Clinical Trials in Italy / NCT05488314
Active, not recruiting
Phase 1/2
A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer
NCT05488314 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Carcinoma, Non-Small-Cell Lung
Investigational drug(s) / intervention(s)
Capmatinib: Capmatinib will be administered orally.
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\[s\]) of the amivantamab and capmatinib 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 amivantamab and capmatinib combination therapy in mesenchymal-epithelial transition (MET) exon 14 skipping mutation and MET amplified NSCLC, when administered at the selected RP2CD(s) in Phase 2 (expansion).
Eligibility
Inclusion Criteria:
* Previously diagnosed with histologically or cytologically confirmed unresectable Stage IV (metastatic) non-small cell lung cancer (NSCLC) (any histology)
* May have: definitively, locally treated brain metastases that are clinically stable and asymptomatic for greater than (\>) 2 weeks and who are off or receiving low-dose corticosteroid treatment (less than or equal to \[\<=\]10 milligrams (mg) prednisone or equivalent) for at least 2 weeks prior to start of study treatment
* May have a prior malignancy (other than the disease under study) the natural history or treatment of which is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* A participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
Exclusion Criteria:
* 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
* Participant has impairment of the gastrointestinal function that could affect absorption of capmatinib or is unable or unwilling to swallow tablets
* Participant has symptomatic central nervous system (CNS) metastases which are neurologically unstable or have required increasing doses of steroids \>10 mg prednisone or equivalent within the 2 weeks prior to study entry to manage CNS symptoms
* Participant has uncontrolled tumor-related pain: Symptomatic lesions amenable to palliative radiotherapy (example, bone metastases, or metastases causing nerve impingement) should be treated more than 7 days prior to the administration of the first study treatment
Primary outcome measure(s)
- Phase 1: Number of Participants with Adverse events (AEs) by Severity — Up to 2 years 1 month
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) — 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, hematologic toxicity, pulmonary toxicity, liver enzyme elevation, or treatment delay greater than (\>) 28 days due to unresolved toxicity. - Phase 2: Objective Response Rate — Up to 2 years 1 month
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.
Trial sites (78)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham, Comprehensive Cancer Center | Birmingham | Alabama | |
| The Oncology Institute of Hope and Innovation | Cerritos | California | |
| UCLA | Los Angeles | California | |
| Montefiore Einstein Center for Cancer Care | The Bronx | New York | |
| Virginia Cancer Specialists | Fairfax | Virginia | |
| PERSONAL Oncologia de Precisao e Personalizada | Belo Horizonte | Brazil | |
| CIONC Centro Integrado de Oncologia de Curitiba | Curitiba | Brazil | |
| UPCO Unidade de Pesquisa Clinica em Oncologia | Pelotas | Brazil | |
| Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS | Porto Alegre | Brazil | |
| Oncoclinicas Rio de Janeiro S A | Rio de Janeiro | Brazil | |
| Instituto D Or de Pesquisa e Ensino IDOR | Rio de Janeiro | Brazil | |
| Nucleo de Oncologia da Bahia | Salvador | Brazil | |
| Sociedade Beneficente de Senhoras Hospital Sirio Libanes | São Paulo | Brazil | |
| Fundacao Antonio Prudente A C Camargo Cancer Center | São Paulo | Brazil | |
| The Ottawa Hospital Research Institute | Ottawa | Ontario | |
| Princess Margaret Cancer Centre University Health Network | Toronto | Ontario | |
| Beijing Cancer Hospital | Beijing | China | |
| Sichuan Cancer Hospital | Chengdu | China | |
| West China Hospital Sichuan University | Chengdu | China | |
| Chongqing University Cancer Hospital | Chongqing | China | |
| The First Affiliated Hospital Sun Yat sen University | Guangzhou | China | |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | China | |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | China | |
| Huizhou Municipal Central Hospital | Huizhou | China | |
| Fudan University Shanghai Cancer Center | Shanghai | China | |
| Shanghai Pulmonary Hospital | Shanghai | China | |
| Shengjing Hospital Of China Medical University | Shenyang | China | |
| The First Affiliated Hospital of Xian Jiaotong University | Xi'an | China | |
| Yantai Yuhuangding Hospital | Yantai | China | |
| Henan Cancer Hospital | Zhengzhou | China | |
| Institute Coeur Poumon | Lille | France | |
| CHU de la Timone | Marseille | France | |
| Institut de cancerologie de l'ouest | Saint-Herblain | France | |
| Nouvel Hopital Civil - CHU Strasbourg | Strasbourg | France | |
| Charite Universitaetsmedizin Berlin | Berlin | Germany | |
| Klinikum Chemnitz gGmbH | Chemnitz | Germany | |
| Universitaetsklinikum Koeln | Cologne | Germany | |
| Universitaetsklinikum Carl Gustav Carus TU Dresden | Dresden | Germany | |
| Universitaetsklinikum Essen | Essen | Germany | |
| Universitaetsklinikum Muenster | Münster | Germany |
+ 38 more sites — see the full list on the official registry below.
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Official registry record
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 NCT05488314 on ClinicalTrials.gov ↗ ← All trials in Italy