Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| J2G-MC-JZJC | Other Identifier | Eli Lilly and Company | |
| 2019-001979-36 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Loxo Oncology, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
The reason for this study is to see if the study drug selpercatinib compared to a standard treatment is effective and safe in participants with rearranged during transfection (RET) fusion-positive non-squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selpercatinib - Treatment A (TRT A) | Experimental | 160 milligram (mg) Selpercatinib administered orally twice daily (BID) continuously in 21-day cycles. |
|
| Pemetrexed and Platinum with or without Pembrolizumab - (TRT B) | Active Comparator | Pemetrexed 500 milligrams per meter squared (mg/m2) administered intravenously (IV) on Day 1, every 3 weeks (Q3W), plus investigator's choice of carboplatin area under the concentration versus time curve 5 (AUC 5 [maximum dose of 750 mg] IV), or cisplatin (75 mg/m2 cisplatin IV) on Day 1 Q3W for 4 cycles, plus investigator's choice with or without 200 mg pembrolizumab IV on Day 1 Q3W up to 35 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selpercatinib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (With Pembrolizumab) | PFS is defined as the time from randomization until the occurrence of documented disease progression by the BICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, or death from any cause in the absence of BICR-documented progressive disease. | Baseline to Progressive Disease or Death from Any Cause Up to 31 Months |
| PFS by BICR (With or Without Pembrolizumab) | PFS is defined as the time from randomization until the occurrence of documented disease progression by the BICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, or death from any cause in the absence of BICR-documented progressive disease. | Baseline to Progressive Disease or Death from Any Cause Up to 31 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participant With Disease Control Rate (DCR) by BICR (With Pembrolizumab) | DCR by BICR (with Pembrolizumab) is defined as the number of participants who achieve a BOR of complete response (CR), partial response (PR), or stable disease (SD) lasting 16 or more weeks divided by the total number of participants randomized to each treatment arm. | Baseline to Progressive Disease or Death from Any Cause Up to 31 Months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for Participants Receiving Pembrolizumab:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Oncología e Investigación de Buenos Aires | Berazategui | Buenos Aires | B1884BBF | Argentina | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41996652 | Derived | Duke ES, Bradford D, Sinha AK, Li X, Mishra-Kalyani PS, de Claro RA, Larkins E, Drezner N. Selpercatinib and the Crossover Conundrum: Potential Impact of Postprogression Therapies on Overall Survival. J Clin Oncol. 2026 May 20;44(15):1457-1464. doi: 10.1200/JCO-25-02375. Epub 2026 Apr 17. | |
| 38828957 | Derived |
| Label | URL |
|---|---|
| A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer | View source |
Not provided
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
If a participant has a recorded death on study, or is alive and being followed but off treatment, then the participant can be considered to be study completer.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Selpercatinib (TRT A) | 160 milligram (mg) Selpercatinib administered orally, twice daily (BID) continuously in 21-day cycles. |
| FG001 | Pemetrexed and Platinum With or Without Pembrolizumab (TRT B) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 15, 2023 | Mar 19, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Carboplatin | Drug | Administered IV |
|
| Cisplatin | Drug | Administered IV |
|
| Pemetrexed | Drug | Administered IV |
|
| Pembrolizumab | Drug | Administered IV |
|
| Percentage of Participant With DCR by BICR (With or Without Pembrolizumab) | DCR by BICR (with or without Pembrolizumab) is defined as the number of participants who achieve a BOR of CR, PR, or SD lasting 16 or more weeks divided by the total number of participants randomized to each treatment arm. | Baseline to Progressive Disease or Death from Any Cause Up to 31 Months |
| PFS2 (With Pembrolizumab) | PFS2 is defined as the time from randomization to disease progression on the next line of treatment or death from any cause in the absence of observed disease progression. | Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months |
| PFS2 (With or Without Pembrolizumab) | PFS2 is defined as the time from randomization to disease progression on the next line of treatment or death from any cause in the absence of observed disease progression. | Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months |
| Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) by BICR (With Pembrolizumab) | ORR is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of participants randomized to each treatment arm. | Baseline through Disease Progression or Death Up to 31 Months |
| ORR: Percentage of Participants With CR or PR by BICR (With or Without Pembrolizumab) | ORR is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of participants randomized to each treatment arm. | Baseline through Disease Progression or Death Up to 31 Months |
| Duration of Response (DoR) by BICR (With Pembrolizumab) | DoR was defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) were first met until the first date that disease was recurrent or documented disease progression was observed, or the date of death from any cause in the absence of documented disease progression or recurrence. The DOR according to both BICR and investigator-assessed BOR was evaluated per RECIST 1.1 criteria. | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause Up to 31 Months |
| DOR by BICR (With or Without Pembrolizumab) | DoR was defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) were first met until the first date that disease was recurrent or documented disease progression was observed, or the date of death from any cause in the absence of documented disease progression or recurrence. The DOR according to both BICR and investigator-assessed BOR was evaluated per RECIST 1.1 criteria. | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause Up to 31 Months |
| Overall Survival (OS) (With Pembrolizumab) | Overall survival was defined as the time from randomization until death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data was censored on the last date the participant is known to be alive. | Baseline to Date of Death from Any Cause Up to 38 Months |
| OS (With or Without Pembrolizumab) | Overall survival was defined as the time from randomization until death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. | Baseline to Date of Death from Any Cause Up to 38 Months |
| Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 by BICR (With Pembrolizumab) | Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with Pembrolizumab) | Baseline through Central Nervous System (CNS) Progression or Death up to 31 Months |
| Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per RECIST 1.1 by BICR (With or Without Pembrolizumab) | Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with or without Pembrolizumab) | Baseline through CNS Progression or Death Up to 31 Months |
| Median Intracranial DOR Per RECIST 1.1 by BICR (With Pembrolizumab) | Intracranial DOR per RECIST 1.1 by BICR (with Pembrolizumab) | Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months |
| Median Intracranial DOR Per RECIST 1.1 by BICR (With or Without Pembrolizumab) | Median Intracranial DOR per RECIST 1.1 by BICR (with or without Pembrolizumab) | Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months |
| Time to Deterioration of Pulmonary Symptoms (With Pembrolizumab) | Time to Deterioration of Pulmonary Symptoms Measured by the NSCLC-Symptom Assessment Questionnaire (SAQ) (with Pembrolizumab) | Baseline to Deterioration of Pulmonary Symptoms Up to 31 Months |
| Time to Deterioration of Pulmonary Symptoms (With or Without Pembrolizumab) | Time to Deterioration of Pulmonary Symptoms Measured by the NSCLC-SAQ (with or without Pembrolizumab) | Baseline to Deterioration of Pulmonary Symptoms Up to 31 Months |
| The Concordance of the Local Lab and the Central Lab RET Results: Percentage of Participants With RET-Positive Specimens as Called by the Central Lab, Which is Also RET-Positive as Called by a Local Lab (Positive Percent Agreement) | The Concordance of the Local Lab and the Central Lab RET Results: Percentage of Participants with RET-Positive Specimens as Called by the Central Lab, which is also RET-Positive as Called by a Local Lab (Positive Percent Agreement) | Baseline |
| Median Time to CNS Progression Per RECIST 1.1 by BICR (With Pembrolizumab) | Time to CNS Progression per RECIST 1.1 by BICR (with Pembrolizumab) | Baseline through CNS Progression or Death Up to 31 Months |
| Median Time to CNS Progression Per RECIST 1.1 by BICR (With or Without Pembrolizumab) | Time to CNS Progression per RECIST 1.1 by BICR (with or without Pembrolizumab) | Baseline through CNS Progression or Death Up to 31 Months |
| Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) by BICR (With Pembrolizumab) | Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RANO-BM by BICR (with Pembrolizumab) | Baseline through CNS Progression or Death Up to 31 Months |
| Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per RANO-BM by BICR (With or Without Pembrolizumab) | Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RANO-BM by BICR (with or without Pembrolizumab) | Baseline through CNS Progression or Death Up to 31 Months |
| Intracranial DOR Per RANO-BM by BICR (With Pembrolizumab) | Intracranial DOR per RANO-BM by BICR (with Pembrolizumab) | Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months |
| Intracranial DOR Per RANO-BM by BICR (With or Without Pembrolizumab) | Intracranial DOR per RANO-BM by BICR (with or without Pembrolizumab) | Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months |
| Fundacion CENIT para la Investigacion en Neurociencias |
| Caba |
| Buenos Aires |
| 1125 |
| Argentina |
| Clinica Viedma | Viedma | Río Negro Province | R8500ACE | Argentina |
| Alexander Fleming | Ciudad de Buenos Aires | C1426ANZ | Argentina |
| Clínica El Castaño | San Juan | 5400 | Argentina |
| Chris O'Brien Lifehouse | Camperdown | New South Wales | 2050 | Australia |
| Calvary Mater Newcastle | Waratah | New South Wales | 2298 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Monash Health | Clayton | Victoria | 3168 | Australia |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| St Vincent's Hospital | Melbourne | Victoria | 3065 | Australia |
| Peninsula Oncology Centre | Frankston | 3199 | Australia |
| UZ Brussel | Brussels | Bruxelles-Capitale, Région de | 1090 | Belgium |
| AZ Nikolaas | Sint-Niklaas | Oost-Vlaanderen | B-9100 | Belgium |
| UZ Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
| AZ Delta | Roeselare | West Flanders | 8800 | Belgium |
| UZ Gent Hospital | Ghent | 9000 | Belgium |
| AZ Sint-Maarten, Campus Leopoldstraat 2 | Mechelen | 2800 | Belgium |
| CHU UCL Namur/Site Sainte Elisabeth | Namur | 5000 | Belgium |
| Hospital Sírio Libanês | São Paulo | Brazil | 01308-060 | Brazil |
| Núcleo de Oncologia da Bahia | Salvador | Estado de Bahia | 40170-070 | Brazil |
| Hospital de Cancer de Londrina | Londrina | Paraná | 86015-520 | Brazil |
| Grupo COI - Clínicas Oncológicas Integradas | Rio de Janeiro | Rio de Janeiro | 22775-001 | Brazil |
| Hospital São Lucas da PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Fundação Pio XII - Hospital de Câncer de Barretos | Barretos | São Paulo | 14784-400 | Brazil |
| Instituto D'Or de Pesquisa e Ensino (IDOR) | São Paulo | São Paulo | 04543-000 | Brazil |
| Instituto Nacional de Câncer - INCA | Rio de Janeiro | 20231-050 | Brazil |
| Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA | Rio de Janeiro | 22250-905 | Brazil |
| Icesp - Instituto Do Câncer Do Estado de São Paulo | São Paulo | 01246000 | Brazil |
| Hospital Sírio Libanês | São Paulo | 01308-060 | Brazil |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Beijing Cancer hospital | Beijing | Beijing Municipality | 100142 | China |
| First affiliated Hospital of Sun Yat-Sen University | Guangzhou | Guangdong | 510080 | China |
| The First Affiated Hospital Of Guangzhou Medical Collage | Guangzhou | Guangzhou | 510120 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150081 | China |
| Wuhan Union Hospital | Wuhan | Hubei | 430022 | China |
| Hunan Provincial People's Hospital | Changsha | Hunan | 410005 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| Changzhou No.2 People's Hospital | Changzhou | Jiangsu | China |
| Jilin Cancer Hospital | Changchun | Jilin | China |
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| Xinjiang Medical University Cancer Hospital - Urumqi | Ürümqi | Xinjiang | 830000 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China |
| First Affiliated Hosp of College of Med, Zhejiang University | Hangzhou | 310003 | China |
| Shanghai Chest Hospital | Shanghai | 200030 | China |
| Fakultni nemocnice Olomouc | Olomouc | 779 00 | Czechia |
| Nemocnice AGEL Ostrava - Vitkovice a.s. | Ostrava - Vitkovice | 70384 | Czechia |
| Fakultni nemocnice Bulovka | Prague | 180 81 | Czechia |
| Centre Leon Berard | Lyon | Auvergne-Rhône-Alpes | 69373 | France |
| Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone | Marseille | Bouches-du-Rhône | 13385 | France |
| Institut Régional du Cancer Montpellier | Montpellier | Hérault | 34298 | France |
| Chu Grenoble Alpes | La Tronche | Isère | 38700 | France |
| Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne | Clermont-Ferrand | Puy-de-Dôme | 63011 | France |
| Hopitaux Universitaires Paris Centre-Hopital Cochin | Paris | 75014 | France |
| Thoraxklinik-Heidelberg gGmbH | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| Asklepios Fachkliniken München-Gauting | Gauting | Bavaria | 82131 | Germany |
| Klinikverbund Kempten-Oberallgäu | Immenstadt im Allgäu | Bavaria | 87509 | Germany |
| Franziskus-Hospital Harderberg | Georgsmarienhütte | Lower Saxony | 49124 | Germany |
| Universitätsmedizin Göttingen | Göttingen | Lower Saxony | 37075 | Germany |
| University Hospital of Cologne | Cologne | North Rhine-Westphalia | 50937 | Germany |
| LungenClinic Grosshansdorf | Großhansdorf | Schleswig-Holstein | 22927 | Germany |
| Charite Universitätsmedizin Berlin Campus Benjamin Franklin | Berlin | 12203 | Germany |
| Sotiria Thoracic Diseases Hospital of Athens | Athens | Attikí | 115 27 | Greece |
| University General Hospital of Heraklion | Heraklion | Krítí | 711 10 | Greece |
| European Interbalkan Medical Center | Thessaloniki | Thessaloníki | 570 01 | Greece |
| G. Papanikolaou General Hospital | Thessaloniki | Thessaloníki | 570 10 | Greece |
| Hong Kong United Oncology Centre | Jordan | Kowloon | 999077 | Hong Kong |
| Prince of Wales Hospital | Shatin | 852 | Hong Kong |
| Soroka Medical Center | Beersheba | 8400000 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Hadassah Medical Center | Jerusalem | 9112001 | Israel |
| Sheba Medical Center | Ramat Gan | 5262100 | Israel |
| Rambam Health Care Campus | Haifa | Ḥeifā | 3109601 | Israel |
| Istituto Nazionale Tumori IRCCS Fondazione Pascale | Naples | Campania | 80131 | Italy |
| Ospedale Santa Maria delle Croci | Ravenna | Emilia-Romagna | 48121 | Italy |
| Cro-Irccs | Aviano | Friuli Venezia Giulia | 33081 | Italy |
| Azienda Ospedaliera San Camillo Forlanini | Rome | Lazio | 00152 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli | Rome | Lazio | 00168 | Italy |
| Ospedale San Gerardo-ASST Monza | Monza | Lombardy | 20900 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Milano | 20162 | Italy |
| Humanitas | Rozzano | Milano | 20089 | Italy |
| Azienda Sanitaria Ospedaliera S Luigi Gonzaga | Orbassano | Torino | 10043 | Italy |
| Azienda Ospedaliera San Giuseppe Moscati | Avellino | 83100 | Italy |
| IRCCS - AOU di Bologna | Bologna | 40138 | Italy |
| Azienda Ospedaliera Universitaria Pisana | Pisa | 56126 | Italy |
| Istituto Nazionale Tumori Regina Elena | Roma | 00144 | Italy |
| National Cancer Center Hospital East | Kashiwa | Chiba | 277-8577 | Japan |
| National Hospital Organization Hokkaido Cancer Center | Sapporo | Hokkaido | 003-0804 | Japan |
| Kanazawa University Hospital | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Kanagawa cancer center | Yokohama | Kanagawa | 241-8515 | Japan |
| Kindai University Hospital- Osakasayama Campus | Osaka Sayama-shi | Osaka | 589 8511 | Japan |
| Tominaga Hospital | Nakatogari | Shizuoka | 411-8777 | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 104-0045 | Japan |
| Japanese Foundation for Cancer Research | Koto | Tokyo | 135-8550 | Japan |
| Tottori University Hospital | Yonago | Tottori | 683-8504 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Osaka International Cancer Institute | Osaka | 541-8567 | Japan |
| Health Pharma Professional Research S.A. de C.V: | Mexico City | Federal District | 03100 | Mexico |
| Actualidad Basada en la Investigación del Cáncer | Guadalajara | Jalisco | 44680 | Mexico |
| Oncologico Potosino, S.C. | San Luis Potosí City | 78209 | Mexico |
| Ziekenhuis St. Jansdal | Harderwijk | Gelderland | 3844 DG | Netherlands |
| Jeroen Bosch Hospital | 's-Hertogenbosch | North Brabant | 5223 GZ | Netherlands |
| Erasmus Medisch Centrum | Rotterdam | South Holland | 3015 CE | Netherlands |
| Amsterdam UMC, locatie VUmc | Amsterdam | 1081 HV | Netherlands |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-952 | Poland |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy | Warsaw | 02-781 | Poland |
| Gral Medical Diagnostic Center | Bucharest | Bucharest | 031422 | Romania |
| Institutul Oncologic | Bucharest | Bucharest | 22328 | Romania |
| Constanta County Emergency Clinical Hospital Sf.Ap.Andrei | Constanța | Constanța County | 900591 | Romania |
| Cabinet Medical Oncomed | Timișoara | Timiș County | 300239 | Romania |
| Spitalul Universitar de Urgență București | Bucharest | 050098 | Romania |
| Institutul Oncologic | Cluj-Napoca | 400015 | Romania |
| Spitalul Județean Sfântul Ioan cel Nou Suceava | Suceava | 720237 | Romania |
| GBUZ Republican Clinical Oncological Dispensary | Ufa | Baškortostan, Respublika | 450054 | Russia |
| Kaluga Regional Clinical Oncology Center | Kaluga | Kalužskaja Oblast | 248007 | Russia |
| Murmansk Regional Clinical Hospital P.A. Bayandina | Murmansk | Murmansk Oblast | 183047 | Russia |
| Samara Regional Clinical Oncology Center | Samara | Samara Oblast | 443031 | Russia |
| Saint-Petersburg Scientific-Practical Center of Specialized Kinds of Medical Care (oncological) named afte -T | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| Scientific research institution of oncology named after N.N. Petrov | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| Arkhangelsk Clinical Oncological Dispensary | Arkhangelsk | 163045 | Russia |
| Republican Clinical Oncology Dispensary | Kazan' | 420029 | Russia |
| First Moscow State Medical University I.M. Sechenov | Moscow | 119991 | Russia |
| Hadassah Medical | Moscow | 121205 | Russia |
| Tan Tock Seng Hospital | Singapore | 308433 | Singapore |
| National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Gachon University Gil Medical Center | Incheon | Korea | 21565 | South Korea |
| Asan Medical Center | Seoul | Korea | 05505 | South Korea |
| Gyeongsang National University Hospital | Jinju | Kyǒngsangnam-do | 52727 | South Korea |
| Seoul National University Hospital | Seoul | Seoul, Korea | 03080 | South Korea |
| Boramae Medical Center | Dongjak-gu | Seoul-teukbyeolsi [Seoul] | 07061 | South Korea |
| Konyang University Hospital | Daejeon | 35365 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital Fundacion Son Llatzer | Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Institut Català d'Oncologia (ICO) - Badalona | Badalona | Barcelona [Barcelona] | 08916 | Spain |
| CHUS - Hospital Clinico Universitario | Santiago de Compostela | Galicia [Galicia] | 15706 | Spain |
| Hospital Insular de Gran Canaria | Las Palmas de Gran Canaria | Las Palmas | 35016 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Clinica Universitaria De Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Parc de Salut Mar - Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Universitari Dexeus | Barcelona | 08028 | Spain |
| Instituto Catalan de Oncologia - Hospital Duran i Reynals | Barcelona | 08908 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 8041 | Spain |
| Complejo Hospitalario de Jaén | Jaén | 23007 | Spain |
| Clinica Universidad de Navarra | Madrid | 28027 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Regional Universitario | Málaga | 29011 | Spain |
| Complejo Hospitalario de Navarra | Pamplona | 31009 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | 41013 | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Changhua Christian Hospital | Changhua County | Changhua | 50006 | Taiwan |
| Buddhist Dalin Tzu Chi General Hospital | Dalin Town | Chiayi | 622 | Taiwan |
| Chang Gung Memorial Hospital - Linkou | Guei Shan Township | Taoyuan County | 333 | Taiwan |
| E-Da hospital | Kaohsiung City | 82445 | Taiwan |
| Chang Gung Memorial Hospital at Kaohsiung | Kaohsiung City | 83301 | Taiwan |
| Tri-Service General Hospital | Neihu Taipei | 114 | Taiwan |
| Taipei Medical University Shuang Ho Hospital | New Taipei City | 235 | Taiwan |
| Chung Shan Medical University Hospital | Taichung | 402 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 407 | Taiwan |
| National Cheng-Kung Uni. Hosp. | Tainan | 704 | Taiwan |
| Chi Mei Hospital - Liouying Branch | Tainan | 73657 | Taiwan |
| National Taiwan University Hospital | Taipei | 10048 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Ege Universitesi Hastanesi | Bornova | İzmir | 35100 | Turkey (Türkiye) |
| Baskent University Dr. Turgut Noyan Research and Training Center | Adana | 1250 | Turkey (Türkiye) |
| Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital | Ankara | 6200 | Turkey (Türkiye) |
| Hacettepe University Faculty of Medicine | Ankara | 6230 | Turkey (Türkiye) |
| Memorial Antalya Hastanesi | Antalya | 7090 | Turkey (Türkiye) |
| Dicle Üniversitesi | Diyarbakır | 21100 | Turkey (Türkiye) |
| Trakya University | Edirne | 22030 | Turkey (Türkiye) |
| Istanbul Medeniyet University | Istanbul | 34722 | Turkey (Türkiye) |
| zmir Katip Çelebi Üniversitesi Atatürk Eitim Ve Aratrma Hastanesi | Izmir | 35360 | Turkey (Türkiye) |
| Izmir Medical Park Hospital | Izmir | 9035575 | Turkey (Türkiye) |
| Inonu Universitesi Turgut Ozal Tıp Merkezi | Malatya | 44280 | Turkey (Türkiye) |
| Acıbadem Maslak Hastanesi | Sariyer | 34457 | Turkey (Türkiye) |
| Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council, "Dnipro State Medical University" | Dnipro | Dnipropetrovsk Oblast | 49102 | Ukraine |
| CNPE "Regional Center of Oncology" | Kharkiv | Kharkiv Oblast | 61070 | Ukraine |
| Odessa Regional Oncology Center | Odesa | Odesa Oblast | 65055 | Ukraine |
| Sumy regional clinical oncological dispensary | Sumy | Sumska Oblast | 40022 | Ukraine |
| Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" | Vinnytsia | Vinnytsia Oblast | 21029 | Ukraine |
| Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council | Lutsk | Volyn Oblast | 43018 | Ukraine |
| "Oncolife" LLC | Zaporizhya | Zaporizhzhia Oblast | 69059 | Ukraine |
| Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" | Chernivtsi | 58013 | Ukraine |
| Medical Center "Mriya Med-Service", LLC | Kryvyi Rig | 50000 | Ukraine |
| Municipal non-profit enterprise "Kyiv City Clinical Oncology Center" of executive body of Kyiv City Counci -T | Kyiv | 03115 | Ukraine |
| Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council | Odesa | 65025 | Ukraine |
| City Hospital, Nottingham University Hospitals | Nottingham | Nottinghamshire | NG5 1PB | United Kingdom |
| Perol M, Solomon BJ, Goto K, Park K, Nadal E, Bria E, Martin C, Bar J, Williams JN, Puri T, Li J, Uh MK, Lin BK, Zhou C. CNS Protective Effect of Selpercatinib in First-Line RET Fusion-Positive Advanced Non-Small Cell Lung Cancer. J Clin Oncol. 2024 Jul 20;42(21):2500-2505. doi: 10.1200/JCO.24.00724. Epub 2024 Jun 3. |
| 37870973 | Derived | Zhou C, Solomon B, Loong HH, Park K, Perol M, Arriola E, Novello S, Han B, Zhou J, Ardizzoni A, Mak MP, Santini FC, Elamin YY, Drilon A, Wolf J, Payakachat N, Uh MK, Rajakumar D, Han H, Puri T, Soldatenkova V, Lin AB, Lin BK, Goto K; LIBRETTO-431 Trial Investigators. First-Line Selpercatinib or Chemotherapy and Pembrolizumab in RET Fusion-Positive NSCLC. N Engl J Med. 2023 Nov 16;389(20):1839-1850. doi: 10.1056/NEJMoa2309457. Epub 2023 Oct 21. |
| 35378489 | Derived | Claerhout S, Lehnert S, Vander Borght S, Spans L, Dooms C, Wauters E, Vansteenkiste J, Weynand B, Deraedt K, Bourgain C, Vanden Bempt I. Targeted RNA sequencing for upfront analysis of actionable driver alterations in non-small cell lung cancer. Lung Cancer. 2022 Apr;166:242-249. doi: 10.1016/j.lungcan.2022.02.013. Epub 2022 Mar 1. |
| 33150799 | Derived | Solomon BJ, Zhou CC, Drilon A, Park K, Wolf J, Elamin Y, Davis HM, Soldatenkova V, Sashegyi A, Lin AB, Lin BK, F Loong HH, Novello S, Arriola E, Perol M, Goto K, Santini FC. Phase III study of selpercatinib versus chemotherapy +/- pembrolizumab in untreated RET positive non-small-cell lung cancer. Future Oncol. 2021 Mar;17(7):763-773. doi: 10.2217/fon-2020-0935. Epub 2020 Nov 5. |
Pemetrexed 500 milligrams per meter squared (mg/m2) administered intravenously (IV) on Day 1, every 3 weeks (Q3W), plus investigator's choice of carboplatin area under the concentration versus time curve 5 (AUC 5 [maximum dose 750 mg]) IV, or cisplatin 75mg/m2 IV on Day 1 Q3W for 4 cycles, plus investigator's choice with or without 200 mg pembrolizumab IV on Day 1 Q3W up to 35 cycles.
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent to Treat Population (ITT): All randomized participants, even if a participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Selpercatinib (TRT A) | 160 mg Selpercatinib administered orally BID continuously in 21-day cycles. |
| BG001 | Pemetrexed and Platinum With or Without Pembrolizumab (TRT B) | Pemetrexed 500 mg/m2, IV on Day 1 Q3W plus investigator's choice of carboplatin (AUC 5 [maximum dose 750 mg] IV) or cisplatin 75mg/m2, IV on Day 1 Q3W for 4 cycles, plus investigator's choice with or without 200 mg pembrolizumab IV on Day 1 Q3W 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 | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| 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) by Blinded Independent Central Review (BICR) (With Pembrolizumab) | PFS is defined as the time from randomization until the occurrence of documented disease progression by the BICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, or death from any cause in the absence of BICR-documented progressive disease. | Intent to Treat (ITT) Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. Participants censored: TRT A: 80, TRT B: 34. | Posted | Median | 95% Confidence Interval | Months | Baseline to Progressive Disease or Death from Any Cause Up to 31 Months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | PFS by BICR (With or Without Pembrolizumab) | PFS is defined as the time from randomization until the occurrence of documented disease progression by the BICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, or death from any cause in the absence of BICR-documented progressive disease. | ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Participants censored: TRT A: 98, TRT B:45. | Posted | Median | 95% Confidence Interval | Months | Baseline to Progressive Disease or Death from Any Cause Up to 31 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participant With Disease Control Rate (DCR) by BICR (With Pembrolizumab) | DCR by BICR (with Pembrolizumab) is defined as the number of participants who achieve a BOR of complete response (CR), partial response (PR), or stable disease (SD) lasting 16 or more weeks divided by the total number of participants randomized to each treatment arm. | ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline to Progressive Disease or Death from Any Cause Up to 31 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participant With DCR by BICR (With or Without Pembrolizumab) | DCR by BICR (with or without Pembrolizumab) is defined as the number of participants who achieve a BOR of CR, PR, or SD lasting 16 or more weeks divided by the total number of participants randomized to each treatment arm. | ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline to Progressive Disease or Death from Any Cause Up to 31 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS2 (With Pembrolizumab) | PFS2 is defined as the time from randomization to disease progression on the next line of treatment or death from any cause in the absence of observed disease progression. | ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. Participants censored: TRT A: 103; TRT B: 62 | Posted | Median | 95% Confidence Interval | Months | Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PFS2 (With or Without Pembrolizumab) | PFS2 is defined as the time from randomization to disease progression on the next line of treatment or death from any cause in the absence of observed disease progression. | ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Participants censored: TRT A: 126; TRT B: 77 | Posted | Median | 95% Confidence Interval | Months | Baseline to Second Disease Progression or Death from Any Cause Up to 38 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) by BICR (With Pembrolizumab) | ORR is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of participants randomized to each treatment arm. | ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline through Disease Progression or Death Up to 31 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ORR: Percentage of Participants With CR or PR by BICR (With or Without Pembrolizumab) | ORR is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of participants randomized to each treatment arm. | ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline through Disease Progression or Death Up to 31 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) by BICR (With Pembrolizumab) | DoR was defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) were first met until the first date that disease was recurrent or documented disease progression was observed, or the date of death from any cause in the absence of documented disease progression or recurrence. The DOR according to both BICR and investigator-assessed BOR was evaluated per RECIST 1.1 criteria. | ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. Participants censored: TRT A:74; TRT B: 25. | Posted | Median | 95% Confidence Interval | Months | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause Up to 31 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DOR by BICR (With or Without Pembrolizumab) | DoR was defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) were first met until the first date that disease was recurrent or documented disease progression was observed, or the date of death from any cause in the absence of documented disease progression or recurrence. The DOR according to both BICR and investigator-assessed BOR was evaluated per RECIST 1.1 criteria. | ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Participants censored: TRT A: 90; TRT B: 33. | Posted | Median | 95% Confidence Interval | Months | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause Up to 31 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) (With Pembrolizumab) | Overall survival was defined as the time from randomization until death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data was censored on the last date the participant is known to be alive. | ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. Participants censored: TRT A: 104; TRT B: 68. | Posted | Median | 95% Confidence Interval | Months | Baseline to Date of Death from Any Cause Up to 38 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | OS (With or Without Pembrolizumab) | Overall survival was defined as the time from randomization until death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. | ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Participants censored: TRT A: 127; TRT B: 84. | Posted | Median | 95% Confidence Interval | Months | Baseline to Date of Death from Any Cause Up to 38 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 by BICR (With Pembrolizumab) | Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with Pembrolizumab) | CNS Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment who had baseline CNS assessment and who had CNS metastasis at baseline. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline through Central Nervous System (CNS) Progression or Death up to 31 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per RECIST 1.1 by BICR (With or Without Pembrolizumab) | Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RECIST 1.1 by BICR (with or without Pembrolizumab) | CNS Overall: All participants included in the ITT population who had baseline CNS assessment and who had CNS metastasis at baseline. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline through CNS Progression or Death Up to 31 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Intracranial DOR Per RECIST 1.1 by BICR (With Pembrolizumab) | Intracranial DOR per RECIST 1.1 by BICR (with Pembrolizumab) | CNS Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment who had baseline CNS assessment and who had CNS metastasis at baseline. Participants censored: TRT A: 13; TRT B: 9. | Posted | Median | 95% Confidence Interval | Months | Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Intracranial DOR Per RECIST 1.1 by BICR (With or Without Pembrolizumab) | Median Intracranial DOR per RECIST 1.1 by BICR (with or without Pembrolizumab) | CNS Overall: All participants included in the ITT population who had baseline CNS assessment and who had CNS metastasis at baseline. Participants censored: TRT A: 15; TRT B: 9. | Posted | Median | 95% Confidence Interval | Months | Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Deterioration of Pulmonary Symptoms (With Pembrolizumab) | Time to Deterioration of Pulmonary Symptoms Measured by the NSCLC-Symptom Assessment Questionnaire (SAQ) (with Pembrolizumab) | ITT Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment. Participants censored: TRT A: 99; TRT B: 47. | Posted | Median | 95% Confidence Interval | Months | Baseline to Deterioration of Pulmonary Symptoms Up to 31 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Deterioration of Pulmonary Symptoms (With or Without Pembrolizumab) | Time to Deterioration of Pulmonary Symptoms Measured by the NSCLC-SAQ (with or without Pembrolizumab) | ITT Population: All randomized participants, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. Participants censored: TRT A: 121; TRT B: 58. | Posted | Median | 95% Confidence Interval | Months | Baseline to Deterioration of Pulmonary Symptoms Up to 31 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Concordance of the Local Lab and the Central Lab RET Results: Percentage of Participants With RET-Positive Specimens as Called by the Central Lab, Which is Also RET-Positive as Called by a Local Lab (Positive Percent Agreement) | The Concordance of the Local Lab and the Central Lab RET Results: Percentage of Participants with RET-Positive Specimens as Called by the Central Lab, which is also RET-Positive as Called by a Local Lab (Positive Percent Agreement) | Not Posted | Jun 2026 | Baseline | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Time to CNS Progression Per RECIST 1.1 by BICR (With Pembrolizumab) | Time to CNS Progression per RECIST 1.1 by BICR (with Pembrolizumab) | CNS Pembrolizumab: Participants included in the ITT population who were stratified with the intent to receive pembrolizumab in the event of the control-arm assignment who had baseline CNS assessment and who had CNS metastasis at baseline. Number of participants censored: TRT A = 112; TRT B = 59. | Posted | Median | 95% Confidence Interval | Months | Baseline through CNS Progression or Death Up to 31 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Time to CNS Progression Per RECIST 1.1 by BICR (With or Without Pembrolizumab) | Time to CNS Progression per RECIST 1.1 by BICR (with or without Pembrolizumab) | CNS Overall: All participants included in the ITT population who had baseline CNS assessment and who had CNS metastasis at baseline. Participants censored: TRT A: 137; TRT B: = 73. | Posted | Median | 95% Confidence Interval | Months | Baseline through CNS Progression or Death Up to 31 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) by BICR (With Pembrolizumab) | Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RANO-BM by BICR (with Pembrolizumab) | Not Posted | Jun 2026 | Baseline through CNS Progression or Death Up to 31 Months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Intracranial ORR: Percentage of Participants With Intracranial CR or PR Per RANO-BM by BICR (With or Without Pembrolizumab) | Intracranial ORR: Percentage of Participants with Intracranial CR or PR per RANO-BM by BICR (with or without Pembrolizumab) | Not Posted | Jun 2026 | Baseline through CNS Progression or Death Up to 31 Months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Intracranial DOR Per RANO-BM by BICR (With Pembrolizumab) | Intracranial DOR per RANO-BM by BICR (with Pembrolizumab) | Not Posted | Jun 2026 | Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Intracranial DOR Per RANO-BM by BICR (With or Without Pembrolizumab) | Intracranial DOR per RANO-BM by BICR (with or without Pembrolizumab) | Not Posted | Jun 2026 | Date of Intracranial CR or PR to Date of CNS Progression or Death Due to Any Cause Up to 31 Months | Participants |
Baseline Up to 38 Months
Safety population is defined as all participants who received study drug regardless of strata and as pre-specified, adverse events were collected for the TRT B treatment arm as a whole. Analysis of safety data will be based on the actual treatment a participant received on the first study treatment administration regardless of which treatment they were randomized to receive ("as treated").
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 | Selpercatinib (TRT A) | 160 milligram (mg) Selpercatinib administered orally, twice daily (BID continuously in 21-day cycles. | 32 | 158 | 55 | 158 | 156 | 158 |
| EG001 | Carboplatin or Cisplatin+Pemetrexed+/-Pembrolizumab (TRT B) | Pemetrexed 500 milligrams per meter squared (mg/m2) administered intravenously (IV) on Day 1, every 3 weeks (Q3W), plus at the investigator's choice of carboplatin area under the concentration versus time curve 5 (AUC 5 [maximum dose 750 mg]) IV, or cisplatin 75mg/m2 IV on Day 1 Q3W for 4 cycles, plus investigator's choice with or without 200 mg pembrolizumab IV on Day 1 Q3W up to 35 cycles. | 17 | 98 | 23 | 98 | 97 | 98 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chest pain | 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 |
| |
| Sudden death | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Immune-mediated hepatic disorder | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Procedural haemorrhage | 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 |
| |
| Electrocardiogram t wave abnormal | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic enzyme 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 |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | 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 |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular 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 |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | 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 |
| |
| Lacrimation increased | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Stomatitis | 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 |
| |
| Face oedema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | 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 |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Electrocardiogram qt prolonged | 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 |
| |
| Weight increased | 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 |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoproteinaemia | 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 |
| |
| Myalgia | 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 |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue 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 |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-595-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2023 | Mar 19, 2024 | SAP_001.pdf |
Not provided
| 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 |
|---|---|
| C000656166 | selpercatinib |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D000068437 | Pemetrexed |
| C582435 | pembrolizumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| 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 |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Czechia |
|
| Russia |
|
| Greece |
|
| Netherlands |
|
| South Korea |
|
| China |
|
| Brazil |
|
| Poland |
|
| France |
|
| Argentina |
|
| Japan |
|
| Ukraine |
|
| Spain |
|
| Canada |
|
| Turkey |
|
| Belgium |
|
| Taiwan |
|
| Italy |
|
| Mexico |
|
| Israel |
|
| Australia |
|
| Germany |
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
| Participants |
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
|
|
| Participants |
|
|
|
|