)
Secondary outcome [5] 0 0
Trough Serum Concentration (Ctrough) of Amivantamab
Timepoint [5] 0 0
Cycle 1 Day 1: predose through EOT or Follow Up (approximately 16 months)
Secondary outcome [6] 0 0
Maximum Serum Concentration (Cmax) of Lazertinib
Timepoint [6] 0 0
Cycle 1 Day 1: predose through EOT (30 [+7] days after last dose [Cycle 4 Day 15]) (each cycle is of 28 days)
Secondary outcome [7] 0 0
Time to Reach Maximum Observed Serum Concentration (Tmax) of Lazertinib
Timepoint [7] 0 0
Cycle 1 Day 1: predose through EOT (30 [+7] days after last dose [Cycle 4 Day 15]) (each cycle is of 28 days)
Secondary outcome [8] 0 0
Trough Serum Concentration (Ctrough) of Lazertinib
Timepoint [8] 0 0
Cycle 1 Day 1: predose through EOT (30 [+7] days after last dose [Cycle 4 Day 15]) (each cycle is of 28 days)
Secondary outcome [9] 0 0
Accumulation ratio (R) of Amivantamab
Timepoint [9] 0 0
Cycle 1 Day 1: predose through EOT or Follow Up (approximately 16 months)
Secondary outcome [10] 0 0
Number of Participants With Anti-Drug Antibodies (ADA)
Timepoint [10] 0 0
Cycle 1 Day 1: predose through EOT or Follow Up (approximately 16 months)
Secondary outcome [11] 0 0
Progression-Free Survival (PFS)
Timepoint [11] 0 0
Up to End of Treatment Follow Up Period (30 [+7] days after the last dose)
Secondary outcome [12] 0 0
Time to Treatment Failure (TTF)
Timepoint [12] 0 0
Up to End of Treatment Follow Up Period (30 [+7] days after the last dose)
Secondary outcome [13] 0 0
Overall Survival (OS)
Timepoint [13] 0 0
Up to End of Treatment Follow Up Period (30 [+7] days after the last dose)

Eligibility
Key inclusion criteria
* Participant must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) that is metastatic or unresectable. Participants must have either progressed after prior standard of care therapy (Cohorts C and hepatocyte growth factor receptor gene [MET]-1: epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor [TKI]; Cohort D: platinum-based chemotherapy; MET-2: per regional standard of care; Cohorts wild-type adenocarcinoma (WT-Ad) and wild-type squamous cell carcinoma (WT-Sq): platinum-containing chemotherapy and programmed death- 1/ ligand-1 (PD-1/L1) therapy, either as a combined regimen or as separate lines of therapy) for metastatic disease, or be ineligible for, or have refused all other currently available therapeutic options. In cases where participants refuse currently available therapeutic options, this must be documented in the study records. For Part 1 Chemotherapy Combination Cohort only: Participants must have histologically or cytologically confirmed NSCLC that is metastatic or unresectable and be eligible for treatment with combination carboplatin and pemetrexed, in accordance with standard of care, and be willing to receive additional investigational therapy with Amivantamab
* For Part 1 Combination Dose Escalation with lazertinib only: Participants must have been diagnosed with EGFR Exon 19del or L858R activating mutation and (a) be treatment naïve for metastatic disease, without access to third generation TKI in the front-line setting, or (b) have progressed after front-line treatment with first (erlotinib or gefitinib) or second generation (afatinib) TKI and are ineligible for Cohort MET-1, or (c) have been treated with a third generation TKI (e.g., osimertinib) in either the front line or second-line setting, and are not eligible for enrollment in either Cohort C or MET-1. For Part 1 Chemotherapy Combination Cohort: Participants may be diagnosed with EGFR mutated or EGFR wild type NSCLC. For Part 2 Cohorts C, D, MET-1, and MET-2 only: Participants must also have disease with a previously diagnosed activating epidermal growth factor receptor (EGFR) mutation (includes both inhibitor sensitive primary mutations such as Exon 19 deletion and L858R (Cohort C, E, and MET-1), as well as marketed TKI-resistant mutations such as Exon 20 insertion (Cohort C, D and MET-1) or activating cMet Exon 14 skipping mutation (Cohort MET-2). Documentation of primary activating EGFR or cMet mutation eligibility by CLIA-certified laboratory (or equivalent) testing is required. For Part 2 Cohorts WT-Ad and WT-Sq: Participants must have wild-type EGFR, anaplastic lymphoma kinase (ALK), and absence of MET Exon 14 skipping mutation as tested by the Food and Drug Administration (FDA) approved test or a CLIA-certified laboratory (or equivalent). The pathology report or equivalent must be in the medical record for verification. Where testing for EGFR and ALK are not part of standard of care for participants with squamous cell carcinoma histology, documentation of the absence of these mutations is not necessary for enrollment into the WT-Sq cohort
* For Part 1: Participant must have evaluable disease. For Part 2: Participant must have measurable disease according to Response Criteria in Solid Tumors (RECIST) v1.1
* For Part 2: Cohorts A and B: Participants EGFR mutated disease must have most recently progressed following treatment with a marketed EGFR inhibitor. Exception: In participants diagnosed with mutations associated with de novo EGFR inhibitor resistance (for example, Exon 20 insertions), only previous treatment with combination platinum-based chemotherapy is required. Cohort C: Participants with primary EGFR mutated disease, with a documented EGFR alteration (example, C797S) mediating resistance to previous treatment with a third generation EGFR TKI (for example, osimertinib), in participants with primary Exon 20ins disease, the documented EGFR alteration may arise following treatment with a TKI with known activity against Exon 20ins disease (for example, poziotinib). Cohort D: participants must have been previously diagnosed with an EGFR Exon 20 insertion and have not been previously treated with a TKI with known activity against Exon 20ins disease (example, poziotinib). Cohort MET-1: Participants with documented primary EGFR mutated disease and documented MET amplification or MET mutation after progression on any EGFR TKI. Participants with disease characterized by both MET amplification and EGFR resistance mutations to prior third generation EGFR TKI will be preferentially enrolled into Cohort C. Participants may have received or have been intolerant to prior platinum-based chemotherapy. Cohort MET-2: Participants with documented primary MET Exon 14 skipping mutation non-small cell lung cancer (NSCLC). Cohort E (combination Amivantamab and lazertinib): Participants must have been diagnosed with EGFR Exon 19del or L858R activating mutation and have progressed after first or second-line treatment with a third generation TKI (e.g., osimertinib). Cohort WT-Ad: Participant must have been diagnosed with NSCLC of adenocarcinoma histology, with positive EGFR and/or MET expression as detected on a validated immunohistochemistry (IHC) assay performed by the central laboratory and have progressed on prior platinum containing chemotherapy and PD-1/L1 therapy, either as a combined regimen or as a separate line of therapy. Eligibility may be determined through IHC analysis of either archival (pre-screening) or mandatory fresh tumor tissue collected during the Screening period. Cohort WT-Sq: Participant must have been diagnosed with NSCLC of squamous cell carcinoma histology, with positive EGFR and/or MET expression as detected on a validated IHC assay performed by the central laboratory and have progressed on prior platinum-containing chemotherapy and PD-1/L1 therapy, either as a combined regimen or as a separate line of therapy. Eligibility may be determined through IHC analysis of either archival (pre-screening) or mandatory fresh tumor tissue collected during the Screening
* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participant has uncontrolled inter-current illness, including but not limited to poorly controlled hypertension, or diabetes, ongoing or active infection, (that is, has discontinued all antibiotics for at least one week prior to first dose of study drug), or psychiatric illness/social situation that would limit compliance with study requirements. Participants with medical conditions requiring chronic continuous oxygen therapy are excluded. For Part 1 Chemotherapy Combination Cohort only: additionally, participants with active bleeding diathesis
* Participant has had prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives whichever is longer, before the first administration of study drug. For agents with long half-lives, the maximum required time since last dose is 4 weeks. Toxicities from previous anti-cancer therapies should have resolved to baseline levels or to Grade 1 or less, (except for alopecia [any grade], Grade less than or equal to [<=] 2 peripheral neuropathy, and Grade less than [<] 2 hypothyroidism stable on hormone replacement). For Part 1 Combination Dose Escalation: Any previous treatment with systemic anti-cancer immunotherapy, including but not limited to anti-PD-1, anti-PD-L1, and anti-CTLA-4 agents. For Part 1 Chemotherapy Combination Cohort only: Any previous treatment with systemic anti-cancer immunotherapy in the past 3 months or localized radiotherapy to lung within the past 6 months. For Part 2 only: Cohorts A and B: Prior treatment with chemotherapy for metastatic disease is not allowed unless the tumor mutation carries de-novo resistance to EGFR TKI (example, Exon 20 insertions). Cohort C and MET-1: Prior treatment with more than 2 lines of cytotoxic chemotherapy for metastatic disease (maintenance therapy is not included). Cohort D: Previous treatment with an EGFR TKI with activity against EGFR Exon 20 insertions (such as poziotinib). Cohort E (combination Amivantamab and lazertinib): Any previous treatment in the metastatic setting with other than a first, second, or third generation EGFR TKI. Cohorts WT-Ad and WT-Sq: more than three lines of prior systemic therapy in the metastatic setting
* Participants with untreated brain metastases. Participants with definitively, locally-treated metastases that are clinically stable and asymptomatic for at least 2 weeks and who are off or receiving low-dose corticosteroid treatment (<=10 mg prednisone or equivalent) for at least 2 weeks prior to study treatment are eligible. Exception: participants with asymptomatic, untreated brain metastases, each less than 1 cm in diameter, may be eligible for Amivantamab and lazertinib combination therapy in the Part 1 Combination Dose Escalation or Part 2 Combination Expansion Cohort E
* Participant has a history of malignancy other than the disease under study within 3 years before Screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with or minimal risk of recurrence within a year from Screening)
* Participant has not fully recovered from major surgery or significant traumatic injury prior the first dose of study drug or expects to have major surgery during the study period or within 6 months after the last dose of study drug
* Participant has, or will have, any of the following: a. An invasive operative procedure with entry into a body cavity, within 4 weeks or without complete recovery before Cycle 1 Day 1. Thoracentesis, if needed, and percutaneous biopsy for baseline tumor tissue sample may be done less than 4 weeks prior to Cycle 1 Day 1, as long as the participant has adequately recovered from the procedure prior to the first dose of study drug in the clinical judgement of the investigator; b. Significant traumatic injury within 3 weeks before the start of Cycle 1 Day 1 (all wounds must be fully healed prior to Day 1); c. Any medical condition that requires intact wound healing capacity and is expected to endanger subject safety if wound healing capacity would be severely reduced during administration of the investigational agent; d. Expected major surgery while the investigational agent is being administered or within 6 months after the last dose of study drug

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 1
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
24/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
Accrual to date
Final
751
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Heidelberg
Recruitment hospital [3] 0 0
- Kogarah
Recruitment hospital [4] 0 0
- Murdoch
Recruitment hospital [5] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Heidelberg
Recruitment postcode(s) [3] 0 0
- Kogarah
Recruitment postcode(s) [4] 0 0
- Murdoch
Recruitment postcode(s) [5] 0 0
- 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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
China
State/province [15] 0 0
Beijing
Country [16] 0 0
China
State/province [16] 0 0
Changchun
Country [17] 0 0
China
State/province [17] 0 0
Changsha
Country [18] 0 0
China
State/province [18] 0 0
Chengdu
Country [19] 0 0
China
State/province [19] 0 0
Chongqing
Country [20] 0 0
China
State/province [20] 0 0
Guangzhou
Country [21] 0 0
China
State/province [21] 0 0
Hangzhou
Country [22] 0 0
China
State/province [22] 0 0
Hefei
Country [23] 0 0
China
State/province [23] 0 0
Nanchang
Country [24] 0 0
China
State/province [24] 0 0
Nanjing
Country [25] 0 0
China
State/province [25] 0 0
Wuhan
Country [26] 0 0
China
State/province [26] 0 0
Zhengzhou
Country [27] 0 0
France
State/province [27] 0 0
Bordeaux
Country [28] 0 0
France
State/province [28] 0 0
Dijon
Country [29] 0 0
France
State/province [29] 0 0
Lyon Cedex 8
Country [30] 0 0
France
State/province [30] 0 0
Marseille
Country [31] 0 0
France
State/province [31] 0 0
Paris
Country [32] 0 0
France
State/province [32] 0 0
Saint-Herblain Cedex
Country [33] 0 0
France
State/province [33] 0 0
Villejuif Cedex
Country [34] 0 0
Japan
State/province [34] 0 0
Chuo Ku
Country [35] 0 0
Japan
State/province [35] 0 0
Hyogo
Country [36] 0 0
Japan
State/province [36] 0 0
Kashiwa
Country [37] 0 0
Japan
State/province [37] 0 0
Kurume
Country [38] 0 0
Japan
State/province [38] 0 0
Nagoya Shi
Country [39] 0 0
Japan
State/province [39] 0 0
Niigata
Country [40] 0 0
Japan
State/province [40] 0 0
Osaka
Country [41] 0 0
Japan
State/province [41] 0 0
Tokyo
Country [42] 0 0
Japan
State/province [42] 0 0
Wakayama
Country [43] 0 0
Japan
State/province [43] 0 0
Yonago
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Cheongju-si
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Goyang si
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Incheon
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Seongnam-si
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Seoul
Country [49] 0 0
Spain
State/province [49] 0 0
A Coruna
Country [50] 0 0
Spain
State/province [50] 0 0
Barcelona
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Santander
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Spain
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Seville
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
Country [57] 0 0
Taiwan
State/province [57] 0 0
Taipei City
Country [58] 0 0
Taiwan
State/province [58] 0 0
Taipei
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Manchester
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Newcastle upon Tyne
Country [61] 0 0
United Kingdom
State/province [61] 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

No information has been provided regarding IPD availability


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/NCT02609776