Lung Cancer Clinical Trial
A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions
Summary
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.
Full Description
Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer (almost 20 percent [%] of cancer deaths); NSCLC accounts for 80% to 85% of lung cancers. Amivantamab (JNJ-61186372) is a low fucose, fully human immunoglobulin G1 (IgG1)-based bispecific antibody directed against epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET) tyrosine kinase receptors that is being developed for the treatment of solid tumors. The hypothesis is that amivantamab, when given in combination with standard of care carboplatin-pemetrexed chemotherapy, will prolong PFS compared with carboplatin-pemetrexed in patients with locally advanced or metastatic NSCLC characterized by EGFR Exon 20ins activating mutations. The study will include a Screening phase (28 days), a Treatment phase (from Cycle 1 Day 1 [21-day cycle] till end of treatment [30 days after last dose]) and a Follow up phase (from the end of treatment visit and until the end of study, death, loss to follow-up, or withdrawal of consent from participation in the study, whichever comes first). An independent data monitoring committee (IDMC) will be commissioned for the periodic review of safety and tolerability data, as well as planned efficacy analyses. Efficacy assessments will include disease assessment, symptomatic progression and patient-reported outcome. Safety assessments will include physical examinations, vital signs, electrocardiograms (ECGs), Eastern Cooperative Oncology Group (ECOG) performance status and clinical safety laboratory assessments (serum chemistry, hematology, coagulation, and urinalysis). The total duration of the study is up to 48 months.
Eligibility Criteria
Inclusion Criteria:
Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation
Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream
A female participant of childbearing potential must have a negative serum or urine 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:
Participant has evidence of synchronous NSCLC disease (as suggested by genetic characterization or radiographic appearance)
Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible)
Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation
Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis
Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid
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There are 275 Locations for this study
Yuma Arizona, 85364, United States
Duarte California, 91010, United States
Duarte California, 91010, United States
Fountain Valley California, 92708, United States
La Jolla California, 92093, United States
Orange California, 92868, United States
Santa Monica California, 90404, United States
Aurora Colorado, 80045, United States
Washington District of Columbia, 20007, United States
Jacksonville Florida, 32224, United States
Ocala Florida, 34474, United States
Tampa Florida, 33612, United States
Athens Georgia, 30607, United States
Honolulu Hawaii, 96813, United States
Peoria Illinois, 61615, United States
Fort Wayne Indiana, 46825, United States
South Bend Indiana, 46601, United States
Covington Louisiana, 70433, United States
Metairie Louisiana, 70006, United States
Bethesda Maryland, 20817, United States
Frederick Maryland, 21702, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Rochester Minnesota, 55905, United States
Jackson Mississippi, 39216, United States
Bolivar Missouri, 65613, United States
Saint Louis Missouri, 63110, United States
Las Vegas Nevada, 89169, United States
Belleville New Jersey, 07109, United States
East Brunswick New Jersey, 08816, United States
New York New York, 10016, United States
New York New York, 10029, United States
New York New York, 10032, United States
New York New York, 10065, United States
Durham North Carolina, 27705, United States
Cincinnati Ohio, 45220, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43214, United States
Tulsa Oklahoma, 74146, United States
Portland Oregon, 97213, United States
Sioux Falls South Dakota, 57104, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Tyler Texas, 75702, United States
Salt Lake City Utah, 84106, United States
Salt Lake City Utah, 84112, United States
Fairfax Virginia, 22031, United States
Salem Virginia, 24153, United States
Tacoma Washington, 98405, United States
Camperdown , 2050, Australia
Heidelberg , 3084, Australia
Kogarah , 2217, Australia
Malvern , 3144, Australia
Nedlands , 6009, Australia
Leuven , 3000, Belgium
Roeselare , 8800, Belgium
Yvoir , 5530, Belgium
Barretos , 14784, Brazil
Belo Horizonte , 30110, Brazil
Cachoeiro de Itapemirim , 29308, Brazil
Florianopolis , 88020, Brazil
Ijui , 98700, Brazil
Natal , 59062, Brazil
Pelotas , 96020, Brazil
Porto Alegre , 90020, Brazil
Porto Alegre , 90610, Brazil
Rio De Janeiro , 20231, Brazil
Rio de Janeiro , 22250, Brazil
Rio de Janeiro , 22281, Brazil
Sao Paulo , 01246, Brazil
Sao Paulo , 01509, Brazil
Sao Paulo , 04014, Brazil
Sorocaba , 18030, Brazil
Edmonton Alberta, T6G 1, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H4A 3, Canada
Beijing , 10014, China
Beijing , 10085, China
Beijing , 10119, China
Beijing , 10220, China
Changchun , 13000, China
Changsha , 41001, China
Changzhou , 21300, China
Chengdu , 61004, China
Chongqing , 40003, China
Fuzhou , 35000, China
Guang Zhou , 51008, China
Hang Zhou , 31002, China
Hangzhou , 31000, China
Hangzhou , 31000, China
Hangzhou , 31001, China
Harbin , 15008, China
Linhai , 31700, China
Nanjing , 21003, China
Shanghai , 20003, China
Shanghai , 20003, China
ShangHai , 20003, China
Shanghai , 20012, China
Shanghai , 20043, China
Shenyang , 11000, China
Shenzhen , 51811, China
Tianjin , 30005, China
Weifang , 26100, China
Wuhan , 43003, China
Wuxi , 21412, China
Xi'an , 71006, China
Yantai , 26400, China
Zhengzhou , 45000, China
Bordeaux , 33000, France
Bron , 69500, France
Dijon , 21000, France
le mans Cedex 9 , 72037, France
Lille CEDEX , 59037, France
NANTES cedex 1 , 44093, France
Paris , 75005, France
Pessac , 33604, France
Saint Mande , 94163, France
Bad Berka , 99437, Germany
Berlin , 13125, Germany
Gauting , 82131, Germany
Heidelberg , 69126, Germany
Heilbronn , 74072, Germany
Hemer , 58675, Germany
Koeln , 50937, Germany
Koeln , 51109, Germany
Moers , 47441, Germany
Oldenburg , 26121, Germany
Recklinghausen , 45659, Germany
Budapest , H-152, Hungary
Farkasgyepü , 8582, Hungary
Gyöngyös , 3233, Hungary
Szekesfehervar , 8000, Hungary
Szombathely , 9700, Hungary
Torokbalint , 2045, Hungary
Hyderabad , 50003, India
Kolkata , 70016, India
Mumbai , 40001, India
Nasik , 42200, India
New Delhi , 11008, India
Pune , 41101, India
Beersheba , 85101, Israel
Jerusalem , 91031, Israel
Jerusalem , 91120, Israel
Kfar Saba , 44281, Israel
Petah Tikva , 49100, Israel
Tel-Aviv , 64239, Israel
Bologna , 40138, Italy
Catania , 95123, Italy
Meldola , 47014, Italy
Milano , 20122, Italy
Milano , 20132, Italy
Milano , 20133, Italy
Monza , 20052, Italy
Ravenna , 48121, Italy
Roma , 00168, Italy
Rozzano , 20089, Italy
Bunkyo-Ku , 113-8, Japan
Habikino , 583-8, Japan
Hidaka , 350-1, Japan
Himeji , 670-8, Japan
Hirakata , 573-1, Japan
Hyogo , 673-8, Japan
Kanazawa , 920-8, Japan
Kashiwa , 277-8, Japan
Kishiwada , 596-8, Japan
Kobe , 650-0, Japan
Kurashiki , 710-8, Japan
Kurume , 830-0, Japan
Matsusaka , 515-8, Japan
Nagoya-shi , 460-0, Japan
Nagoya-Shi , 464-8, Japan
Niigata , 951-8, Japan
Osaka-Sayama-shi , 589-8, Japan
Sagamihara , 252-0, Japan
Sapporo-shi , 060-8, Japan
Shiwa-gun , 028-3, Japan
Shizuoka , 411-8, Japan
Tokyo , 135-8, Japan
Toon-shi , 791-0, Japan
Wakayama , 641-8, Japan
Yamaguchi , 755-0, Japan
Busan , 48108, Korea, Republic of
Gyeonggi-do , 10408, Korea, Republic of
Gyeonggi-do , 13620, Korea, Republic of
Gyeongsangnam-do , 52727, Korea, Republic of
Jeollanam-do , 58128, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03181, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
George Town , 10990, Malaysia
Johor Bahru , 81100, Malaysia
Kuala Lumpur , 50586, Malaysia
Kuala Lumpur , 59100, Malaysia
Chihuahua , 31217, Mexico
Ciudad de Mexico , 03100, Mexico
Ciudad de Mexico , 14050, Mexico
Ciudad de Mexico , 14080, Mexico
Guadalajara , 44280, Mexico
Mexico , 03100, Mexico
Monterrey , 64710, Mexico
Naucalpan , 53100, Mexico
Bydgoszcz , 85-79, Poland
Gdansk , 80-21, Poland
Gdynia , 81-51, Poland
Olsztyn , 10-35, Poland
Poznan , 60-69, Poland
Warszawa , 02-78, Poland
Coimbra , 3045 , Portugal
Lisboa , 1400-, Portugal
Lisboa , 1998-, Portugal
Lisboa , G1R 2, Portugal
Porto , 4099-, Portugal
Porto , 4200-, Portugal
Vila Nova de Gaia , 4434-, Portugal
Rio Piedras , 00935, Puerto Rico
Irkutsk , 66403, Russian Federation
Kazan , 42002, Russian Federation
Krasnogorsk , 14342, Russian Federation
Krasnoyarsk , 66013, Russian Federation
Kuzmolovsky , 18866, Russian Federation
Moscow , 11547, Russian Federation
Moscow , 11553, Russian Federation
Moscow , 12135, Russian Federation
Nalchik , 36000, Russian Federation
Nizhniy Novgorod , 60300, Russian Federation
Saint Petersburg , 19775, Russian Federation
Saint-Petersburg , 19429, Russian Federation
St-Petersburg , 19600, Russian Federation
St. Petersburg , 19825, Russian Federation
Tomsk , 63405, Russian Federation
Ufa , 45008, Russian Federation
Yaroslavl , 15005, Russian Federation
A Coruña , 15006, Spain
Badalona , 08916, Spain
Barcelona , 08025, Spain
Barcelona , 08028, Spain
Barcelona , 08035, Spain
Burgos , 09006, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Majadahonda , 28222, Spain
Málaga , 29010, Spain
Pamplona , 31008, Spain
Seville , 41013, Spain
Zaragoza , 50009, Spain
Kaohsiung , 807, Taiwan
Kaohsiung , 833, Taiwan
New Taipei , 23561, Taiwan
Taichung , 402, Taiwan
Taichung , 40447, Taiwan
Taipei City , 10002, Taiwan
Bangkok , 10400, Thailand
Bangkok , 10700, Thailand
Songkla , 90110, Thailand
Adana , 01060, Turkey
Adana , 01250, Turkey
Ankara , 6560, Turkey
Ankara , 6800, Turkey
Edirne , 22030, Turkey
Istanbul , 34098, Turkey
Istanbul , 34214, Turkey
Istanbul , 34722, Turkey
Izmir , 35580, Turkey
Dnipro , 49102, Ukraine
Kyiv , 02091, Ukraine
Kyiv , 03022, Ukraine
Odesa , 65010, Ukraine
Uzhgorod , 88000, Ukraine
Edinburgh , EH4 2, United Kingdom
London , SW3 6, United Kingdom
Nottingham , NG5 1, United Kingdom
Sutton , SM2 5, United Kingdom
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