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| ID | Type | Description | Link |
|---|---|---|---|
| 61186372PANSC2001 | Other Identifier | Janssen Research & Development, LLC | |
| 2022-000485-18 | EudraCT Number | ||
| 2023-508256-19-00 | Registry Identifier | EUCT number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 (Combination Dose Selection) | Experimental | Participants will receive capmatinib 400 milligrams (mg) orally twice daily from Cycle 1 Day 1, in combination with amivantamab 700 mg intravenous (IV) infusion (for body weight less than 80 kilograms [kg]) or 1050 mg IV infusion (for body weight greater than or equal to 80 kg) once weekly from Cycle 1 Day 1 for 4 weeks and then every 2 weeks from Week 5 (Cycle 2; each cycle of 28 days). Doses will be escalated or de-escalated based on the dose limiting toxicities (DLTs) and the recommended Phase 2 combination dose (RP2CD) will be determined by the study evaluation team (SET). |
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| Phase 2 (Dose Expansion) | Experimental | Participants with mesenchymal-epithelial transition (MET) exon 14 skipping mutation who are treatment naïve (Cohort 1A), who have received prior therapy (Cohort 1B), or participants with MET amplification who have received prior therapy (Cohort 1C) will receive capmatinib in combination with amivantamab at the RP2CD determined by the SET in Phase 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capmatinib | Drug | Capmatinib will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Number of Participants with Adverse events (AEs) by Severity | 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. | Up to 2 years 1 month |
| Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs) | 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. | Cycle 1 (Day 1 through Day 28) |
| Phase 2: Objective Response Rate | 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. | Up to 2 years 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Number of Participants with AEs by Severity | 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 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham, Comprehensive Cancer Center | Birmingham | Alabama | 35233 | United States | ||
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Amivantamab | Drug | Amivantamab will be administered as IV infusion. |
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| Up to 2 years 1 month |
| Phase 1: Number of Participants with Abnormalities in Clinical Laboratory Parameters | Number of participants with abnormalities in clinical laboratory parameters (serum chemistry, hematology, coagulation, serology, and urinalysis) will be reported. | Up to 2 years 1 month |
| Phase 2: Duration of Response (DoR) | DoR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death from any case, whichever comes first, for participants who have PR or CR. | Up to 2 years 1 month |
| Phase 2: Disease Control Rate (DCR) | DCR is defined as the percentage of participants who achieve a PR, CR, or stable disease using RECIST version 1.1. | Up to 2 years 1 month |
| Phase 2: Progression Free Survival (PFS) | PFS is defined as the time from first dose date until the date of disease progression or death, whichever comes first, based on investigator assessment using RECIST version 1.1 | Up to 2 years 1 month |
| Phase 2: Overall Survival (OS) | OS is defined as the time from the date of administration of the first study treatment until the date of death due to any cause. | Up to 2 years 1 month |
| Phase 2: Time to Subsequent Therapy (TTST) | TTST is defined as the time from the date of administration of the first study treatment to the start date of the subsequent anticancer therapy following study treatment discontinuation, or death, whichever comes first. | Up to 2 years 1 month |
| Phase 2 (Cohort 1A): Change from Baseline in Health-related Quality of Life in (HRQoL) as Assessed by European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score | EORTC-QLQ-C30 is a self-administered, 30-item questionnaire developed to assess the HRQoL of cancer participants. | Baseline up to 2 years 1 month |
| Phase 2 (Cohort 1A): HRQoL as Assessed by Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NSCLC-SAQ) Scale Score | NSCLC-SAQ assesses patient-reported symptom severity associated with NSCLC. | Up to 2 years 1 month |
| Phase 2 (Cohort 1A): HRQoL as Assessed by EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scale Score | EQ-5D-5L is a self-administered, standardized measure of health status. | Up to 2 years 1 month |
| Phase 2 (Cohort 1A): HRQoL as Assessed by Patient-reported Outcomes Measurement Information System Short Form Version 2.0 - Physical Function 8c (PROMIS PF 8c) Scale Score | PROMIS PF 8c is an 8-item fixed length short form derived from the PROMIS Physical Function item bank. It assesses activities of daily living, mobility, and global impact of physical functioning. | Up to 2 years 1 month |
| The Oncology Institute of Hope and Innovation |
| Cerritos |
| California |
| 90703 |
| United States |
| UCLA | Los Angeles | California | 90095 | United States |
| Montefiore Einstein Center for Cancer Care | The Bronx | New York | 10467 | United States |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | United States |
| PERSONAL Oncologia de Precisao e Personalizada | Belo Horizonte | 30130-090 | Brazil |
| CIONC Centro Integrado de Oncologia de Curitiba | Curitiba | 80810 050 | Brazil |
| UPCO Unidade de Pesquisa Clinica em Oncologia | Pelotas | 96020 080 | Brazil |
| Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS | Porto Alegre | 90610-000 | Brazil |
| Oncoclinicas Rio de Janeiro S A | Rio de Janeiro | 22 250 905 | Brazil |
| Instituto D Or de Pesquisa e Ensino IDOR | Rio de Janeiro | 22281 100 | Brazil |
| Nucleo de Oncologia da Bahia | Salvador | 40170 110 | Brazil |
| Sociedade Beneficente de Senhoras Hospital Sirio Libanes | São Paulo | 01308 901 | Brazil |
| Fundacao Antonio Prudente A C Camargo Cancer Center | São Paulo | 01509 900 | Brazil |
| The Ottawa Hospital Research Institute | Ottawa | Ontario | K1Y 4E9 | Canada |
| Princess Margaret Cancer Centre University Health Network | Toronto | Ontario | M5G 1Z5 | Canada |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| Sichuan Cancer Hospital | Chengdu | 610041 | China |
| West China Hospital Sichuan University | Chengdu | 610041 | China |
| Chongqing University Cancer Hospital | Chongqing | 400030 | China |
| The First Affiliated Hospital Sun Yat sen University | Guangzhou | 510060 | China |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | 310009 | China |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | 310016 | China |
| Huizhou Municipal Central Hospital | Huizhou | 516001 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
| Shanghai Pulmonary Hospital | Shanghai | 200433 | China |
| Shengjing Hospital Of China Medical University | Shenyang | 110055 | China |
| The First Affiliated Hospital of Xian Jiaotong University | Xi'an | 710061 | China |
| Yantai Yuhuangding Hospital | Yantai | 264000 | China |
| Henan Cancer Hospital | Zhengzhou | 450008 | China |
| Institute Coeur Poumon | Lille | 59000 | France |
| CHU de la Timone | Marseille | 13005 | France |
| Institut de cancerologie de l'ouest | Saint-Herblain | 44805 | France |
| Nouvel Hopital Civil - CHU Strasbourg | Strasbourg | 67091 | France |
| Charite Universitaetsmedizin Berlin | Berlin | 12203 | Germany |
| Klinikum Chemnitz gGmbH | Chemnitz | 09116 | Germany |
| Universitaetsklinikum Koeln | Cologne | 50937 | Germany |
| Universitaetsklinikum Carl Gustav Carus TU Dresden | Dresden | 01307 | Germany |
| Universitaetsklinikum Essen | Essen | 45147 | Germany |
| Universitaetsklinikum Muenster | Münster | 48149 | Germany |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | 20133 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | 20162 | Italy |
| Fondazione G Pascale Istituto Nazionale Tumori IRCCS | Naples | 80131 | Italy |
| Istituto Oncologico Veneto - IRCCS | Padova | 35128 | Italy |
| Ospedale S. Maria Delle Croci | Ravenna | 48121 | Italy |
| Istituto Nazionale Tumori Regina Elena | Rome | 00128 | Italy |
| National Hospital Organization Nagoya Medical Center | Nagoya | 460-0001 | Japan |
| Shizuoka Cancer Center | Sunto Gun | 411 8777 | Japan |
| The Cancer Institute Hospital of JFCR | Tokyo | 135 8550 | Japan |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80 214 | Poland |
| INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o | Lublin | 20 609 | Poland |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy | Warsaw | 02 781 | Poland |
| Chungbuk National University Hospital | Cheongju-si | 28644 | South Korea |
| National Cancer Center | Goyang-si | 10408 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Chonnam National University Hwasun Hospital | Jeollanam-do | 58128 | South Korea |
| Seoul National University Bundang Hospital | Seongnam | 13620 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Hosp Univ A Coruna | A Coruña | 15006 | Spain |
| Hosp. Gral. Univ. de Alicante | Alicante | 03010 | Spain |
| Hosp. Del Mar | Barcelona | 08003 | Spain |
| Hosp. Univ. Quiron Dexeus | Barcelona | 08028 | Spain |
| Hosp Univ Vall D Hebron | Barcelona | 08035 | Spain |
| Hosp Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hosp Univ Fund Jimenez Diaz | Madrid | 28040 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Hosp. Univ. La Paz | Madrid | 28046 | Spain |
| Hosp. Virgen Macarena | Seville | 41009 | Spain |
| Hosp. Clinico Univ. de Valencia | Valencia | 46010 | Spain |
| Gazi University Hospital | Ankara | 06560 | Turkey (Türkiye) |
| Ankara Bilkent City Hospital | Ankara | 06800 | Turkey (Türkiye) |
| Ankara Bilkent Sehir Hastanesi | Çankaya | 06800 | Turkey (Türkiye) |
| University College London Hospitals Nhs Foundation Trust | London | NW1 2PG | United Kingdom |
| Imperial College London and Imperial College Healthcare NHS Trust | London | W2 1NY | United Kingdom |
| Sir Bobby Robson Cancer Trials Research Centre | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Royal Marsden Hospital | Sutton | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000613976 | capmatinib |
| C000718215 | amivantamab |
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