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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3475-789 | Other Identifier | MSD | |
| 184019 | Registry Identifier | JAPIC | |
| 2017-004188-11 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib [TAGRISSO®] failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status.
The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy in terms of: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This study will be considered to have met its success criteria if the combination of pembrolizumab plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS.
Upon study completion, participants are discontinued and may be enrolled in a pembrolizumab extension study, if available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembro+Pemetrexed+Chemo | Experimental | Participants receive pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W with no restrictions on the number of cycles PLUS platinum chemotherapy (chemo) (either carboplatin Area Under the Curve [AUC] 5 via IV infusion Q3W for 4 cycles [Cycles 1-4] or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles [Cycles 1-4]). |
|
| Placebo+Pemetrexed+Chemo | Active Comparator | Participants receive normal saline solution via IV infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W with no restrictions on the number of cycles PLUS platinum chemotherapy (chemo)(either carboplatin AUC 5 via IV infusion Q3W for 4 cycles [Cycles 1-4] or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles [Cycles 1-4]). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pembrolizumab | Biological | IV infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PFS was assessed by blinded independent central review (BICR) using RECIST 1.1. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions is also considered PD. The PFS presented was analyzed using the product-limit (Kaplan-Meier) method for censored data. | Up to ~40 months |
| Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis will be censored at the date of the last follow-up. The OS presented was analyzed using the product-limit (Kaplan-Meier) method for censored data. | Up to ~51 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per RECIST 1.1 | ORR was assessed by BICR using RECIST 1.1. ORR is defined as the percentage of participants in the analysis population who experience a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The ORR for participants is presented. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center ( Site 0070) | Los Angeles | California | 90048 | United States | ||
| Pacific Cancer Care ( Site 0058) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39173098 | Result | Yang JC, Lee DH, Lee JS, Fan Y, de Marinis F, Iwama E, Inoue T, Rodriguez-Cid J, Zhang L, Yang CT, de la Mora Jimenez E, Zhou J, Perol M, Lee KH, Vicente D, Ichihara E, Riely GJ, Luo Y, Chirovsky D, Pietanza MC, Bhagwati N, Lu S. Phase III KEYNOTE-789 Study of Pemetrexed and Platinum With or Without Pembrolizumab for Tyrosine Kinase Inhibitor-Resistant, EGFR-Mutant, Metastatic Nonsquamous Non-Small Cell Lung Cancer. J Clin Oncol. 2024 Dec;42(34):4029-4039. doi: 10.1200/JCO.23.02747. Epub 2024 Aug 22. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pembro + Pemetrexed + Chemo | Participants received pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W with no restrictions on the number of cycles PLUS platinum chemotherapy (chemo) (either carboplatin Area Under the Curve [AUC] 5 via IV infusion Q3W for 4 cycles [Cycles 1-4] or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles [Cycles 1-4]). |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2023 |
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| pemetrexed | Drug | IV infusion |
|
| carboplatin | Drug | IV infusion |
|
| cisplatin | Drug | IV infusion |
|
| saline solution | Drug | IV infusion |
|
|
| Up to ~51 months |
| Duration of Response (DOR) Per RECIST 1.1 | DOR was assessed by BICR using RECIST 1.1. For participants who experience a response of CR or PR, DOR is defined as the time from the earliest date of qualifying response until earliest date of PD or death from any cause, whichever comes first. The DOR presented was analyzed using the product-limit (Kaplan-Meier) method for censored data. | Up to ~51 months |
| Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score | The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are each scored on a 7-point scale (1=Very poor to 7=Excellent). The two raw scores were averaged into a combined score, then normalized using linear transformation so each participant's score ranged from 0 to 100 (0=Worst overall health/quality of life and 100=Best overall health/quality of life). The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score is presented. | Baseline and Week 18 |
| Time to True Deterioration (TTD) in the EORTC Questionnaire Composite Endpoint of Cough, Chest Pain or Dyspnea | TTD is the time from baseline to first onset of 10 points or more deterioration from baseline with confirmation by the subsequent visit of 10 points or more deterioration from baseline in the composite endpoint of cough [EORTC QLQ-Lung Cancer Module 13 (LC13) Item 1; How much did you cough?], chest pain [EORTC QLQ-LC13 Item 10; Have you had pain in your chest?], or dyspnea [EORTC QLQ-C30 Item 8; Were you short of breath?]. Individual responses are given on a 4-point scale (1=Not at all; 4=Very much), with a lower score indicating a better outcome. The TTD was analyzed using the product-limit (Kaplan-Meier) method for censored data. The time to true deterioration in the composite endpoint of cough, chest pain or dyspnea is presented. | Baseline and up to ~51 months |
| Percentage of Participants Who Experienced an Adverse Event (AE) | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The percentage of participants who experienced an AE is presented. | Up to ~44 months |
| Percentage of Participants Who Discontinued Study Treatment Due to AEs | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The percentage of participants who discontinued study treatment due to an adverse event is presented. | Up to ~41 months |
| Monterey |
| California |
| 93940 |
| United States |
| UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0092) | Orange | California | 92868 | United States |
| St. Joseph Heritage Healthcare ( Site 0003) | Santa Rosa | California | 95403 | United States |
| North Shore University Health System ( Site 0030) | Evanston | Illinois | 60201 | United States |
| Siouxland Regioinal Cancer Center dba June E. Nylen Cancer Center ( Site 0065) | Sioux City | Iowa | 51101 | United States |
| Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 0048) | Edina | Minnesota | 55435 | United States |
| Saint Lukes Hospital of Kansas City ( Site 0060) | Kansas City | Missouri | 64111 | United States |
| New York Oncology Hematology P.C ( Site 8000) | Albany | New York | 12208 | United States |
| Monter Cancer Center ( Site 0054) | Lake Success | New York | 11042 | United States |
| Memorial Sloan Kettering Cancer Center-Rockerfeller Patient Pavilion ( Site 0049) | New York | New York | 10022 | United States |
| White Plains Hospital Center for Cancer Care ( Site 0014) | White Plains | New York | 10601 | United States |
| Providence Portland Medical Center ( Site 0097) | Portland | Oregon | 97213 | United States |
| Kaiser Permanente Northwest ( Site 0037) | Portland | Oregon | 97227 | United States |
| Parkland Health & Hospital System ( Site 2102) | Dallas | Texas | 75235 | United States |
| University of Texas Southwestern Medical Center at Dallas ( Site 0035) | Dallas | Texas | 75390 | United States |
| Utah Cancer Specialists ( Site 0001) | Salt Lake City | Utah | 84106 | United States |
| Emily Couric Clinical Cancer Center ( Site 0020) | Charlottesville | Virginia | 22903 | United States |
| Froedtert Hospital & the Medical College of Wisconsin ( Site 0041) | Milwaukee | Wisconsin | 53226 | United States |
| Chris OBrien Lifehouse ( Site 0200) | Camperdown | New South Wales | 2050 | Australia |
| Westmead Hospital ( Site 0201) | Westmead | New South Wales | 2145 | Australia |
| Eastern Health ( Site 0202) | Box Hill | Victoria | 3128 | Australia |
| Austin Health ( Site 0203) | Heidelberg | Victoria | 3084 | Australia |
| Liga Norte Riograndense Contra o Cancer ( Site 1909) | Natal | Rio Grande do Norte | 59075-740 | Brazil |
| Hospital de Caridade de Ijui ( Site 1907) | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Hospital Bruno Born ( Site 1913) | Lajeado | Rio Grande do Sul | 95900-010 | Brazil |
| Hospital de Clinicas de Porto Alegre ( Site 1905) | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1904) | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1911) | Barretos | São Paulo | 14784-400 | Brazil |
| Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1912) | Ribeirão Preto | São Paulo | 14048-900 | Brazil |
| Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 1903) | São Paulo | 01246-000 | Brazil |
| William Osler Health System ( Site 0100) | Brampton | Ontario | L6R 3J7 | Canada |
| Sunnybrook Health Sciences, Odette Cancer Centre ( Site 0102) | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Cancer Centre ( Site 0104) | Toronto | Ontario | M5G 2M9 | Canada |
| Jewish General Hospital ( Site 0105) | Montreal | Quebec | H3T 1E2 | Canada |
| The First Affiliated Hospital of Anhui Medical University ( Site 0721) | Hefei | Anhui | 230088 | China |
| Cancer Hospital Chinese Academy of Medical Sciences ( Site 0717) | Beijing | Beijing Municipality | 100021 | China |
| Peking Union Medical College Hospital ( Site 0703) | Beijing | Beijing Municipality | 100032 | China |
| Beijing Cancer Hospital ( Site 0718) | Beijing | Beijing Municipality | 100036 | China |
| Southwest Hospital, The Third Military Medical University ( Site 0725) | Chongqing | Chongqing Municipality | 400038 | China |
| Fujian Cancer Hospital ( Site 0723) | Fuzhou | Fujian | 350014 | China |
| The Affiliated Tumour Hospital of Harbin Medical University ( Site 0706) | Harbin | Heilongjiang | 150081 | China |
| Henan Cancer Hospital ( Site 0711) | Zhengzhou | Henan | 450008 | China |
| Xiangya Hospital of Central South University ( Site 0710) | Changsha | Hunan | 410008 | China |
| Hunan Cancer Hospital ( Site 0722) | Changsha | Hunan | 410013 | China |
| Jiangsu Cancer Hospital ( Site 0719) | Nanjing | Jiangsu | 210000 | China |
| The First Hospital of Jilin University ( Site 0702) | Changchun | Jilin | 130021 | China |
| Jilin Cancer Hospital ( Site 0705) | Changchun | Jilin | 130103 | China |
| Shanghai Chest Hospital ( Site 0700) | Shanghai | Shanghai Municipality | 200030 | China |
| Zhongshan Hospital Fudan University ( Site 0712) | Shanghai | Shanghai Municipality | 200433 | China |
| Tangdu Hospital ( Site 0708) | Xi’an | Shanxi | 710038 | China |
| The First Affiliated Hospital of Xi an Jiaotong University ( Site 0709) | Xi’an | Shanxi | 710061 | China |
| Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0701) | Ürümqi | Xinjiang | 830000 | China |
| The First Affiliated Hospital.Zhejiang University ( Site 0713) | Hangzhou | Zhejiang | 310003 | China |
| Sir Run Run Shaw Hospital School of Medicine, Zhejiang University ( Site 0715) | Hangzhou | Zhejiang | 310016 | China |
| Zhejiang Cancer Hospital ( Site 0716) | Hangzhou | Zhejiang | 310022 | China |
| Centre Leon Berard ( Site 0801) | Lyon | Auvergne | 69008 | France |
| CHU Caen Service de Pneumologie ( Site 0804) | Caen | Calvados | 14033 | France |
| Centre Georges Francois Leclerc ( Site 0809) | Dijon | Cote-d'Or | 21000 | France |
| Hopital Jean Minjoz Besancon ( Site 0805) | Besançon | Doubs | 25030 | France |
| Hopital Prive d'Antony ( Site 0811) | Antony | Hauts-de-Seine | 92160 | France |
| C.H.U. de Tours - Hopital Bretonneau ( Site 0806) | Tours | Indre-et-Loire | 37044 | France |
| Centre D Oncologie de Gentilly ( Site 0810) | Nancy | Meurthe-et-Moselle | 54100 | France |
| Clinique Victor Hugo ( Site 0802) | Le Mans | Sarthe | 72000 | France |
| CHU Poitiers ( Site 0803) | Poitiers | Vienne | 86021 | France |
| Robert Bosch Krankenhaus Klinik Schillerhoehe ( Site 0904) | Gerlingen | Baden-Wurttemberg | 70839 | Germany |
| Universitaetsklinikum Mannheim ( Site 0911) | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Klinikum Wuerzburg Mitte gGmbH ( Site 0901) | Würzburg | Bavaria | 97074 | Germany |
| Pius Hospital Oldenburg ( Site 0905) | Oldenburg | Lower Saxony | 26121 | Germany |
| Florence Nightingale Krankenhaus ( Site 0912) | Düsseldorf | North Rhine-Westphalia | 40489 | Germany |
| Kliniken Essen-Mitte ( Site 0900) | Essen | North Rhine-Westphalia | 45136 | Germany |
| Universitaetsklinikum Muenster ( Site 0906) | Münster | North Rhine-Westphalia | 48149 | Germany |
| Medizinische Fakultaet Carl Gustav Carus der TU Dresden ( Site 0907) | Dresden | Saxony | 01307 | Germany |
| Asklepios Klinikum Hamburg ( Site 0908) | Hamburg | 21075 | Germany |
| Hong Kong Integrated Oncology Centre ( Site 0304) | Hong Kong | Hong Kong |
| Queen Mary Hospital ( Site 0301) | Hong Kong | Hong Kong |
| Queen Mary Hospital ( Site 0303) | Hong Kong | Hong Kong |
| Hong Kong United Oncology Centre ( Site 0306) | Kowloon | Hong Kong |
| Tuen Mun Hospital ( Site 0305) | Tuenmen | Hong Kong |
| Meir Medical Center ( Site 1701) | Kfar Saba | Central District | 4428164 | Israel |
| Rabin Medical Center ( Site 1704) | Petah Tikva | Central District | 4941492 | Israel |
| Rambam Medical Center ( Site 1703) | Haifa | Heifa | 3109601 | Israel |
| Ha Emek Medical Center ( Site 1707) | Afula | Northern District | 1834111 | Israel |
| Barzilai Medical Center ( Site 1706) | Ashkelon | Southern District | 7830604 | Israel |
| Soroka Medical Center ( Site 1702) | Beersheba | Southern District | 8457108 | Israel |
| Chaim Sheba Medical Center. ( Site 1700) | Ramat Gan | Tell Abib | 5265601 | Israel |
| Sourasky Medical Center ( Site 1705) | Tel Aviv | Tell Abib | 6423906 | Israel |
| Istituto Europeo di Oncologia ( Site 1303) | Milan | Lombardy | 20141 | Italy |
| Ospedale San Vincenzo di Taormina ( Site 1302) | Taormina | Messina | 98039 | Italy |
| AOU San Luigi Gonzaga di Orbassano ( Site 1300) | Orbassano | Torino | 10043 | Italy |
| IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1305) | Bari | 70124 | Italy |
| Azienda Ospedaliero Universitaria Careggi ( Site 1301) | Florence | 50134 | Italy |
| Azienda Ospedaliera dei Colli V. Monaldi ( Site 1306) | Naples | 80131 | Italy |
| Universita Campus Bio-Medico di Roma ( Site 1304) | Roma | 00128 | Italy |
| National Hospital Organization Nagoya Medical Center ( Site 0608) | Nagoya | Aichi-ken | 460-0001 | Japan |
| Aichi Cancer Center Hospital ( Site 0612) | Nagoya | Aichi-ken | 464-8681 | Japan |
| Fujita Health University Hospital ( Site 0619) | Toyoake | Aichi-ken | 470-1192 | Japan |
| National Cancer Center Hospital East ( Site 0601) | Kashiwa | Chiba | 277-8577 | Japan |
| National Hospital Organization Shikoku Cancer Center ( Site 0616) | Matsuyama | Ehime | 791-0280 | Japan |
| Hyogo Cancer Center ( Site 0604) | Akashi | Hyōgo | 673-8558 | Japan |
| Kanazawa University Hospital ( Site 0617) | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Kanagawa Cancer Center ( Site 0609) | Yokohama | Kanagawa | 241-8515 | Japan |
| Kansai Medical University Hospital ( Site 0606) | Hirakata | Osaka | 573-1191 | Japan |
| Shizuoka Cancer Center Hospital and Research Institute ( Site 0602) | Sunto-gun | Shizuoka | 411-8777 | Japan |
| National Hospital Organization Kyushu Medical Center ( Site 0621) | Fukuoka | 810-8563 | Japan |
| Kyushu University Hospital ( Site 0605) | Fukuoka | 812-8582 | Japan |
| Niigata Cancer Center Hospital ( Site 0610) | Niigata | 951-8566 | Japan |
| Okayama University Hospital ( Site 0614) | Okayama | 700-8558 | Japan |
| Osaka International Cancer Institute ( Site 0611) | Osaka | 541-8567 | Japan |
| National Cancer Center Hospital ( Site 0603) | Tokyo | 104-0045 | Japan |
| Toranomon Hospital ( Site 0615) | Tokyo | 105-8470 | Japan |
| Tokyo Metropolitan Komagome Hospital ( Site 0618) | Tokyo | 113-8677 | Japan |
| Wakayama Medical University Hospital ( Site 0613) | Wakayama | 641-8510 | Japan |
| Instituto Jaliscience de Cancerologia ( Site 2000) | Guadalajara | Jalisco | 44280 | Mexico |
| Medica Sur S.A.B de C.V. ( Site 2003) | Mexico City | 14050 | Mexico |
| Oaxaca Site Management Organization SC ( Site 2001) | Oaxaca City | 68000 | Mexico |
| Instituto Nacional de Cancerologia. ( Site 2007) | Tlalpan | 14080 | Mexico |
| Chungbuk National University Hospital ( Site 0404) | Cheongju-si | Chungcheongbuk-do [Chungbuk] | 28644 | South Korea |
| Gachon University Gil Medical Center ( Site 0408) | Incheon | Incheon-gwangyeoksi [Incheon] | 21565 | South Korea |
| National Cancer Center ( Site 0400) | Gyeonggi-do | Kyonggi-do | 10408 | South Korea |
| Seoul National University Bundang Hospital ( Site 0405) | Seongnam-si | Kyonggi-do | 13620 | South Korea |
| Seoul National University Hospital ( Site 0402) | Seoul | Seoul-teukbyeolsi [Seoul] | 03080 | South Korea |
| Asan Medical Center ( Site 0407) | Seoul | Seoul-teukbyeolsi [Seoul] | 05505 | South Korea |
| Samsung Medical Center ( Site 0403) | Seoul | Seoul-teukbyeolsi [Seoul] | 06351 | South Korea |
| The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0406) | Seoul | Seoul-teukbyeolsi [Seoul] | 06591 | South Korea |
| Ulsan University Hospital ( Site 0401) | Ulsan | Ulsan-Kwangyokshi | 44033 | South Korea |
| Hospitalo Univ. Germans Trias i Pujol ( Site 1100) | Badalona | Barcelona [Barcelona] | 08916 | Spain |
| Hospital de la Santa Creu i Sant Pau ( Site 1102) | Barcelona | Barcelona [Barcelona] | 08025 | Spain |
| Hospital Universitari Vall d Hebron ( Site 1106) | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Hospital Ramon y Cajal ( Site 1101) | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre ( Site 1103) | Madrid | 28041 | Spain |
| Complejo Hospitalario Carlos Haya de Malaga ( Site 1107) | Málaga | 29010 | Spain |
| Hospital Universitario Virgen Macarena ( Site 1104) | Seville | 41009 | Spain |
| Linkopings Universitetssjukhus ( Site 1504) | Linköping | Ostergotlands Lan [se-05] | 581 85 | Sweden |
| Skanes Universitetssjukhus Lund ( Site 1503) | Lund | Skane Lan [se-12] | 221 85 | Sweden |
| Karolinska Universitetssjukhuset Solna ( Site 1500) | Solna | Stockholms Lan [se-01] | 171 64 | Sweden |
| Sahlgrenska Universitetssjukhuset ( Site 1502) | Gothenburg | Vastra Gotalands Lan [se-14] | 413 45 | Sweden |
| Hualien Tzu Chi Medical Center-Hospital ( Site 0510) | Hualien City | Hualien | 970 | Taiwan |
| Taipei Tzu Chi Hospital ( Site 0512) | New Taipei City | New Taipei | 231 | Taiwan |
| Changhua Christian Hospital ( Site 0509) | Changhua | 50006 | Taiwan |
| National Taiwan University Hospital Hsin-Chu Branch ( Site 0511) | Hsinchu | 300 | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital ( Site 0507) | Kaohsiung City | 833 | Taiwan |
| Taipei Medical University Shuang Ho Hospital ( Site 0508) | New Taipei City | 235 | Taiwan |
| China Medical University Hospital ( Site 0505) | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital ( Site 0504) | Taichung | 40705 | Taiwan |
| National Cheng Kung University Hospital ( Site 0506) | Tainan | 704 | Taiwan |
| National Taiwan University Hospital ( Site 0500) | Taipei | 100 | Taiwan |
| Mackay Memorial Hospital ( Site 0503) | Taipei | 104 | Taiwan |
| Taipei Veterans General Hospital ( Site 0501) | Taipei | 11217 | Taiwan |
| Chang Gung Medical Foundation. Linkou ( Site 0502) | Taoyuan | 333 | Taiwan |
| Sussex University Hospitals ( Site 1003) | Brighton | Brighton And Hove | BN2 5BE | United Kingdom |
| Western General Hospital ( Site 1009) | Edinburgh | Edinburgh, City of | EH4 2XU | United Kingdom |
| Leicester Royal Infirmary ( Site 1000) | Leicester | Leicestershire | LE1 5WW | United Kingdom |
| University College London Hospitals NHS Foundation Trust ( Site 1006) | London | London, City of | NW1 2PG | United Kingdom |
| Chelsea & Westminster Hospital ( Site 1001) | London | London, City of | SW10 9NH | United Kingdom |
| Birmingham Heartlands Hospital ( Site 1002) | Birmingham | B9 5SS | United Kingdom |
| St James s University Hospital ( Site 1008) | Leeds | LS9 7TF | United Kingdom |
| Barking Havering and Redbridge University Hospitals NHS Trust Queen s Hospital ( Site 1004) | Romford | RM7 0AG | United Kingdom |
| Plain Language Summary | View source |
| FG001 | Placebo + Pemetrexed + Chemo | Participants received normal saline solution via IV infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W with no restrictions on the number of cycles PLUS platinum chemotherapy (chemo)(either carboplatin AUC 5 via IV infusion Q3W for 4 cycles [Cycles 1-4] or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles [Cycles 1-4]). Eligible participants who had BICR-verified progressive disease were eligible to switch over to pembrolizumab monotherapy 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles. |
| Treated |
|
| Switched Over to Pembro Monotherapy |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pembro + Pemetrexed + Chemo | Participants received pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W with no restrictions on the number of cycles PLUS platinum chemotherapy (chemo) (either carboplatin Area Under the Curve [AUC] 5 via IV infusion Q3W for 4 cycles [Cycles 1-4] or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles [Cycles 1-4]). |
| BG001 | Placebo + Pemetrexed + Chemo | Participants received normal saline solution via IV infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W with no restrictions on the number of cycles PLUS platinum chemotherapy (chemo)(either carboplatin AUC 5 via IV infusion Q3W for 4 cycles [Cycles 1-4] or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles [Cycles 1-4]). Eligible participants who had BICR-verified progressive disease were eligible to switch over to pembrolizumab monotherapy 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles. |
| 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 |
| ||||||||||||||||
| Geographic Region | Participants were stratified by geographic area of the enrolling site: East Asia versus Non-East Asia | Number | Count of Participants |
| |||||||||||||||
| Programmed Death Ligand 1 (PD-L1) Status | Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue from a newly obtained biopsy. PD-L1 status is determined by tumor proportion score (TPS). Participants with a TPS ≥50% were classified as PD-L1 strongly positive and participants with a TPS <50% were classified as not strongly positive. | Number | Count of Participants |
| |||||||||||||||
| Previous use of Tyrosine Kinase Inhibitor (TKI) Treatment History with Osimertinib | Participants were stratified using previous treatment history with TKI osimertinib: osimertinib or no osimertinib. | Number | Count of 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) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PFS was assessed by blinded independent central review (BICR) using RECIST 1.1. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions is also considered PD. The PFS presented was analyzed using the product-limit (Kaplan-Meier) method for censored data. | All randomized participants | Posted | Median | 95% Confidence Interval | Months | Up to ~40 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis will be censored at the date of the last follow-up. The OS presented was analyzed using the product-limit (Kaplan-Meier) method for censored data. | All randomized participants | Posted | Median | 95% Confidence Interval | Months | Up to ~51 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) Per RECIST 1.1 | ORR was assessed by BICR using RECIST 1.1. ORR is defined as the percentage of participants in the analysis population who experience a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The ORR for participants is presented. | All randomized participants | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to ~51 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) Per RECIST 1.1 | DOR was assessed by BICR using RECIST 1.1. For participants who experience a response of CR or PR, DOR is defined as the time from the earliest date of qualifying response until earliest date of PD or death from any cause, whichever comes first. The DOR presented was analyzed using the product-limit (Kaplan-Meier) method for censored data. | All randomized participants that had a response | Posted | Median | 95% Confidence Interval | Months | Up to ~51 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score | The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are each scored on a 7-point scale (1=Very poor to 7=Excellent). The two raw scores were averaged into a combined score, then normalized using linear transformation so each participant's score ranged from 0 to 100 (0=Worst overall health/quality of life and 100=Best overall health/quality of life). The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score is presented. | All randomized participants who had at least 1 patient reported outcome (PRO) assessment available and had received at least 1 dose of study intervention | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and Week 18 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to True Deterioration (TTD) in the EORTC Questionnaire Composite Endpoint of Cough, Chest Pain or Dyspnea | TTD is the time from baseline to first onset of 10 points or more deterioration from baseline with confirmation by the subsequent visit of 10 points or more deterioration from baseline in the composite endpoint of cough [EORTC QLQ-Lung Cancer Module 13 (LC13) Item 1; How much did you cough?], chest pain [EORTC QLQ-LC13 Item 10; Have you had pain in your chest?], or dyspnea [EORTC QLQ-C30 Item 8; Were you short of breath?]. Individual responses are given on a 4-point scale (1=Not at all; 4=Very much), with a lower score indicating a better outcome. The TTD was analyzed using the product-limit (Kaplan-Meier) method for censored data. The time to true deterioration in the composite endpoint of cough, chest pain or dyspnea is presented. | All randomized participants who had at least 1 PRO assessment available and had received at least 1 dose of study intervention | Posted | Median | 95% Confidence Interval | Months | Baseline and up to ~51 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced an Adverse Event (AE) | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The percentage of participants who experienced an AE is presented. | All randomized participants who received at least 1 dose of study intervention | Posted | Number | Percentage of Participants | Up to ~44 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Discontinued Study Treatment Due to AEs | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The percentage of participants who discontinued study treatment due to an adverse event is presented. | All randomized participants who received at least 1 dose of study intervention | Posted | Number | Percentage of Participants | Up to ~41 months |
|
Death and Adverse Events up to ~59 months.
Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" & "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
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 | Pembro + Pemetrexed + Chemo | Participants received pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W with no restrictions on the number of cycles PLUS platinum chemotherapy (chemo) (either carboplatin Area Under the Curve [AUC] 5 via IV infusion Q3W for 4 cycles [Cycles 1-4] or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles [Cycles 1-4]). | 219 | 245 | 86 | 245 | 233 | 245 |
| EG001 | Placebo + Pemetrexed + Chemo | Participants received normal saline solution via IV infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W with no restrictions on the number of cycles PLUS platinum chemotherapy (chemo)(either carboplatin AUC 5 via IV infusion Q3W for 4 cycles [Cycles 1-4] or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles [Cycles 1-4]). Eligible participants who had BICR-verified progressive disease were eligible to switch over to pembrolizumab monotherapy 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles. | 186 | 247 | 70 | 246 | 225 | 246 |
| EG002 | Placebo + Pemetrexed + Chemo Switched Over to Pembro Monotherapy | Participants who received placebo + pemetrexed + chemo per their randomized treatment assignment and had BICR-verified progressive disease were eligible to receive pembrolizumab monotherapy 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles. | 44 | 50 | 8 | 50 | 31 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Macular hole | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Mesenteric artery thrombosis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rectal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Systemic infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fulminant type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Stroke in evolution | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vocal cord paresis | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Immune-mediated nephritis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lichenoid keratosis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
|
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp and Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Aug 20, 2024 |
| Prot_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 |
|---|---|
| C582435 | pembrolizumab |
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D000077330 | Saline Solution |
| 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 |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Non-East Asia |
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| EU |
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| Non-EU |
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| US |
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| Non-US |
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| TPS <50% |
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| TPS ≥1% AND ≤49% |
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| TPS <1% |
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| Not evaluable |
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| Treated with first line Osimertinib |
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| Treated with second line Osimertinib |
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| Other |
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| OG001 | Placebo + Pemetrexed + Chemo | Participants received normal saline solution via IV infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W with no restrictions on the number of cycles PLUS platinum chemotherapy (chemo)(either carboplatin AUC 5 via IV infusion Q3W for 4 cycles [Cycles 1-4] or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles [Cycles 1-4]). Eligible participants who had BICR-verified progressive disease were eligible to switch over to pembrolizumab monotherapy 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles. |
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| Placebo + Pemetrexed + Chemo |
Participants received normal saline solution via IV infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W with no restrictions on the number of cycles PLUS platinum chemotherapy (chemo)(either carboplatin AUC 5 via IV infusion Q3W for 4 cycles [Cycles 1-4] or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles [Cycles 1-4]). Eligible participants who had BICR-verified progressive disease were eligible to switch over to pembrolizumab monotherapy 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles. |
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