Trial Title:
A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer
NCT ID:
NCT05908734
Condition:
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Amivantamab-vmjw
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cetrelimab
Description:
Cetrelimab will be administered as IV infusion.
Arm group label:
Phase 1 (Combination Dose Selection)
Arm group label:
Phase 2 (Dose Expansion)
Other name:
JNJ-63723283
Intervention type:
Drug
Intervention name:
Amivantamab
Description:
Amivantamab will be administered as IV infusion.
Arm group label:
Phase 1 (Combination Dose Selection)
Arm group label:
Phase 2 (Dose Expansion)
Other name:
JNJ-61186372
Summary:
The purpose of this study is to identify the recommended Phase 2 (combination) dose
(RP2CD) of the amivantamab and cetrelimab combination therapy in participants with
non-small cell lung cancer (NSCLC) in Phase 1 (combination dose selection); and to
evaluate the antitumor effect of the combination at the selected RP2CD in participants
with NSCLC characterized on the basis of epidermal growth factor receptor (EGFR) and
Programmed-cell death Ligand (PD-L)1 status, in the Phase 2 (expansion).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participant must have histologically or cytologically confirmed non-small cell lung
cancer (NSCLC) (any histology), and must have metastatic NSCLC at the time of
enrollment: Phase 1 (Combination Dose Selection) Cohort; Metastatic NSCLC progressed
on or after standard of care systemic anti-cancer therapy and participant is
declining other systemic treatment options, if any;1. Participants without known
mutations must have had disease progression on, or have intolerance to, prior
platinum-based chemotherapy and PD-(L)1-targeted immunotherapy given concurrently or
sequentially, OR 2. Participants with NSCLC characterized by known driver mutations
must have had disease progression on, or have intolerance to, appropriate targeted
therapies as per local standard of care. Participants may have received prior
therapy with amivantamab as long as discontinuation was not due to toxicity.
Participants with EGFR mutation must not have had an anti-PD-1/PD-L1 therapy, Phase
2 Expansion Cohorts; Cohort A: Participant's tumor must have an EGFR exon19del or
L858R mutation, as determined by local molecular testing, Cohort B: Participants
must have tumors lacking known primary driver mutations and must have PD-L1
expression of greater than or equal to (>=)50 percentage (%), per local testing, and
are treatment-naïve in the metastatic setting
- Participant must have at least 1 measurable lesion, according to Response Evaluation
Criteria in Solid Tumors (RECIST) v1.1, that has not been previously irradiated
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- Participant has an uncontrolled illness, including but not limited to: a.
Uncontrolled diabetes, b. Ongoing or active infection (includes infection requiring
treatment with antimicrobial therapy [participants will be required to complete
antibiotics 1 week prior to starting study treatment] or diagnosed or suspected
viral infection), c. Active bleeding diathesis, d. Impaired oxygenation requiring
continuous oxygen supplementation, e. Psychiatric illness or any other circumstances
(including social circumstances) that would limit compliance with study requirements
- Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or
has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out
by imaging at screening
- Has an active autoimmune disease or a documented history of autoimmune disease that
requires systemic steroids or immunosuppressive agents
- Participant has received radiotherapy for palliative purposes less than 14 days
prior to the first dose of study treatment
- Participant has a. (or has a history of) leptomeningeal disease (carcinomatous
meningitis), b. spinal cord compression not definitively treated with surgery or
radiation
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
City of Hope Orange County Lennar Foundation Cancer Center
Address:
City:
Irvine
Zip:
92618
Country:
United States
Status:
Recruiting
Facility:
Name:
Cancer and Blood Specialty Clinic
Address:
City:
Los Alamitos
Zip:
90720
Country:
United States
Status:
Recruiting
Facility:
Name:
Providence Portland Medical Center
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Facility:
Name:
Providence Oncology and Hematology Care Clinic Westside
Address:
City:
Portland
Zip:
97225
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Fundacao Pio XII
Address:
City:
Barretos
Zip:
14784 400
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Cetus Oncologia
Address:
City:
Belo Horizonte
Zip:
30110 022
Country:
Brazil
Status:
Recruiting
Facility:
Name:
CIONC Centro Integrado de Oncologia de Curitiba
Address:
City:
Curitiba
Zip:
80810 050
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Nossa Senhora da Conceicao S A
Address:
City:
Porto Alegre
Zip:
91350 200
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Santa Izabel Santa Casa de Misericordia da Bahia
Address:
City:
Salvador
Zip:
40050-410
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Fundacao Antonio Prudente A C Camargo Cancer Center
Address:
City:
Sao Paulo
Zip:
01509 900
Country:
Brazil
Status:
Recruiting
Facility:
Name:
European Institute of Oncology
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Recruiting
Facility:
Name:
ASST Grande Ospedale Metropolitano Niguarda
Address:
City:
Milano
Zip:
20162
Country:
Italy
Status:
Recruiting
Facility:
Name:
Aou San Luigi Gonzaga
Address:
City:
Orbassano
Zip:
10043
Country:
Italy
Status:
Recruiting
Facility:
Name:
Centro Ricerche Cliniche di Verona S r l
Address:
City:
Verona
Zip:
37134
Country:
Italy
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
University Malaya Medical Centre
Address:
City:
Kuala Lumpur
Zip:
59100
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Hospital Umum Sarawak
Address:
City:
Kuching
Zip:
93586
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o
Address:
City:
Lublin
Zip:
20 609
Country:
Poland
Status:
Recruiting
Facility:
Name:
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow
Address:
City:
Poznan
Zip:
60 569
Country:
Poland
Status:
Recruiting
Facility:
Name:
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Address:
City:
Warszawa
Zip:
02 781
Country:
Poland
Status:
Recruiting
Facility:
Name:
Hosp. Gral. Univ. de Alicante
Address:
City:
Alicante
Zip:
03010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Univ. Quiron Dexeus
Address:
City:
Barcelona
Zip:
8028
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Univ. 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Virgen Macarena
Address:
City:
Sevilla
Zip:
41009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Instituto Valenciano de Oncologia
Address:
City:
Valencia
Zip:
46009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Address:
City:
Ankara
Zip:
06200
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Ankara Bilkent City Hospital
Address:
City:
Ankara
Zip:
06800
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Ankara Bilkent City Hospital
Address:
City:
Cankaya
Zip:
06800
Country:
Turkey
Status:
Completed
Facility:
Name:
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Address:
City:
Istanbul
Zip:
34722
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Sakarya University Training and Research Hospital
Address:
City:
Sakarya
Zip:
54100
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Imperial College London and Imperial College Healthcare NHS Trust
Address:
City:
London
Zip:
W6 8RF
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Royal Marsden Hospital
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Recruiting
Start date:
May 18, 2023
Completion date:
March 26, 2026
Lead sponsor:
Agency:
Janssen Research & Development, LLC
Agency class:
Industry
Source:
Janssen Research & Development, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05908734
