Clinical trial NCT05908734: A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer
Official title: A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Cetrelimab Combination Therapy in Metastatic Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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).


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

Primary outcomes:
measure: Phase 1: Number of Participants with Adverse events (AEs) by Severity
timeFrame: Up to 2 years 3 months
measure: Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs)
timeFrame: Up to Cycle 1 (Day 1 through Day 28)
measure: Phase 2: Objective Response Rate
timeFrame: Up to 2 years 3 months
Secondary outcomes:
measure: Phase 1 and Phase 2: Number of Participants with AEs by Severity
timeFrame: Up to 2 years 3 months
measure: Phase 1 and Phase 2: Number of Participants with Abnormalities in Clinical Laboratory Parameters
timeFrame: Up to 2 years 3 months
measure: Phase 2 : Duration of Response (DoR)
timeFrame: Up to 2 years 3 months
measure: Phase 2: Disease Control Rate (DCR)
timeFrame: Up to 2 years 3 months
measure: Phase 2: Progression Free Survival (PFS)
timeFrame: Up to 2 years 3 months
measure: Phase 2: Overall Survival (OS)
timeFrame: Up to 2 years 3 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Irvine
country: United States
facility: City of Hope Orange County Lennar Foundation Cancer Center
state: California
city: Los Alamitos
country: United States
facility: Cancer and Blood Specialty Clinic
state: California
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence Oncology and Hematology Care Clinic Westside
state: Oregon
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Barretos
country: Brazil
facility: Fundacao Pio XII
city: Belo Horizonte
country: Brazil
facility: Cetus Oncologia
city: Belo Horizonte
country: Brazil
facility: PERSONAL Oncologia de Precisao e Personalizada
city: Curitiba
country: Brazil
facility: CIONC Centro Integrado de Oncologia de Curitiba
city: Londrina
country: Brazil
facility: Hospital do Cancer de Londrina
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao S A
city: Salvador
country: Brazil
facility: Hospital Santa Izabel Santa Casa de Misericordia da Bahia
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente A C Camargo Cancer Center
city: Milano
country: Italy
facility: European Institute of Oncology
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Orbassano
country: Italy
facility: Aou San Luigi Gonzaga
city: Verona
country: Italy
facility: Centro Ricerche Cliniche di Verona S r l
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
city: Lublin
country: Poland
facility: INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
city: Alicante
country: Spain
facility: Hosp. Gral. Univ. de Alicante
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Barcelona
country: Spain
facility: Hosp. Univ. Quiron Dexeus
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Sevilla
country: Spain
facility: Hosp. Virgen Macarena
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia
city: Adana
country: Turkey
facility: Adana City Hospital
city: Ankara
country: Turkey
facility: Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Cankaya
country: Turkey
facility: Ankara Bilkent City Hospital
city: Istanbul
country: Turkey
facility: Bakirkoy Sadi Konuk Training and Research Hospital
city: Istanbul
country: Turkey
facility: Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
city: Izmir
country: Turkey
facility: Medicana International Izmir
city: Sakarya
country: Turkey
facility: Sakarya University Training and Research Hospital
city: London
country: United Kingdom
facility: Imperial College London and Imperial College Healthcare NHS Trust
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical trial
role: STUDY_DIRECTOR
References: