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| ID | Type | Description | Link |
|---|---|---|---|
| 61186372NSC3001 | Other Identifier | Janssen Research & Development, LLC | |
| 2020-000633-40 | EudraCT Number | ||
| 2023-506033-29-00 | Registry Identifier | EUCT number |
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The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Amivantamab + Chemotherapy | Experimental | Participants will receive pemetrexed 500 milligram per meter square (mg/m^2) intravenous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin for up to 4 cycles, and then as maintenance monotherapy until disease progression. Carboplatin area under the concentration-time curve 5 milligram per milliliter (mg/mL) per minute (AUC 5) will be administered as IV infusion on Day 1 of each 21 day cycle, for up to 4 cycles. Participants will receive amivantamab 1400 mg (1750 mg if body weight is >=80 kilogram [kg]) by IV infusion once weekly up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is >=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3. Following the primary analysis for efficacy, the study will transition to an OLE phase and participants will continue to receive the amivantamab plus chemotherapy in OLE phase. Participants who completed OLE period will enter LTE period and continue to receive same treatment. |
|
| Arm B: Chemotherapy Alone | Experimental | Participants will receive pemetrexed 500 mg/m^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin for up to 4 cycles, and then as maintenance monotherapy until disease progression. Carboplatin AUC 5 IV infusion will be administered on Day 1 of each 21-day cycle for up to 4 cycles. Following the primary analysis for efficacy, the study will transition to an OLE phase and participants will either continue to receive the chemotherapy or cross over to amivantamab in OLE phase. Participants who completed OLE period will enter LTE period and continue to receive same treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amivantamab | Drug | Amivantamab will be administered as an IV infusion at a dose of 1400 mg (1750 mg if body weight is >=80 kilogram [kg]) by once weekly up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is >=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3 and will continue the same treatment in OLE phase then in LTE phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR) | PFS was defined as the time from randomization until the date of objective disease progression based on BICR using RECIST version 1.1 or death (by any cause) in the absence of progression, whichever came first. Participants who have not progressed or have not died at the time of analysis were censored at the time of the latest date of their last evaluable RECIST version 1.1 assessment. Pharmacodynamic: Sum of diameters increased by greater than or equal to (>=)20 percent (%) and >=5 millimeter (mm) from nadir (including baseline if it was smallest sum). | From randomization to either disease progression or death whichever occurs first (up to 29 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Up to 5 years 3 months | |
| Duration of Response (DoR) | Up to 5 years 3 months | |
| Overall Survival (OS) |
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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 |
|---|---|---|---|---|---|---|
| City of Hope 2 | Duarte | California | 91010 | United States | ||
| University of California Irvine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42192224 | Derived | Tang K, Wu F, Yang F, Yao Y, Zhao Y, Zhou J, Sun P, Wang D, Lv D, Wang H, Hu Y, Li Q, Song Y, Gao G, Pan F, Bhattacharya A, Baig M, Lorenzini PA, Wortman-Vayn H, Agrawal T, Zhou C. Amivantamab plus chemotherapy vs. chemotherapy as first-line treatment in Chinese mainland patients with EGFR exon 20 insertion non-small cell lung cancer: Subgroup analysis of the randomized PAPILLON trial. Chin Med J (Engl). 2026 May 26. doi: 10.1097/CM9.0000000000004134. Online ahead of print. | |
| 41671628 |
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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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Currently, the results are posted till cut-off date 03-May-2023. After completion of open-label extension (OLE) phase participant were allowed to enter the long-term extension (LTE) phase. LTE phase is still ongoing and results will be posted upon study completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm B: Chemotherapy Alone | Participants received chemotherapy with pemetrexed 500 milligrams per meter square (mg/m^2) Intraveous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 (AUC 5) IV infusion administered on Day 1 for up to 4 cycles, and then as maintenance monotherapy until disease progression. Following the primary analysis, the study was transitioned to an open-label extension (OLE) phase, and participants either continued to receive the chemotherapy or crossover to amivantamab in the OLE phase. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 7, 2023 | May 1, 2024 |
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|
|
| Pemetrexed | Drug | Pemetrexed will be administered as 500 mg/m^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression in Arm A and will continue the same treatment in OLE phase then in LTE phase. |
|
| Carboplatin | Drug | Carboplatin will be administered as AUC 5 IV infusion for up to 4 cycles on Day 1 of each 21-day cycle. |
|
| Pemetrexed | Drug | Pemetrexed will be administered as 500 mg/m^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression in Arm B and will continue the same treatment in OLE phase then in LTE phase. |
|
| Up to 5 years 3 months |
| Time to Subsequent Therapy (TST) | Up to 5 years 3 months |
| Progression-Free Survival After First Subsequent Therapy (PFS2) | Up to 5 years 3 months |
| Time to Symptomatic Progression (TTSP) | Up to 5 years 3 months |
| Number of Participants Treatment-emergent Adverse Events (TEAEs) | From Day 1 to 5 years 2 months |
| Number of Participants TEAEs With Severity | From Day 1 to 5 years 2 months |
| Number of Participants With Clinical Laboratory Abnormalities | Up to 5 years 3 months |
| Number of Participants With Vital Signs Abnormalities | Up to 5 years 3 months |
| Number of Participants With Physical Examination Abnormalities | Up to 5 years 3 months |
| Serum Concentration of Amivantamab | Day 1 (Cycles 1, 2, 3, 5, 7, 9, 11, 13), Day 2 (Cycle 1) |
| Number of Participants With Anti-Amivantamab Antibodies | Day 1 (Cycles 1, 2, 3, 5, 7, 9, 11, 13), Day 2 (Cycle 1) |
| Change From Baseline in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) | From baseline to 5 years 3 months |
| Change From Baseline in Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) | From baseline to 5 years 3 months |
| Orange |
| California |
| 92868 |
| United States |
| UCLA | Santa Monica | California | 90404 | United States |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| H. Lee Moffitt Cancer & Research Institute | Tampa | Florida | 33612 | United States |
| University Cancer And Blood Center LLC | Athens | Georgia | 30607 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Washington University Medical Center | St Louis | Missouri | 63110 | United States |
| Regional Cancer Care Associates LLC | East Brunswick | New Jersey | 08816 | United States |
| Langone Health at NYC University, NYU School of Medicine | New York | New York | 10016 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Sanford Health | Sioux Falls | South Dakota | 57104 | United States |
| Texas Oncology Pa | Tyler | Texas | 75702 | United States |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | United States |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | United States |
| Blue Ridge Cancer Care | Salem | Virginia | 24153 | United States |
| Chris O'Brien Lifehouse | Camperdown | 2050 | Australia |
| St George Hospital | Kogarah | 2217 | Australia |
| Cabrini Medical Centre | Malvern | 3144 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | 6009 | Australia |
| UZ Leuven | Leuven | 3000 | Belgium |
| Algemeen Ziekenhuis Delta | Roeselare | 8800 | Belgium |
| CHU UCL Namur - Site Godinne | Yvoir | 5530 | Belgium |
| Fundacao Pio XII | Barretos | 14784-400 | Brazil |
| Cetus Oncologia | Belo Horizonte | 30110-017 | Brazil |
| Ynova Pesquisa Clinica | Florianópolis | 88020-210 | Brazil |
| Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda | Ijuí | 98700-000 | Brazil |
| Liga Norte Riograndense Contra O Cancer | Natal | 59062 000 | Brazil |
| UPCO Unidade de Pesquisa Clinica em Oncologia | Pelotas | 96020 080 | Brazil |
| Irmandade Santa Casa de Misericordia de Porto Alegre | Porto Alegre | 90020-090 | Brazil |
| Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS | Porto Alegre | 90610-000 | Brazil |
| Ministerio da Saude Instituto Nacional do Cancer | Rio de Janeiro | 20231 050 | 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 |
| Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo | São Paulo | 01246 000 | Brazil |
| Fundacao Antonio Prudente A C Camargo Cancer Center | São Paulo | 01509 900 | Brazil |
| Núcleo de Pesquisa São Camilo | São Paulo | 04014-002 | Brazil |
| IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado | Sorocaba | 18030-075 | Brazil |
| Hospital Evangélico de Cachoeiro de Itapemirim | Vitória | 29308-014 | Brazil |
| The Ottawa Hospital Cancer Centre | Ottawa | Ontario | K1H 8L6 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
| Beijing Cancer Hospital Chest Tumor Internal Medicine dept. II | Beijing | 100142 | China |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| Chinese PLA General Hospital | Beijing | 100853 | China |
| Beijing Chest hospital, Capital medical university | Beijing | 101199 | China |
| Peking University International Hospital | Beijing | 102206 | China |
| Jilin cancer hospital | Changchun | 130000 | China |
| Hunan Cancer Hospital Chest Tumor Internal Medicine dept. II | Changsha | 410013 | China |
| Hunan Cancer hospital | Changsha | 410013 | China |
| The First People's Hospital Of Changzhou | Changzhou | 213003 | China |
| West China Hospital Sichuan University | Chengdu | 610041 | China |
| Chongqing University Cancer Hospital | Chongqing | 400030 | China |
| Fujian Medical University Union Hospital | Fuzhou | 350001 | China |
| The First Affiliated Hospital Sun Yat sen University | Guangzhou | 510080 | China |
| The First Affiliated Hospital Zhejiang University College of Medicine | Hangzhou | 310003 | China |
| The Second Affiliated Hospital of Zhejiang University College of Medicine 1 | Hangzhou | 310009 | China |
| The Second Affiliated Hospital of Zhejiang University College of Medicine | Hangzhou | 310009 | China |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | 310016 | China |
| Zhejiang Cancer Hospital | Hangzhou | 310022 | China |
| Harbin medical university cancer hospital | Harbin | 150000 | China |
| Taizhou Hospital of Zhejiang Province | Linhai | 317000 | China |
| Nanjing Drum Tower Hospital | Nanjing | 210031 | China |
| Shanghai Chest Hospital | Shanghai | 200030 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
| Shanghai East Hospital | Shanghai | 200123 | China |
| Shanghai Pulmonary Hospital | Shanghai | 200433 | China |
| Shengjing Hospital Of China Medical University | Shenyang | 110004 | China |
| Cancer hospital Chinese Academy of Medical Sciences, Shenzhen Center | Shenzhen | 518116 | China |
| Tianjin Medical University General Hospital | Tianjin | 300052 | China |
| Weifang People's Hospital | Weifang | 261000 | China |
| TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology | Wuhan | 430030 | China |
| Hospital of Jiangnan University | Wuxi | 214122 | 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 |
| Institut Bergonie | Bordeaux | 33000 | France |
| Hospices Civils de Lyon HCL | Bron | 69500 | France |
| Centre Georges Francois Leclerc | Dijon | 21000 | France |
| Centre Hospitalier Le Mans | Le Mans | 72037 | France |
| CHR Hôpital Calmette | Lille | 59037 | France |
| CHU Nantes - Hopital Nord Laënnec | Nantes | 44093 | France |
| Institut Curie | Paris | 75005 | France |
| CHU Bordeaux | Pessac | 33604 | France |
| HIA Begin | Saint-Mandé | 94163 | France |
| Zentralklinik Bad Berka GmbH | Bad Berka | 99437 | Germany |
| Evangelische Lungenklinik Berlin | Berlin | 13125 | Germany |
| Universitaetsklinikum Koeln | Cologne | 50937 | Germany |
| Kliniken der Stadt Koeln gGmbH | Cologne | 51109 | Germany |
| Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting | Gauting | 82131 | Germany |
| Thoraxklinik am Universitatsklinikum Heidelberg | Heidelberg | 69126 | Germany |
| Onkologische Schwerpunktpraxis | Heilbronn | 74072 | Germany |
| Bethanien Krankenhaus | Moers | 47441 | Germany |
| Pius-Hospital Oldenburg | Oldenburg | 26121 | Germany |
| Oncologianova GmbH | Recklinghausen | 45659 | Germany |
| Orszagos Koranyi Tbc es Pulmonologiai Intezet | Budapest | H-1529 | Hungary |
| Mátrai Gyógyintézet-Bronchológia | Gyöngyös | 3233 | Hungary |
| Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz | Székesfehérvár | 8000 | Hungary |
| Markusovszky Egyetemi Oktatokorhaz | Szombathely | 9700 | Hungary |
| Tudogyogyintezet Torokbalint | Törökbálint | 2045 | Hungary |
| Basavatarakam Indo-American Hospital | Hyderabad | 500034 | India |
| Tata Medical Center | Kolkata | 700160 | India |
| Tata Memorial Hospital | Mumbai | 400012 | India |
| HCG Manavta Cancer Centre | Nashik | 422002 | India |
| Rajiv Gandhi Cancer Institute & Research Centre | New Delhi | 110085 | India |
| Noble Hospital Pvt Ltd | Pune | 411013 | India |
| Shaare Zedek Medical Center | Jerusalem | 91031 | Israel |
| Hadassah Medical Center | Jerusalem | 9112001 | Israel |
| Meir Medical Center | Kfar Saba | 44281 | Israel |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| A O U Sant Orsola Malpighi | Bologna | 40138 | Italy |
| Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico | Catania | 95123 | Italy |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Meldola | 47014 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| IRCCS Ospedale San Raffaele | Milan | 20132 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | 20133 | Italy |
| San Gerardo Hospital | Monza | 20052 | Italy |
| Ospedale S. Maria Delle Croci | Ravenna | 48121 | Italy |
| Irccs Gemelli | Roma | 00168 | Italy |
| Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| Juntendo University Hospital | Bunkyō City | 113 8431 | Japan |
| Saitama Medical University International Medical Center | Hidaka | 350-1298 | Japan |
| National Hospital Organization Himeji Medical Center | Himeji | 670-8520 | Japan |
| Kansai Medical University Hospital | Hirakata | 573 1191 | Japan |
| Kanazawa University Hospital | Kanazawa | 920 8641 | Japan |
| National Cancer Center Hospital East | Kashiwa | 277 8577 | Japan |
| Kishiwada City Hospital | Kishiwada | 596-8501 | Japan |
| Kobe City Medical Center General Hospital | Kobe | 650-0047 | Japan |
| Kurashiki Central Hospital | Kurashiki | 710-8602 | Japan |
| Kurume University Hospital | Kurume | 830-0011 | Japan |
| Matsusaka Municipal Hospital | Matsusaka | 515-8544 | Japan |
| National Hospital Organization Nagoya Medical Center | Nagoya | 460-0001 | Japan |
| Aichi Cancer Center Hospital | Nagoya | 464 8681 | Japan |
| Niigata Cancer Center Hospital | Niigata | 951-8566 | Japan |
| Kindai University Hospital | Osaka Sayama Shi | 589 8511 | Japan |
| Kitasato University Hospital | Sagamihara | 252-0375 | Japan |
| Hokkaido University Hospital | Sapporo | 060-8648 | Japan |
| Iwate Medical University Hospital | Shiwa-gun | 028-3695 | Japan |
| Shizuoka Cancer Center | Shizuoka | 411 8777 | Japan |
| The Cancer Institute Hospital of JFCR | Tokyo | 135 8550 | Japan |
| Ehime University Hospital | Toon-shi | 791-0295 | Japan |
| Wakayama Medical University Hospital | Wakayama | 641 8510 | Japan |
| National Hospital Organization Yamaguchi Ube Medical Center | Yamaguchi | 755-0241 | Japan |
| Hospital Pulau Pinang | George Town | 10990 | Malaysia |
| Hospital Sultan Ismail | Johor Bahru | 81100 | Malaysia |
| Hospital Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| University Malaya Medical Centre | Kuala Lumpur | 59100 | Malaysia |
| Centro Oncologico de Chihuahua | Chihuahua City | 31217 | Mexico |
| Hospital Civil de Guadalajara Fray Antonio Alcalde | Guadalajara | 44280 | Mexico |
| Mexico Centre for Clinical Research, S.A. de C.V. | Mexico City | 03100 | Mexico |
| Médica Sur | Mexico City | 14050 | Mexico |
| Instituto Nacional de Cancerologia | Mexico City | 14080 | Mexico |
| Health Pharma Professional Research | México | 03100 | Mexico |
| i Can Oncology Center | Monterrey | 64710 | Mexico |
| Oncologia Integral Satelite | Naucalpan | 53100 | Mexico |
| Centrum Onkologii im Prof F Lukaszczyka | Bydgoszcz | 85 796 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80 214 | Poland |
| Szpitale Pomorskie Sp z o o | Gdynia | 81 519 | Poland |
| Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie | Olsztyn | 10-357 | Poland |
| Private Specialist Hospitals - MedPolonia | Poznan | 60-693 | Poland |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy | Warsaw | 02-781 | Poland |
| Hosp. Cuf Descobertas | Lisbon | 1998-018 | Portugal |
| Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos | Lisbon | G1R 2J6 | Portugal |
| Centro Hospitalar Universitario do Porto, EPE | Porto | 4099-001 | Portugal |
| Instituto Portugues de Oncologia | Porto | 4200-072 | Portugal |
| Centro Hospitalar de Vila Nova de Gaia Espinho E P E | Vila Nova de Gaia | 4434 502 | Portugal |
| Pan American Center for Oncology Trials LLC | Rio Piedras | 00935 | Puerto Rico |
| Irkutsk Regional Oncology Dispensary | Irkutsk | 664035 | Russia |
| Moscow City Oncology Hospital № 62 | Krasnogorsk | 143423 | Russia |
| Krasnoyarsk Regional Oncology Dispensary | Krasnoyarsk | 660133 | Russia |
| Leningrad Regional Oncology Dispensary | Kuzmolovsky | 188663 | Russia |
| MCK | Moscow | 115533 | Russia |
| City Clinical Hospital #1 | Nal'chik | 360000 | Russia |
| Nizhny Novgorod Regional Oncological Dispensary | Nizhny Novgorod | 603000 | Russia |
| Leningrad Regional Clinical Hospital | Saint Petersburg | 194291 | Russia |
| Oncology Medical Clinics AV Medical group | Saint Petersburg | 196006 | Russia |
| N.N. Petrov Research Institute Of Oncology | Saint Petersburg | 197758 | Russia |
| Tomsk Cancer Research Institute | Tomsk | 634050 | Russia |
| Bashkir State Medical University | Ufa | 450083 | Russia |
| Yaroslavl Regional Clinical Oncology Hospital | Yaroslavl | 150054 | Russia |
| Inje University Haeundae Paik Hospital | Busan | 48108 | South Korea |
| National Cancer Center 1 | Gyeonggi-do | 10408 | South Korea |
| GyeongSang National University Hospital | Gyeongsangnam-do | 52727 | South Korea |
| Chonnam National University Hwasun Hospital | Jeollanam-do | 58128 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 13620 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea Seoul St Mary s Hospital | Seoul | 06591 | South Korea |
| Hosp Univ A Coruna | A Coruña | 15006 | Spain |
| Inst. Cat. D'Oncologia-Badalona | Badalona | 08916 | Spain |
| Hosp. de La Santa Creu I Sant Pau | Barcelona | 08025 | Spain |
| Hosp. Univ. Quiron Dexeus | Barcelona | 08028 | Spain |
| Hosp Univ Vall D Hebron | Barcelona | 08035 | Spain |
| Hosp. Univ. de Burgos | Burgos | 09003 | Spain |
| Hosp. Gral. Univ. Gregorio Maranon | Madrid | 28007 | Spain |
| Hosp. Univ. Ramon Y Cajal | Madrid | 28034 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Hosp. Univ. La Paz | Madrid | 28046 | Spain |
| Hosp. Univ. Pta. de Hierro Majadahonda | Majadahonda | 28222 | Spain |
| Hosp Virgen de La Victoria | Málaga | 29010 | Spain |
| Clinica Univ. de Navarra | Pamplona | 31008 | Spain |
| Hosp. Virgen Del Rocio | Seville | 41013 | Spain |
| Hosp. Clinico Univ. Lozano Blesa | Zaragoza | 50009 | Spain |
| Kaohsiung Medical University Chung Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| Chang Gung Medical Foundation | Kaohsiung City | 833 | Taiwan |
| Taipei Medical University Shuang Ho Hospital | New Taipei City | 23561 | Taiwan |
| Chung Shan Medical University Hospital | Taichung | 402 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Phramongkutklao Hospital and Medical College | Bangkok | 10400 | Thailand |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| Songklanagarind Hospital, Prince of Songkla University | Songkhla | 90110 | Thailand |
| Adana City Hospital | Adana | 01060 | Turkey (Türkiye) |
| Başkent University Medical Faculty Adana Application and Research Center | Adana | 01250 | Turkey (Türkiye) |
| Gazi University Hospital | Ankara | 6560 | Turkey (Türkiye) |
| Ankara Bilkent City Hospital | Ankara | 6800 | Turkey (Türkiye) |
| Trakya University Medical Faculty | Edirne | 22030 | Turkey (Türkiye) |
| Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd | Istanbul | 34098 | Turkey (Türkiye) |
| Medipol Mega University Hospital | Istanbul | 34214 | Turkey (Türkiye) |
| Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi | Istanbul | 34722 | Turkey (Türkiye) |
| Izmir Medical Park Hospital | Izmir | 35580 | Turkey (Türkiye) |
| Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4 | Dnipro | 49102 | Ukraine |
| Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies' | Kyiv | 02091 | Ukraine |
| National Cancer Institute | Kyiv | 03022 | Ukraine |
| Edinburgh Cancer Centre Western General | Edinburgh | EH4 2XU | United Kingdom |
| The Royal Marsden NHS Trust Chelsea | London | SW3 6JJ | United Kingdom |
| The Royal Marsden NHS Trust Sutton | Sutton | SM2 5PT | United Kingdom |
| Derived |
| Zhou C, Tang KJ, Liu B, Kim SW, Kitazono S, Ono A, Thiagarajan M, Hung JY, Boyer M, CIl T, Yao Y, Nagarkar R, Xie J, Bhattacharya A, Wortman-Vayn H, Baig M, Agrawal T, Lorenzini P, Lee SH, Cho BC. Amivantamab plus chemotherapy versus chemotherapy for first-line treatment of participants with EGFR exon 20 insertion-mutated advanced non-small cell lung cancer: PAPILLON Asia subgroup analysis. Lung Cancer. 2026 Mar;213:109302. doi: 10.1016/j.lungcan.2026.109302. Epub 2026 Feb 2. |
| 41184595 | Derived | Sanborn RE, Zhou C, Tang KJ, Cho BC, Cheng S, Popat S, Ono A, Lu S, Majem M, Aguilar A, Del Rosario Garcia Campelo M, Hayashi H, Lee KY, Lee SH, Delmonte A, Alatorre-Alexander J, Richardson G, Santos V, Dooms C, Sabari JK, Shu CA, Girard N, Mansfield AS, Park K, Xia Y, Bhattacharya A, Buyukkaramikli N, Perualila N, Diels J, Acharya S, Chandler C, Proskorovsky I, Dearden L, Wortman-Vayn H, Mahadevia PJ, Knoblauch RE, Agrawal T, Baig M, Felip E. Amivantamab-Chemotherapy in Non-Small Cell Lung Cancer with EGFR Exon 20 Insertions: Impact of Treatment Crossover and Other Endpoints from the Phase III PAPILLON Study. Target Oncol. 2025 Nov;20(6):979-989. doi: 10.1007/s11523-025-01182-0. Epub 2025 Nov 3. |
| 40922529 | Derived | Kitazono S, Ono A, Kawamura T, Hataji O, Tanaka H, Matsumoto S, Watanabe N, Nagashima H, Oki M, Takahashi M, Anazawa T, Shirai T, Yamashita A, Wortman-Vayn H, Bhattacharya A, Agrawal T, Baig M, Knoblauch RE, Hayashi H. Amivantamab Plus Chemotherapy in Japanese Patients With EGFR Exon 20 Insertions NSCLC. Cancer Sci. 2025 Nov;116(11):3139-3148. doi: 10.1111/cas.70180. Epub 2025 Sep 8. |
| 37870976 | Derived | Zhou C, Tang KJ, Cho BC, Liu B, Paz-Ares L, Cheng S, Kitazono S, Thiagarajan M, Goldman JW, Sabari JK, Sanborn RE, Mansfield AS, Hung JY, Boyer M, Popat S, Mourao Dias J, Felip E, Majem M, Gumus M, Kim SW, Ono A, Xie J, Bhattacharya A, Agrawal T, Shreeve SM, Knoblauch RE, Park K, Girard N; PAPILLON Investigators. Amivantamab plus Chemotherapy in NSCLC with EGFR Exon 20 Insertions. N Engl J Med. 2023 Nov 30;389(22):2039-2051. doi: 10.1056/NEJMoa2306441. Epub 2023 Oct 21. |
| FG001 | Arm A: Amivantamab + Chemotherapy | Participants received amivantamab 1400 milligrams (mg) (1750 mg if body weight is greater than or equal to (>=) 80 kilograms [kg]) by IV infusion once weekly starting from Cycle 1 Day 1 up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is >=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3 up to Cycle 5 Day 1. Participants received chemotherapy with pemetrexed 500 mg/m^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 milligrams per milliliter (mg/mL) per minute (AUC 5) was administered as an IV infusion on Day 1, for up to 4 cycles, and then as maintenance monotherapy until disease progression. Following the primary analysis, the study was transitioned to an OLE phase, and participants continued to receive amivantamab plus chemotherapy in the OLE phase. |
| Treated |
|
| COMPLETED | As per protocol, participants who died were also considered as completed. |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm B: Chemotherapy Alone | Participants received chemotherapy with pemetrexed 500 milligrams per meter square (mg/m^2) Intraveous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 (AUC 5) IV infusion administered on Day 1 for up to 4 cycles, and then as maintenance monotherapy until disease progression. Following the primary analysis, the study was transitioned to an open-label extension (OLE) phase, and participants either continued to receive the chemotherapy or crossover to amivantamab in the OLE phase. |
| BG001 | Arm A: Amivantamab + Chemotherapy | Participants received amivantamab 1400 milligrams (mg) (1750 mg if body weight is greater than or equal to (>=) 80 kilograms [kg]) by IV infusion once weekly starting from Cycle 1 Day 1 up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is >=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3 up to Cycle 5 Day 1. Participants received chemotherapy with pemetrexed 500 mg/m^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 milligrams per milliliter (mg/mL) per minute (AUC 5) was administered as an IV infusion on Day 1, for up to 4 cycles, and then as maintenance monotherapy until disease progression. Following the primary analysis, the study was transitioned to an OLE phase, and participants continued to receive amivantamab plus chemotherapy in the OLE phase. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR) | PFS was defined as the time from randomization until the date of objective disease progression based on BICR using RECIST version 1.1 or death (by any cause) in the absence of progression, whichever came first. Participants who have not progressed or have not died at the time of analysis were censored at the time of the latest date of their last evaluable RECIST version 1.1 assessment. Pharmacodynamic: Sum of diameters increased by greater than or equal to (>=)20 percent (%) and >=5 millimeter (mm) from nadir (including baseline if it was smallest sum). | Full analysis set included all randomized participants, classified according to their assigned treatment arm regardless of the actual treatment received. | Posted | Median | 95% Confidence Interval | Months | From randomization to either disease progression or death whichever occurs first (up to 29 months) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | Not Posted | Jan 2027 | Up to 5 years 3 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) | Not Posted | Jan 2027 | Up to 5 years 3 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Not Posted | Jan 2027 | Up to 5 years 3 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Subsequent Therapy (TST) | Not Posted | Jan 2027 | Up to 5 years 3 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival After First Subsequent Therapy (PFS2) | Not Posted | Jan 2027 | Up to 5 years 3 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Symptomatic Progression (TTSP) | Not Posted | Jan 2027 | Up to 5 years 3 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Treatment-emergent Adverse Events (TEAEs) | Not Posted | Jan 2027 | From Day 1 to 5 years 2 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants TEAEs With Severity | Not Posted | Jan 2027 | From Day 1 to 5 years 2 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinical Laboratory Abnormalities | Not Posted | Jan 2027 | Up to 5 years 3 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Vital Signs Abnormalities | Not Posted | Jan 2027 | Up to 5 years 3 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Physical Examination Abnormalities | Not Posted | Jan 2027 | Up to 5 years 3 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Concentration of Amivantamab | Not Posted | Jan 2027 | Day 1 (Cycles 1, 2, 3, 5, 7, 9, 11, 13), Day 2 (Cycle 1) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-Amivantamab Antibodies | Not Posted | Jan 2027 | Day 1 (Cycles 1, 2, 3, 5, 7, 9, 11, 13), Day 2 (Cycle 1) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) | Not Posted | Jan 2027 | From baseline to 5 years 3 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) | Not Posted | Jan 2027 | From baseline to 5 years 3 months | Participants |
From baseline (Day 1 of Cycle 1) up to 29 months
The safety set included all randomized participants who received at least 1 dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm B: Chemotherapy Alone | Participants received chemotherapy with pemetrexed 500 milligrams per meter square (mg/m^2) Intraveous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 (AUC 5) IV infusion administered on Day 1 for up to 4 cycles, and then as maintenance monotherapy until disease progression. Following the primary analysis, the study was transitioned to an open-label extension (OLE) phase, and participants either continued to receive the chemotherapy or crossover to amivantamab in the OLE phase. | 42 | 155 | 48 | 155 | 149 | 155 |
| EG001 | Arm A: Amivantamab + Chemotherapy | Participants received amivantamab 1400 milligrams (mg) (1750 mg if body weight is greater than or equal to (>=) 80 kilograms [kg]) by IV infusion once weekly starting from Cycle 1 Day 1 up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is >=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3 up to Cycle 5 Day 1. Participants received chemotherapy with pemetrexed 500 mg/m^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin area under the concentration-time curve of 5 milligrams per milliliter (mg/mL) per minute (AUC 5) was administered as an IV infusion on Day 1, for up to 4 cycles, and then as maintenance monotherapy until disease progression. Following the primary analysis, the study was transitioned to an OLE phase, and participants continued to receive amivantamab plus chemotherapy in the OLE phase. | 28 | 151 | 56 | 151 | 151 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rash Pustular | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Covid-19 Pneumonia | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pneumonia Viral | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Postoperative Wound Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Enterocolitis Infectious | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Lower Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Myoclonic Epilepsy | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Depressed Level of Consciousness | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Lacunar Infarction | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Vertebrobasilar Insufficiency | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| C-Reactive Protein Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Lumbar Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Incisional Hernia | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Endometrial Thickening | Reproductive system and breast disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Ovarian Mass | Reproductive system and breast disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Biliary Obstruction | Hepatobiliary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Jaundice Cholestatic | Hepatobiliary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Contrast Media Reaction | Immune system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cancer Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA Version 25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Mouth Ulceration | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Gingival Bleeding | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Lacrimation Increased | Eye disorders | MedDRA Version 25.0 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Medical Director | Janssen Research & Development | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 4, 2021 | May 1, 2024 | SAP_001.pdf |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718215 | amivantamab |
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| BELGIUM |
|
| BRAZIL |
|
| CANADA |
|
| CHINA |
|
| FRANCE |
|
| GERMANY |
|
| HUNGARY |
|
| INDIA |
|
| ISRAEL |
|
| ITALY |
|
| JAPAN |
|
| MALAYSIA |
|
| MEXICO |
|
| POLAND |
|
| PORTUGAL |
|
| RUSSIAN FEDERATION |
|
| SOUTH KOREA |
|
| SPAIN |
|
| TAIWAN |
|
| THAILAND |
|
| TURKEY |
|
| UNITED KINGDOM |
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| UNITED STATES |
|