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| ID | Type | Description | Link |
|---|---|---|---|
| CA239-0013 | Other Identifier | Bristol-Myers Squibb Protocol ID | |
| 849-012 | Other Identifier | Mirati Therapeutics Protocol ID |
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This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 (adagrasib) versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRTX849 | Experimental |
| |
| Docetaxel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRTX849 | Drug | 21 day cycles |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) as Per Blinded Independent Central Review | Progression-free survival (PFS) is defined as the time from randomization to the date of progression or death due to any cause, whichever occurs first. 95% CI was obtained using Brookmeyer and Crowley method. Participants who are not observed to have progressed or died are censored at the date of last evaluable tumor assessment. Disease progression assessed as per RECISIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | From randomization to the date of progression or death due to any cause, whichever occurs first (up to approximately 143 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival is defined as the time from randomization to the date of death due to any cause. | From randomization till death due to any cause (up to approximately 143 weeks) |
| Objective Response Rate (ORR) as Per Blinded Independent Central Review |
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Inclusion Criteria:
Crossover Inclusion Criteria:
Exclusion Criteria:
Crossover Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 012-898 | Cerritos | California | 90703 | United States | ||
| City of Hope - Duarte (Main Campus) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40783289 | Derived | Barlesi F, Yao W, Duruisseaux M, Doucet L, Martinez AA, Gregorc V, Juan-Vidal O, Lu S, De Bondt C, de Marinis F, Linardou H, Kim YC, Jotte R, Felip E, Lo Russo G, Reck M, Michenzie MF, Yang W, Meade JN, Korytowsky B, Mok TSK; KRYSTAL-12 Investigators. Adagrasib versus docetaxel in KRASG12C-mutated non-small-cell lung cancer (KRYSTAL-12): a randomised, open-label, phase 3 trial. Lancet. 2025 Aug 9;406(10503):615-626. doi: 10.1016/S0140-6736(25)00866-9. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adagrasib | Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID). |
| FG001 |
| 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 | Mar 24, 2023 |
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| Docetaxel | Drug | 21 day cycles |
|
|
Objective Response Rate (ORR) is defined as the percent of participants documented to have a confirmed complete response (CR) or partial response (PR). CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis < 10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. All target lesions must be assessed. Disease progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm. |
| From randomization till death or till disease progression or initiation of follow-up anti-cancer therapy or withdrawal of consent prior to minimum efficacy follow-up (up to 143 weeks) |
| Duration of Response (DOR) as Per Blinded Independent Central Review | Duration of Response (DOR) in months is defined as the time from date of the first documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis < 10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. All target lesions must be assessed. Disease progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm. | First documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause (Up to approximately 22 months) |
| 1-Year Survival Rate | Up to 49 months |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Treatment Emergent Adverse Events (TEAEs) are those that first occur or increase in severity on or after the first dose and not more than 28 days after the last dose, and prior to the initiation of subsequent systemic anti-cancer therapy. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks) |
| Number of Participants With Maximum CTCAE Grade Laboratory Abnormality in Hematology Parameters | Blood samples were collected to assess hematology parameters. Adverse events are graded on a scale from 0 to 4 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with Grade 0 being normal Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization. | From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks) |
| Number of Participants With Maximum CTCAE Grade Laboratory Abnormality in Chemistry Parameters | Blood samples were collected to assess chemistry parameters. Adverse events are graded on a scale from 0 to 4 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with Grade 0 being normal Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization. | From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks) |
| Plasma Concentration of Adagrasib | Blood samples were collected for assessment of plasma concentration of Adagrasib. Data for participants for which the dose was reduced after receiving starting dose of 600 mg BID, based on physician decision is presented in separate arms. | Day 1 of Cycle 1 (Pre-Dose and Peak), Cycle 2 (Pre-Dose and Peak), Cycle 3 (Pre-Dose), Cycle 5 (Pre-Dose), Cycle 7 (Pre-Dose) (Each cycle is of 21 days) |
| Change From Baseline in Lung Cancer Symptom Scale (LCSS) Average Total Score | The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire assesses the following 6 symptoms items (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and 3 summary global items (symptom distress, activity level, overall quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The LCSS average total score is sum of items 1 to 9 divided by the total number of items ((sum of items 1 to 9)/9) ranging from 0 to 100 where high score represent worst outcome. Least Square Mean and Confidence Interval are from a repeated measures model on the response variable change from baseline in LCSS average total score. | Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks) |
| Change From Baseline in Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index Score | The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire for average symptom burden index score assesses the following six items (Appetite loss, fatigue, cough, shortness of breath, blood in sputum, pain) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The average symptom burden score is average of all the 6 items ranging from 0 to 100 where high score represent worst outcome. Least square mean and CI are from a repeated measures model on the response variable change from baseline in average symptom burden index score. | Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks) |
| Change From Baseline in Lung Cancer Symptom Scale (LCSS) 3-Item Global Index Score | The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire for average 3-item global index score assesses the following 3 items (Distress/severity of symptoms from lung cancer, impact on normal activities, quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The 3 item global index score is average of all the 3 items ranging from 0 to 100 where high score represent worst outcome. LS mean and CI are from a repeated measures model on the response variable change from baseline in 3-item global index score. | Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks) |
| Change From Baseline at End of Treatment in European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) Visual Analogue Scale Score | The Visual Analogue Score (VAS) is a component of the EQ-5D-5L and assesses the patient's self-rated health using a vertical visual analogue scale where numbered 0 (the worst health you can image) to 100 (the best health you can imageine). The smallest change considered clinically meaningful, is defined as a score difference of 7 points. | Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks) |
| Change From Baseline at End of Treatment in European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) Health Utility Index Score | The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. The EQ-5D-5L health utility index (HUI) is assessed using the Crosswalk algorithm for France based on the individual responses to the 5 EQ-5D-5L domains ranging from -0.594 to 1.000. The smallest change considered clinically meaningful, is defined as a score difference of 0.08 points. Least square mean and CI are from a repeated measures model on the response variable change from baseline in health utility index. | Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks) |
| Duarte |
| California |
| 91010 |
| United States |
| Local Institution - 012-898 D | Glendale | California | 91204 | United States |
| Local Institution - 012-910-A | Huntington Beach | California | 92648 | United States |
| Local Institution - 012-910-C | Irvine | California | 92618 | United States |
| City Of Hope | Long Beach | California | 90808 | United States |
| Local Institution - 012-910-F | Long Beach | California | 90813 | United States |
| Local Institution - 012-910-D | Newport Beach | California | 92663 | United States |
| Local Institution - 012-898 C | Santa Ana | California | 92705 | United States |
| Providence Medical Group - Santa Rosa | Santa Rosa | California | 95403 | United States |
| Local Institution - 012-910-E | Torrance | California | 90505 | United States |
| Local Institution - 012-951-B | Denver | Colorado | 80218 | United States |
| SCL Health - Saint Joseph Hospital Cancer Center | Lafayette | Colorado | 80026 | United States |
| Local Institution - 012-872 | Lone Tree | Colorado | 80124 | United States |
| Local Institution - 012-951-A | Wheat Ridge | Colorado | 80033-6005 | United States |
| Local Institution - 012-562-B | Fleming Island | Florida | 32003 | United States |
| Holy Cross Health Fort Lauderdale - Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| 21st Century Oncology of Jacksonville - North Lee Street | Jacksonville | Florida | 32204 | United States |
| Local Institution - 012-562-D | Jacksonville | Florida | 32204 | United States |
| Local Institution - 012-562-E | Jacksonville | Florida | 32207 | United States |
| Local Institution - 012-562-A | Jacksonville | Florida | 32256 | United States |
| Local Institution - 012-562-C | Jacksonville | Florida | 32256 | United States |
| Local Institution - 012-562-F | Jacksonville | Florida | 32256 | United States |
| Local Institution - 012-562-G | Jacksonville | Florida | 32256 | United States |
| Local Institution - 012-562 | Jacksonville | Florida | 32256 | United States |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | United States |
| Orlando Health University of Florida Health Cancer Center - Head and Neck Center | Orlando | Florida | 32806 | United States |
| USOR - Woodlands Medical Specialists | Pensacola | Florida | 32503 | United States |
| Local Institution - 012-839 | Plantation | Florida | 33322 | United States |
| University Cancer & Blood Center (UCBC) - Athens | Athens | Georgia | 30607 | United States |
| Local Institution - 012-835 - A | Austell | Georgia | 30106 | United States |
| Local Institution - 012-835 - B | Carrollton | Georgia | 30117 | United States |
| Local Institution - 012-835 - C | Cartersville | Georgia | 30121 | United States |
| Local Institution - 012-835 - D | Douglasville | Georgia | 30134 | United States |
| Northwest Georgia Oncology Centers Wellstar - Marietta | Marietta | Georgia | 30060 | United States |
| University of Illinois Hospital & Health Sciences System | Chicago | Illinois | 60612 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Local Institution - 012-972 C | Harvey | Illinois | 60426 | United States |
| Local Institution - 012-972 A | New Lenox | Illinois | 60451 | United States |
| Illinois Cancer Specialists - Niles | Niles | Illinois | 60714 | United States |
| Local Institution - 012-972 B | Orland Park | Illinois | 60462 | United States |
| Goshen Center for Cancer Care | Goshen | Indiana | 46526 | United States |
| Local Institution - 012-569 | Indianapolis | Indiana | 46237 | United States |
| Local Institution - 012-569 - B | Lafayette | Indiana | 47905 | United States |
| Local Institution - 012-569 - C | Lafayette | Indiana | 47905 | United States |
| Local Institution - 012-569 - A | Mooresville | Indiana | 46158 | United States |
| Franciscan Health Munster | Munster | Indiana | 46321 | United States |
| Local Institution - 012-942-B | Chanute | Kansas | 66720 | United States |
| Local Institution - 012-942-C | Dodge City | Kansas | 67801 | United States |
| Local Institution - 012-942-D | El Dorado | Kansas | 67042 | United States |
| Local Institution - 012-942-E | Independence | Kansas | 67301 | United States |
| Local Institution - 012-942-F | Kingman | Kansas | 67068 | United States |
| Local Institution - 012-942-G | Liberal | Kansas | 67901 | United States |
| Local Institution - 012-942-H | McPherson | Kansas | 67460 | United States |
| Local Institution - 012-942-I | Newton | Kansas | 67114 | United States |
| Local Institution - 012-942-J | Parsons | Kansas | 67357 | United States |
| Local Institution - 012-942-K | Pratt | Kansas | 67124 | United States |
| Local Institution - 012-942-L | Salina | Kansas | 67401 | United States |
| Local Institution - 012-942-M | Wellington | Kansas | 67152 | United States |
| Local Institution - 012-820 | Westwood | Kansas | 66205 | United States |
| Local Institution - 012-942-A | Wichita | Kansas | 67208 | United States |
| Local Institution - 012-942 | Wichita | Kansas | 67214 | United States |
| Local Institution - 012-942-N | Winfield | Kansas | 67156 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| Local Institution - 012-911 A | New Orleans | Louisiana | 70112 | United States |
| Tulane University | New Orleans | Louisiana | 70112 | United States |
| Local Institution - 012-954 - A | Kennebunk | Maine | 04043 | United States |
| New England Cancer Specialists - Scarborough | Scarborough | Maine | 04074 | United States |
| Local Institution - 012-954 - B | Topsham | Maine | 04086 | United States |
| Frederick Health | Frederick | Maryland | 21702 | United States |
| Local Institution - 012-974-B | Novi | Michigan | 48374 | United States |
| Local Institution - 012-974-C | Novi | Michigan | 48374 | United States |
| Ascension Providence Cancer Center - Southfield | Southfield | Michigan | 48075 | United States |
| Local Institution - 012-974-A | Southfield | Michigan | 48075 | United States |
| Central Care Cancer Center - Bolivar | Bolivar | Missouri | 65613 | United States |
| Local Institution - 012-841 - A | Billings | Montana | 59101 | United States |
| St. Vincent Healthcare Cancer Centers of Montana | Billings | Montana | 59101 | United States |
| Sisters of Charity of Leavenworth Health St. Marys | Billings | Montana | 59102 | United States |
| Astera Cancer Care - East Brunswick | East Brunswick | New Jersey | 08816 | United States |
| Local Institution - 012-975 - A | Edison | New Jersey | 08820 | United States |
| Local Institution - 012-975 - B | Monroe | New Jersey | 08831 | United States |
| Local Institution - 012-975 - C | Somerset | New Jersey | 08873 | United States |
| Local Institution - 012-975 - D | Somerville | New Jersey | 08876 | United States |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210-2306 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Kettering Health Cancer Center - Main Campus | Kettering | Ohio | 45429 | United States |
| Oregon Oncology Specialists | Salem | Oregon | 97301 | United States |
| Lifespan Cancer Institute - Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Local Institution - 012-960-A | Providence | Rhode Island | 02906 | United States |
| Prisma Health Cancer Institute - Faris Road | Greenville | South Carolina | 29605 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Texas Oncology - Dallas Fort Worth (DFW) - Arlington Cancer Center North | Arlington | Texas | 76012 | United States |
| Texas Oncology - Dallas Fort Worth (DFW) - South Austin | Austin | Texas | 78745 | United States |
| US Oncology Research (USOR) | Irving | Texas | 75063 | United States |
| Texas Oncology - Sherman | Sherman | Texas | 75090 | United States |
| Utah Cancer Specialists - UCS Cancer Center | Salt Lake City | Utah | 84106 | United States |
| Local Institution - 012-976-A | Salt Lake City | Utah | 84124 | United States |
| Local Institution - 012-976-B | Salt Lake City | Utah | 84124 | United States |
| Local Institution - 012-976-C | Salt Lake City | Utah | 84124 | United States |
| Local Institution - 012-976-D | Salt Lake City | Utah | 84124 | United States |
| Local Institution - 012-976-E | Salt Lake City | Utah | 84124 | United States |
| Local Institution - 012-976-F | Salt Lake City | Utah | 84124 | United States |
| Local Institution - 012-976-G | Salt Lake City | Utah | 84124 | United States |
| Local Institution - 012-976-H | Salt Lake City | Utah | 84124 | United States |
| Local Institution - 012-976-I | Salt Lake City | Utah | 84124 | United States |
| Local Institution - 012-814 - B | Arlington | Virginia | 22205 | United States |
| UVA Health - University Hospital | Charlottesville | Virginia | 22908-0674 | United States |
| Local Institution - 012-814 - A | Fairfax | Virginia | 22031 | United States |
| NEXT Virginia | Fairfax | Virginia | 22031 | United States |
| Local Institution - 012-814 - C | Gainesville | Virginia | 20155 | United States |
| Local Institution - 012-814 - D | Leesburg | Virginia | 20176 | United States |
| Local Institution - 012-016 | Mackay | Queensland | 4740 | Australia |
| Local Institution - 012-005 | Bedford Park | 5042 | Australia |
| Local Institution - 012-004 | Clayton | 3168 | Australia |
| Townsville University Hospital | Douglas | 4814 | Australia |
| Local Institution - 012-013 | St Leonards | 2065 | Australia |
| Local Institution - 012-019 | Tweed Heads | 2485 | Australia |
| Cancer Care Wollongong | Wollongong | 2500 | Australia |
| Princess Alexandra Hospital | Woolloongabba | 4102 | Australia |
| Klinikum Klagenfurt Am Worthersee | Klagenfurt | 9020 | Austria |
| Uniklinikum Salzburg | Salzburg | 5020 | Austria |
| Wiener Gesundheitsverbund - Klinik Ottakring | Vienna | 1160 | Austria |
| Universitair Ziekenhuis Brussel | Brussels | 1090 | Belgium |
| Local Institution - 012-157 | Edegem | 2650 | Belgium |
| Local Institution - 012-155 | Ghent | 9000 | Belgium |
| Local Institution - 012-151 | Gilly | 6060 | Belgium |
| Local Institution - 012-158 | Hasselt | 3500 | Belgium |
| Local Institution - 012-152 | Roeselare | 8800 | Belgium |
| Algemeen Ziekenhuis Glorieux Ronse | Ronse | 9600 | Belgium |
| Local Institution - 012-150 | Yvoir | B-5530 | Belgium |
| Local Institution - 012-164 | Hořovice | 268 31 | Czechia |
| Local Institution - 012-162 | Olomouc | 779 00 | Czechia |
| Vseobecna Fakultni Nemocnice v Praze | Prague | 128 08 | Czechia |
| Fakultni nemocnice Bulovka | Praha 8 - Liben | 180 81 | Czechia |
| Local Institution - 012-191-A | Pierre-Bénite | Auvergne-Rhône-Alpes | 69495 | France |
| Local Institution - 012-191-B | Lyon | Rhone | 69004 | France |
| Local Institution - 012-194 | Brest | 29200 | France |
| Hopital Louis Pradel | Bron | 69500 | France |
| Local Institution - 012-193 | Caen | 14033 | France |
| Local Institution - 012-196 | Caen | 14076 | France |
| Centre Hospitalier Intercommunal de Creteil | Créteil | 94000 | France |
| Local Institution - 012-192 | Dijon | 21079 | France |
| LHopital Nord-Ouest (HNO) - Villefranche-sur-Saone | Gleizé | 69400 | France |
| Hopital Michallon | La Tronche | 38700 | France |
| Centre Hospitalier Regional Universitaire de Lille | Lille | 59037 | France |
| Centre Hospitalier Universitaire Dupuytren 1 | Limoges | 87042 | France |
| Institut Paoli-Calmettes | Marseille | 13009 | France |
| Hopital Nord de Marseille | Marseille | 13015 | France |
| Hopital Arnaud de Villeneuve | Montpellier | 34090 | France |
| Hopital Emile Muller | Mulhouse | 68100 | France |
| Local Institution - 012-685 | Nice | 06189 | France |
| Centre Hospitalier de Cornouaille - Hopital Laennec | Quimper | 29107 | France |
| Institut de Cancerologie de lOuest - Saint-Herblain - Site Rene Gauducheau | Saint-Herblain | 44805 | France |
| Hopital Civil | Strasbourg | 67091 | France |
| Local Institution - 012-197 | Strasbourg | 67200 | France |
| Hopital Bretonneau | Tours | 37044 | France |
| Gustave Roussy | Villejuif | 94805 | France |
| Local Institution - 012-219 | Bad Berka | 99437 | Germany |
| Universitatsklinikum Bonn | Bonn | 53127 | Germany |
| Klinikum Koln-Merheim | Cologne | 51109 | Germany |
| Local Institution - 012-210 | Essen | 45136 | Germany |
| Local Institution - 012-214 | Gauting | 82131 | Germany |
| Local Institution - 012-671 | Giessen | 35392 | Germany |
| LungenClinic Grosshansdorf | Grohansdorf | 22927 | Germany |
| Local Institution - 012-215 | Halle | 06120 | Germany |
| Universitatsklinikum Jena | Jena | 07747 | Germany |
| Klinikum Kassel | Kassel | 34125 | Germany |
| Local Institution - 012-224 | Löwenstein | 74245 | Germany |
| Local Institution - 012-216 | Lübeck | 23538 | Germany |
| Local Institution - 012-220 | München | 81925 | Germany |
| Local Institution - 012-672 | Offenbach | 63069 | Germany |
| Pius-Hospital Oldenburg | Oldenburg | 26121 | Germany |
| Henry Dunant Hospital Center | Athens | Attica | 11526 | Greece |
| Local Institution - 012-236 | Athens | 11527 | Greece |
| University General Hospital of Heraklion (PAGNI) | Heraklion | 71110 | Greece |
| Local Institution - 012-235 | Larissa | 41110 | Greece |
| "General Oncology Hospital of Kifisias "Agioi Anargyroi"" | Nea Kifissia | 145 64 | Greece |
| Local Institution - 012-234 | Piraeus | 185 47 | Greece |
| Metropolitan Hospital | Piraeus | 185 47 | Greece |
| BioClinic Thessaloniki | Thessaloniki | 54622 | Greece |
| Local Institution - 012-230 | Thessaloniki | 57001 | Greece |
| Local Institution - 012-500 | Thessaloniki | 57010 | Greece |
| Anassa General Clinic | Volos | 38333 | Greece |
| Humanity & Health Clinical Trial Centre | Central | 0 | Hong Kong |
| Prince of Wales Hospital - Hong Kong | Hong Kong | 0 | Hong Kong |
| Hong Kong United Oncology Centre | Kowloon | 0 | Hong Kong |
| Local Institution - 012-242 | Budapest | 1083 | Hungary |
| Local Institution - 012-244 | Budapest | 1121 | Hungary |
| Local Institution - 012-241 | Budapest | 1122 | Hungary |
| Local Institution - 012-243 | Gyöngyös | 3200 | Hungary |
| Local Institution - 012-763 | Gyula | 5700 | Hungary |
| Local Institution - 012-759 | Székesfehérvár | 8000 | Hungary |
| Reformatus Pulmonologiai Centrum | Törökbálint | 2045 | Hungary |
| The Meath Foundation | Tallaght | Dublin | D24 NR04 | Ireland |
| St. Vincents University Hospital | Dublin | 4 | Ireland |
| Beaumont Hospital - Dublin | Dublin | 9 | Ireland |
| St. Jamess Hospital | Dublin | D08 NHY1 | Ireland |
| University Hospital Galway | Galway | H91 YR71 | Ireland |
| University Hospital Limerick | Limerick | V94 F858 | Ireland |
| Local Institution - 012-276 | Alessandria | 15121 | Italy |
| Local Institution - 012-292 | Avellino | 83100 | Italy |
| Local Institution - 012-274 | Aviano | 33081 | Italy |
| Local Institution - 012-275 | Bari | 70124 | Italy |
| Local Institution - 012-765 | Brescia | 25123 | Italy |
| Local Institution - 012-286 | Candiolo | 10060 | Italy |
| Local Institution - 012-284 | Catania | 95122 | Italy |
| Local Institution - 012-282 | Catania | 95123 | Italy |
| Local Institution - 012-762 | Florence | 50134 | Italy |
| Local Institution - 012-273 | Genova | 16100 | Italy |
| Local Institution - 012-285 | Genova | 16132 | Italy |
| Local Institution - 012-279 | Lecce | 73100 | Italy |
| "Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST" | Meldola | 47014 | Italy |
| Local Institution - 012-296 | Milan | 20132 | Italy |
| Local Institution - 012-278 | Milan | 20141 | Italy |
| Local Institution - 012-283 | Milan | 20133 | Italy |
| Local Institution - 012-271 | Naples | 80131 | Italy |
| Local Institution - 012-277 | Naples | 80131 | Italy |
| Local Institution - 012-770 | Novara | 28100 | Italy |
| Local Institution - 012-272 | Parma | 43126 | Italy |
| Local Institution - 012-281 | Perugia | 06132 | Italy |
| Local Institution - 012-766 | Pesaro | 61122 | Italy |
| Local Institution - 012-767 | Ravenna | 48121 | Italy |
| Local Institution - 012-295 | Roma | 00144 | Italy |
| Local Institution - 012-758 | Verona | 37126 | Italy |
| Local Institution - 012-306 | Amsterdam | 1081 HV | Netherlands |
| Amphia Ziekenhuis - Breda Molengracht | Breda | 4818 CK | Netherlands |
| Local Institution - 012-300 | Maastricht | 6229 HX | Netherlands |
| Local Institution - 012-630 | Nijmegen | 6525 GA | Netherlands |
| Local Institution - 012-308 | The Hague | 2545 AA | Netherlands |
| Local Institution - 012-307 | Utrecht | 3543 AZ | Netherlands |
| Universitair Medisch Centrum Utrecht | Utrecht | 3584 CX | Netherlands |
| Instytut MSF | Lodz | 90-302 | Poland |
| Local Institution - 012-321 | Lublin | 20-064 | Poland |
| Local Institution - 012-760 | Lublin | 20-093 | Poland |
| Local Institution - 012-325 | Otwock | 05-400 | Poland |
| Local Institution - 012-320 | Rzeszów | 35-922 | Poland |
| Local Institution - 012-324 | Skorzewo | 60-185 | Poland |
| Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu | Torun | 87-100 | Poland |
| Local Institution - 012-322 | Warsaw | 02-781 | Poland |
| Wojskowy Instytut Medyczny | Warsaw | 04-349 | Poland |
| Unidade Local de Saude de Almada-Seixal, E. P. E (Hospital Garcia de Orta) | Almada | 2805-267 | Portugal |
| Unidade Local de Saude de Braga, E. P. E (Hospital de Braga) | Braga | 4710-243 | Portugal |
| Local Institution - 012-330 | Coimbra | 3000-075 | Portugal |
| Local Institution - 012-645 | Coimbra | 3000-075 | Portugal |
| Local Institution - 012-333 | Guimarães | 4835-044 | Portugal |
| Local Institution - 012-642 | Lisbon | 1099-023 | Portugal |
| Local Institution - 012-338-A | Lisbon | 1350-352 | Portugal |
| The Champalimaud Centre for the Unknown | Lisbon | 1400-038 | Portugal |
| Local Institution - 012-338 | Lisbon | 1998-018 | Portugal |
| Unidade Local de Saude de Loures-Odivelas, EPE (Hospital Beatriz Angelo) | Loures | 2674-514 | Portugal |
| Hospital CUF Porto | Porto | 14341 | Portugal |
| Local Institution - 012-331 | Porto | 4099-001 | Portugal |
| Local Institution - 012-339 | Porto | 4200-072 | Portugal |
| Unidade Local de Saude de Entre Douro e Vouga, E. P. E | Santa Maria da Feira | 4520-211 | Portugal |
| Unidade Local de Saude da Arrabida, E. P. E (Centro Hospitalar de Setubal) | Setúbal | 2910-443 | Portugal |
| Unidade Local de Saude de Gaia/Espinho, E. P. E | Vila Nova de Gaia | 4434-502 | Portugal |
| Puerto Rico Medical Research Center | San Juan | 00919 | Puerto Rico |
| FDI Clinical Research (Fundacion de Investigacion de Diego) - San Juan | San Juan | 00927 | Puerto Rico |
| PanOncology Trials - Rio Piedras Medical Center | San Juan | 00935 | Puerto Rico |
| Spitalul Jude�ean de Urgen�a dr. Constantin Opri� Baia Mare | Baia Mare | 430031 | Romania |
| SC Policlinica de Diagnostic Rapid SA | Brasov | 500152 | Romania |
| Centrul Oncologic Sanador | Bucharest | 010991 | Romania |
| Local Institution - 012-342 | Bucharest | 022328 | Romania |
| Local Institution - 012-344 | Cluj-Napoca | 400015 | Romania |
| Local Institution - 012-340 | Cluj-Napoca | 400641 | Romania |
| Oncolab Craiova | Craiova | 200385 | Romania |
| Local Institution - 012-343 | Craiova | 200746 | Romania |
| Local Institution - 012-513 | Iași | 700106 | Romania |
| Ovidius Clinical Hospital | Ovidiu | 905900 | Romania |
| Oncocenter - Oncologie Clinica | Timișoara | 300166 | Romania |
| SC OncoMed SRL | Timișoara | 300239 | Romania |
| Evimed Oncology Clinic | Chelyabinsk | 454048 | Russia |
| "Budgetary Healthcare Institution of the Udmurt Republic "Republican Clinical Oncological Dispensary n.a. Sergey Grigoryevich Pr | Izhevsk | 426067 | Russia |
| "Regional Budgetary Healthcare Institution "G.E. Ostroverkhov Kursk Oncology Scientific and Clinical Center" of the Healthcare C | Kislino Village | 305524 | Russia |
| VitaMed - Moscow | Moscow | 121309 | Russia |
| University Headache Clinic | Moscow | 121467 | Russia |
| State Budgetary Healthcare Institution of the Nizhny Novgorod Region Clinical Diagnostic Center | Nizhny Novgorod | 603006 | Russia |
| "Limited Liability Company Medical Sanitary Unit "Clinicist-Clinic Pretor"" | Novosibirsk | 630099 | Russia |
| "Budgetary Healthcare Institution of Omsk region "Clinical Oncologic Dispensary"" | Omsk | 644013 | Russia |
| Local Institution - 012-355 | Saint Petersburg | 197022 | Russia |
| "Federal State Budgetary Institution "Influenza Research Institute named after N.N. A.A. Smorodintsev" of the Ministry of Health | Saint Petersburg | 197376 | Russia |
| Local Institution - 012-354 | Saint Petersburg | 197758 | Russia |
| Local Institution - 012-093 | Singapore | 168583 | Singapore |
| Raffles Hospital | Singapore | 188770 | Singapore |
| Icon Cancer Centre Farrer Park | Singapore | 217562 | Singapore |
| Oncocare Cancer Centre | Singapore | 258499 | Singapore |
| Parkway Cancer Centre - Gleneagles Hospital | Singapore | 258500 | Singapore |
| Local Institution - 012-111 | Busan | 48108 | South Korea |
| Local Institution - 012-522 | Busan | 49241 | South Korea |
| Local Institution - 012-101 | Busan | 602702 | South Korea |
| Chungbuk National University Hospital | Cheongju-si | 28644 | South Korea |
| Local Institution - 012-110 | Daegu | 41404 | South Korea |
| Local Institution - 012-523 | Daegu | 42601 | South Korea |
| Local Institution - 012-100 | Hwasun-gun | 58128 | South Korea |
| Local Institution - 012-103 | Incheon | 21565 | South Korea |
| Local Institution - 012-102 | Junggu | 400-712 | South Korea |
| Local Institution - 012-520 | Seongnam-si | 13496 | South Korea |
| Local Institution - 012-112 | Seongnam-si | 13620 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Local Institution - 012-118 | Seoul | 03722 | South Korea |
| Local Institution - 012-106 | Seoul | 05080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| The Catholic University of Korea - Seoul St. Marys Hospital | Seoul | 06591 | South Korea |
| Catholic University of Korea St. Vincents Hospital | Suwon | 16247 | South Korea |
| Local Institution - 012-107 | Suwon | 16499 | South Korea |
| Clinica Universidad de Navarra - Pamplona | Pamplona | Navarre | 31008 | Spain |
| Local Institution - 012-613 | A Coruña | 15006 | Spain |
| Local Institution - 012-769 | Alicante | 3010 | Spain |
| Hospital Germans Trias i Pujol | Badalona | 08916 | Spain |
| Local Institution - 012-776 | Barakaldo | 48903 | Spain |
| Hospital del Mar - Parc de Salut Mar | Barcelona | 08003 | Spain |
| Local Institution - 012-614 | Barcelona | 08028 | Spain |
| Local Institution - 012-612 | Barcelona | 08035 | Spain |
| Local Institution - 012-600 | Barcelona | 08036 | Spain |
| Local Institution - 012-621 | Córdoba | 14004 | Spain |
| Local Institution - 012-764 | Girona | 17007 | Spain |
| Local Institution - 012-616 | Granada | 18014 | Spain |
| Complejo Hospitalario Universitario Insular Materno Infantil | Las Palmas de Gran Canaria | 35016 | Spain |
| Hospital de Leon | León | 24071 | Spain |
| Local Institution - 012-615 | Lugo | 27003 | Spain |
| Local Institution - 012-607 | Madrid | 28007 | Spain |
| Clinica Universidad de Navarra - Madrid | Madrid | 28027 | Spain |
| Local Institution - 012-606 | Madrid | 28034 | Spain |
| Local Institution - 012-601 | Madrid | 28040 | Spain |
| Local Institution - 012-609 | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Local Institution - 012-626 | Majadahonda | 28222 | Spain |
| Local Institution - 012-608 | Málaga | 29009 | Spain |
| Local Institution - 012-602 | Palma de Mallorca | 07120 | Spain |
| Local Institution - 012-604 | Santander | 39008 | Spain |
| Local Institution - 012-629 | Seville | 41013 | Spain |
| Consorci Hospital General Universitari de Valencia | Valencia | 46014 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Local Institution - 012-603 | Zaragoza | 50009 | Spain |
| Universitatsspital Basel | Basel | 4031 | Switzerland |
| Spital Simmental-Thun-Saanenland | Thun | 3604 | Switzerland |
| Kantonsspital Winterthur | Winterthur | 8401 | Switzerland |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | B9 5SS | United Kingdom |
| NHS Lothian | Edinburgh | EH4 2XU | United Kingdom |
| NHS Greater Glasgow and Clyde | Glasgow | G12 0XH | United Kingdom |
| University Hospitals of Leicester NHS Trust | Leicester | LE1 5WW | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| BMS Clinical Trial Patient Recruiting | View source |
| Docetaxel |
Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m^2 over 1 hour or according to institutional practices. |
| Safety Population | Participants who received at least one dose of study treatment. |
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| Cross Over | Eligible participants receiving Docetaxel based on physician switched to treatment with Adagrasib |
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Adagrasib | Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID). |
| BG001 | Docetaxel | Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m^2 over 1 hour or according to institutional practices. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression-Free Survival (PFS) as Per Blinded Independent Central Review | Progression-free survival (PFS) is defined as the time from randomization to the date of progression or death due to any cause, whichever occurs first. 95% CI was obtained using Brookmeyer and Crowley method. Participants who are not observed to have progressed or died are censored at the date of last evaluable tumor assessment. Disease progression assessed as per RECISIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | Intent-To-Treat Population includes all participants who are randomized into this study. | Posted | Median | 95% Confidence Interval | months | From randomization to the date of progression or death due to any cause, whichever occurs first (up to approximately 143 weeks) |
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| Secondary | Overall Survival (OS) | Overall survival is defined as the time from randomization to the date of death due to any cause. | Not Posted | Dec 2025 | From randomization till death due to any cause (up to approximately 143 weeks) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) as Per Blinded Independent Central Review | Objective Response Rate (ORR) is defined as the percent of participants documented to have a confirmed complete response (CR) or partial response (PR). CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis < 10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. All target lesions must be assessed. Disease progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm. | Intent-To-Treat Population includes all participants who are randomized into this study. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization till death or till disease progression or initiation of follow-up anti-cancer therapy or withdrawal of consent prior to minimum efficacy follow-up (up to 143 weeks) |
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| Secondary | Duration of Response (DOR) as Per Blinded Independent Central Review | Duration of Response (DOR) in months is defined as the time from date of the first documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis < 10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. All target lesions must be assessed. Disease progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm. | Intent-To-Treat Population with Confirmed CR or PR. Intent-To-Treat Population includes all participants who are randomized into this study. | Posted | Median | 95% Confidence Interval | months | First documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause (Up to approximately 22 months) |
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| Secondary | 1-Year Survival Rate | Not Posted | Dec 2025 | Up to 49 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Treatment Emergent Adverse Events (TEAEs) are those that first occur or increase in severity on or after the first dose and not more than 28 days after the last dose, and prior to the initiation of subsequent systemic anti-cancer therapy. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | Safety Population included all the participants who received at least one dose of the study drug. Docetaxel arm do not include adverse events after initiation of crossover Adagrasib treatment. | Posted | Count of Participants | Participants | From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks) |
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| Secondary | Number of Participants With Maximum CTCAE Grade Laboratory Abnormality in Hematology Parameters | Blood samples were collected to assess hematology parameters. Adverse events are graded on a scale from 0 to 4 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with Grade 0 being normal Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization. | Safety Population included all the participants who received at least one dose of the study drug. Docetaxel arm do not include adverse events after initiation of crossover Adagrasib treatment. | Posted | Count of Participants | Participants | From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks) |
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| Secondary | Number of Participants With Maximum CTCAE Grade Laboratory Abnormality in Chemistry Parameters | Blood samples were collected to assess chemistry parameters. Adverse events are graded on a scale from 0 to 4 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with Grade 0 being normal Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization. | Safety Population included all the participants who received at least one dose of the study drug. Docetaxel arm do not include adverse events after initiation of crossover Adagrasib treatment. | Posted | Count of Participants | Participants | From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks) |
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| Secondary | Plasma Concentration of Adagrasib | Blood samples were collected for assessment of plasma concentration of Adagrasib. Data for participants for which the dose was reduced after receiving starting dose of 600 mg BID, based on physician decision is presented in separate arms. | The PK evaluable population is defined as patients who received at least one dose of active study drug and had at least one blood sample collected to assess PK concentrations | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 1 of Cycle 1 (Pre-Dose and Peak), Cycle 2 (Pre-Dose and Peak), Cycle 3 (Pre-Dose), Cycle 5 (Pre-Dose), Cycle 7 (Pre-Dose) (Each cycle is of 21 days) |
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| Secondary | Change From Baseline in Lung Cancer Symptom Scale (LCSS) Average Total Score | The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire assesses the following 6 symptoms items (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and 3 summary global items (symptom distress, activity level, overall quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The LCSS average total score is sum of items 1 to 9 divided by the total number of items ((sum of items 1 to 9)/9) ranging from 0 to 100 where high score represent worst outcome. Least Square Mean and Confidence Interval are from a repeated measures model on the response variable change from baseline in LCSS average total score. | Intent-To-Treat Population includes all participants who are randomized into this study. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a sclae | Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks) |
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| Secondary | Change From Baseline in Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index Score | The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire for average symptom burden index score assesses the following six items (Appetite loss, fatigue, cough, shortness of breath, blood in sputum, pain) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The average symptom burden score is average of all the 6 items ranging from 0 to 100 where high score represent worst outcome. Least square mean and CI are from a repeated measures model on the response variable change from baseline in average symptom burden index score. | Intent-To-Treat Population includes all participants who are randomized into this study. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a sclae | Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks) |
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| Secondary | Change From Baseline in Lung Cancer Symptom Scale (LCSS) 3-Item Global Index Score | The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire for average 3-item global index score assesses the following 3 items (Distress/severity of symptoms from lung cancer, impact on normal activities, quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The 3 item global index score is average of all the 3 items ranging from 0 to 100 where high score represent worst outcome. LS mean and CI are from a repeated measures model on the response variable change from baseline in 3-item global index score. | Intent-To-Treat Population includes all participants who are randomized into this study. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a sclae | Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks) |
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| Secondary | Change From Baseline at End of Treatment in European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) Visual Analogue Scale Score | The Visual Analogue Score (VAS) is a component of the EQ-5D-5L and assesses the patient's self-rated health using a vertical visual analogue scale where numbered 0 (the worst health you can image) to 100 (the best health you can imageine). The smallest change considered clinically meaningful, is defined as a score difference of 7 points. | Intent-To-Treat Population includes all participants who are randomized into this study. LS mean and CI are from a repeated measures model on the response variable change from baseline in visual analogue scale. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks) |
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| Secondary | Change From Baseline at End of Treatment in European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) Health Utility Index Score | The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. The EQ-5D-5L health utility index (HUI) is assessed using the Crosswalk algorithm for France based on the individual responses to the 5 EQ-5D-5L domains ranging from -0.594 to 1.000. The smallest change considered clinically meaningful, is defined as a score difference of 0.08 points. Least square mean and CI are from a repeated measures model on the response variable change from baseline in health utility index. | Intent-To-Treat Population includes all participants who are randomized into this study. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks) |
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All cause mortality and non serious adverse events were reported from first first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks). Serious adverse events were collected from date of signing of informed consent form till 28 days after last dose (Up to approximately 111 weeks).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
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 | Adagrasib | Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID). | 126 | 301 | 149 | 298 | 292 | 298 |
| EG001 | Docetaxel | Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m^2 over 1 hour or according to institutional practices. | 53 | 152 | 50 | 140 | 129 | 140 |
| EG002 | Crossover Adagrasib | Eligible participants receiving Docetaxel earlier in the study switched to Adagrasib based on physician decision. Participants were administered with Adagrasib orally at a starting dose of 600 mg twice a day (BID). | 15 | 44 | 20 | 44 | 43 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
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| Febrile bone marrow aplasia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
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| Myelosuppression | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
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| Splenic infarction | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | 26.0 | Systematic Assessment |
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| Aortic valve stenosis | Cardiac disorders | 26.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | 26.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | 26.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | 26.0 | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | 26.0 | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | 26.0 | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | 26.0 | Systematic Assessment |
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| Pericarditis | Cardiac disorders | 26.0 | Systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | 26.0 | Systematic Assessment |
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| Dyschromatopsia | Eye disorders | 26.0 | Systematic Assessment |
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| Photophobia | Eye disorders | 26.0 | Systematic Assessment |
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| Retinopathy | Eye disorders | 26.0 | Systematic Assessment |
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| Vision blurred | Eye disorders | 26.0 | Systematic Assessment |
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| Visual impairment | Eye disorders | 26.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | 26.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | 26.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Gastrointestinal toxicity | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 26.0 | Systematic Assessment |
| |
| Death | General disorders | 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 26.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 26.0 | Systematic Assessment |
| |
| Hyperthermia | General disorders | 26.0 | Systematic Assessment |
| |
| Malaise | General disorders | 26.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | 26.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 26.0 | Systematic Assessment |
| |
| Pain | General disorders | 26.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 26.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Hepatic cytolysis | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Hepatic ischaemia | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | 26.0 | Systematic Assessment |
| |
| Abscess jaw | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 26.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Myelitis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Viral pericarditis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | 26.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 26.0 | Systematic Assessment |
| |
| Blood bilirubin unconjugated increased | Investigations | 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 26.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | 26.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | 26.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 26.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Lymphangiosis carcinomatosa | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Paraneoplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of the oral cavity | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.0 | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Coma | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Bradyphrenia | Psychiatric disorders | 26.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | 26.0 | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Glomerulonephritis membranoproliferative | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Hypersensitivity pneumonitis | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | 26.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 26.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | 26.0 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | 26.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | 26.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 26.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 26.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | 26.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | 26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 26.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 26.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| Dec 20, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009362 | Neoplasm Metastasis |
| 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 |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718190 | adagrasib |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or other Pacific Islander |
|
| Other |
|
| Not Reported |
|
| Missing |
|
| OG001 | Docetaxel | Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m^2 over 1 hour or according to institutional practices. |
|
|
|
| OG001 | Docetaxel | Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m^2 over 1 hour or according to institutional practices. |
|
|
| OG002 | Crossover Adagrasib | Eligible participants receiving Docetaxel earlier in the study switched to Adagrasib based on physician decision. Participants were administered with Adagrasib orally at a starting dose of 600 mg twice a day (BID). |
|
|
| OG002 | Crossover Adagrasib | Eligible participants receiving Docetaxel earlier in the study switched to Adagrasib based on physician decision. Participants were administered with Adagrasib orally at a starting dose of 600 mg twice a day (BID). |
|
|
| OG002 | Crossover Adagrasib | Eligible participants receiving Docetaxel earlier in the study switched to Adagrasib based on physician decision. Participants were administered with Adagrasib orally at a starting dose of 600 mg twice a day (BID). |
|
|
| Adagrasib 400 mg BID |
Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered with study treatment in 3-week cycle and were administered 400 mg BID Adagrasib orally. |
| OG003 | Adagrasib 600 mg QD | Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered with study treatment in 3-week cycle and were administered 600 mg QD Adagrasib orally. |
| OG004 | Adagrasib 600 mg BID | Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered with study treatment in 3-week cycle and were administered 600 mg BID Adagrasib orally. |
|
|
| Docetaxel |
Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m^2 over 1 hour or according to institutional practices. |
|
|
Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m^2 over 1 hour or according to institutional practices. |
|
|
Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m^2 over 1 hour or according to institutional practices. |
|
|
|
|
| OG001 |
| Docetaxel |
Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m^2 over 1 hour or according to institutional practices. |
|
|
|
|
|
|
|
|