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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002638-18 | EudraCT Number |
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The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily or 240 mg daily whose tumors are programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) < 1% and/or harbor a serine/threonine kinase 11 (STK11) co-mutation, in a subgroup of participants with PD-L1 < 1% and in a subgroup of participants with STK11 co-mutation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sotorasib: 960 mg Daily | Experimental | Participants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express < 1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment will be administered sotorasib 960 mg daily. Participants will be stratified by known presence of STK11 mutation. |
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| Sotorasib: 240 mg Daily | Experimental | Participants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express < 1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment will be administered sotorasib 240 mg daily. Participants will be stratified by known presence of STK11 mutation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotorasib | Drug | Oral tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (OR) | OR is defined as the total of Complete Response (CR) and Partial Response (PR). | Up to 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate | Up to 6 years | |
| Duration of Reponse (DOR) | Up to 6 years | |
| Time to Response (TTR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Oncology | Birmingham | Alabama | 35243 | United States | ||
| Arizona Oncology Associates Professional Corporation |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
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| Up to 6 years |
| Progression-free Survival (PFS) | Up to 6 years |
| Overall Survival (OS) | Up to 6 years |
| Number of Participants with a Treatment-emergent Adverse Event (TEAE) | Day 1 up to Month 13 |
| Number of Participants with a Treatment-related Adverse Event | Day 1 up to Month 13 |
| Number of Participants with a Clinically Significant Change from Baseline in Vital Signs | Baseline (Screening; up to 28 days pre-dose) up to Month 13 |
| Number of Participants with a Clinically Significant Change from Baseline in Electrocardiograms (ECGs) | Baseline (Screening; up to 28 days pre-dose) up to Month 13 |
| Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests | Baseline (Screening; up to 28 days pre-dose) up to Month 13 |
| Maximum Plasma Concentration (Cmax) of Sotorasib | Day 1 up to Month 3 |
| Time to Reach Maximum Plasma Concentration (tmax) of Sotorasib | Day 1 up to Month 3 |
| Area Under the Plasma Concentration-time Curve (AUC) of Sotorasib | Day 1 up to Month 3 |
| Tucson |
| Arizona |
| 85711 |
| United States |
| City of Hope at Long Beach Elm | Duarte | California | 91010 | United States |
| City of Hope National Medical Center | Duarte | California | 91010 | United States |
| Baptist MD Anderson Cancer Center | Jacksonville | Florida | 32207 | United States |
| Northwest Georgia Oncology Centers PC | Marietta | Georgia | 30060 | United States |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| Frederick Memorial Hospital | Frederick | Maryland | 21702 | United States |
| Englewood Hospital and Medical Center | Englewood | New Jersey | 07631 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| Laura and Isaac Perlmutter Cancer Center at New York University Langone | New York | New York | 10016 | United States |
| Northport Veterans Affairs Medical Center | Northport | New York | 11768 | United States |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | United States |
| James J Peters VA Medical Center | The Bronx | New York | 10468 | United States |
| Duke University Medical Center, Morris Cancer Clinic | Durham | North Carolina | 27710 | United States |
| Allegheny Health Network Cancer Institute at Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh Medical Center Cancer Pavillion | Pittsburgh | Pennsylvania | 15232 | United States |
| Medical University of South Carolina, Hollings Cancer Center | Charleston | South Carolina | 29425 | United States |
| Texas Oncology - Medical City Dallas | Dallas | Texas | 75230-2510 | United States |
| Texas Oncology - Plano East | Dallas | Texas | 75230-2510 | United States |
| Texas Oncology-Dallas Presbyterian Hospital | Dallas | Texas | 75231 | United States |
| Texas Oncology - Flower Mound | Dallas | Texas | 75234 | United States |
| Texas Oncology - Baylor | Dallas | Texas | 75246 | United States |
| Texas Oncology-Denton | Denton | Texas | 76201 | United States |
| Oncology Consultants PA | Houston | Texas | 77030 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Texas Oncology- Mckinney | McKinney | Texas | 75071 | United States |
| Texas Oncology - Northeast Texas | Paris | Texas | 75460-5004 | United States |
| Gundersen Health System | La Crosse | Wisconsin | 54601 | United States |
| Universite Catholique de Louvain Cliniques Universitaires Saint Luc | Brussels | 1200 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| Jessa Ziekenhuis - Campus Virga Jesse | Hasselt | 3500 | Belgium |
| Centre Hospitalier Universitaire de Liege - Sart Tilman | Liège | 4000 | Belgium |
| Odense Universitetshospital | Odense C | 5000 | Denmark |
| Institut Sainte Catherine | Avignon | 84918 | France |
| Centre Hospitalier Universitaire Régional de Lille - Hôpital Albert Calmette | Lille | 59037 | France |
| Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren | Limoges | 87042 | France |
| Centre Hospitalier Universitaire de Montpellier - Val d Aurelle | Montpellier | 34298 | France |
| Hopital Cochin | Paris | 75014 | France |
| Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque | Pessac | 33604 | France |
| Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou | Rennes | 35033 | France |
| Centre Hospitalier de Nantes - Hôpital Nord Laënnec | Saint-Herblain | 44800 | France |
| Hôpital Sainte Musse | Toulon | 83056 | France |
| Centre Hospitalier Universitaire de Toulouse - Hopital Larrey | Toulouse | 31059 | France |
| Universitätsklinikum Köln | Cologne | 50937 | Germany |
| Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main | Frankfurt am Main | 60590 | Germany |
| Asklepios - Fachkliniken München-Gauting | Gauting | 82130 | Germany |
| Azienda Socio Sanitaria Territoriale di Monza Ospedale San Gerardo | Monza (MB) | 20900 | Italy |
| Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi | Naples | 80131 | Italy |
| Azienda Ospedaliera Universitaria San Luigi Gonzaga | Orbassano (TO) | 10043 | Italy |
| Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano | Rome | 00144 | Italy |
| Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis | Amsterdam | 1066 CX | Netherlands |
| Hospital del Mar | Barcelona | Catalonia | 08003 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Catalonia | 08041 | Spain |
| Hospital Clinico Universitario de Santiago | Santiago de Compostela | Galicia | 15706 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | Valencia | 46026 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Gavle Sjukhus | Gävle | 801 87 | Sweden |
| Sahlgrenska Universitetssjukhuset | Gothenburg | 413 45 | Sweden |
| Universitetssjukhuset i Linkoping | Linköping | 581 85 | Sweden |
| Skanes Universitetssjukhus | Lund | 221 85 | Sweden |
| Norrlands Universitetssjukhus | Umeå | 901 85 | Sweden |
| Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi | Ankara | 06560 | Turkey (Türkiye) |
| Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi | Edirne | 22030 | Turkey (Türkiye) |
| Koc Universitesi Hastanesi | Istanbul | 34010 | Turkey (Türkiye) |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 23, 2026 | Apr 9, 2026 | 27 | ||
| Apr 28, 2026 | May 19, 2026 | 28 | ||
| Jun 12, 2026 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000706028 | sotorasib |
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