A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Cetrelimab: Cetrelimab will be administered as IV infusion.
Amivantamab: Amivantamab will be administered as IV infusion.
Study 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
Primary outcome measure(s)
- Phase 1: Number of Participants with Adverse events (AEs) by Severity — Up to 2 years 3 months
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. - Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs) — Up to Cycle 1 (Day 1 through Day 28)
The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, hematological toxicity, pulmonary toxicity, liver enzyme elevation, treatment delay greater than (\>) 28 days due to unresolved toxicity, or immune-related toxicity requiring the use of therapies in excess of corticosteroids. - Phase 2: Objective Response Rate — Up to 2 years 3 months
ORR is defined as the percentage of participants who achieve either a confirmed partial response (PR) or complete response (CR), using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as per investigator assessment.
Trial sites (44)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope | Duarte | California | |
| City of Hope Orange County Lennar Foundation Cancer Center | Irvine | California | |
| Cancer and Blood Specialty Clinic | Los Alamitos | California | |
| Providence Portland Medical Center | Portland | Oregon | |
| Providence Oncology and Hematology Care Clinic Westside | Portland | Oregon | |
| MD Anderson Cancer Center | Houston | Texas | |
| Virginia Cancer Specialists | Fairfax | Virginia | |
| Fundacao Pio XII | Barretos | Brazil | |
| Cetus Oncologia | Belo Horizonte | Brazil | |
| PERSONAL Oncologia de Precisao e Personalizada | Belo Horizonte | Brazil | |
| CIONC Centro Integrado de Oncologia de Curitiba | Curitiba | Brazil | |
| Hospital do Cancer de Londrina | Londrina | Brazil | |
| Hospital Nossa Senhora da Conceicao S A | Porto Alegre | Brazil | |
| Hospital Santa Izabel Santa Casa de Misericordia da Bahia | Salvador | Brazil | |
| Fundacao Antonio Prudente A C Camargo Cancer Center | São Paulo | Brazil | |
| European Institute of Oncology | Milan | Italy | |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Italy | |
| Aou San Luigi Gonzaga | Orbassano | Italy | |
| Centro Ricerche Cliniche di Verona S r l | Verona | Italy | |
| University Malaya Medical Centre | Kuala Lumpur | Malaysia | |
| Hospital Umum Sarawak | Kuching | Malaysia | |
| INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o | Lublin | Poland | |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow | Poznan | Poland | |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy | Warsaw | Poland | |
| Seoul National University Hospital | Seoul | South Korea | |
| Severance Hospital Yonsei University Health System | Seoul | South Korea | |
| Samsung Medical Center | Seoul | South Korea | |
| Hosp. Gral. Univ. de Alicante | Alicante | Spain | |
| Hosp Univ Vall D Hebron | Barcelona | Spain | |
| Hosp. Univ. Quiron Dexeus | Barcelona | Spain | |
| Hosp. Univ. 12 de Octubre | Madrid | Spain | |
| Hosp. Virgen Macarena | Seville | Spain | |
| Instituto Valenciano de Oncologia | Valencia | Spain | |
| Adana City Hospital | Adana | Turkey (Türkiye) | |
| Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi | Ankara | Turkey (Türkiye) | |
| Ankara Bilkent Sehir Hastanesi 1 | Ankara | Turkey (Türkiye) | |
| Ankara Bilkent Sehir Hastanesi | Ankara | Turkey (Türkiye) | |
| Bakirkoy Sadi Konuk Training and Research Hospital | Istanbul | Turkey (Türkiye) | |
| Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi | Istanbul | Turkey (Türkiye) | |
| Medicana International Izmir | Izmir | Turkey (Türkiye) |
+ 4 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05908734 on ClinicalTrials.gov ↗ ← All trials in South Korea