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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503523-25 | Other Identifier | EU CT Number | |
| CA239-0012 | Other Identifier | Bristol-Myers Squibb Protocol ID | |
| 849-021 | Other Identifier | Mirati Therapeutics Protocol ID |
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This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.
CA239-0012 is a phase 2 study of adagrasib monotherapy in which patients are randomized between two dosing regimens. The study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID without regard to food versus 400 mg BID with food) in patients with NSCLC with KRAS G12C mutation and who have received prior treatment with a platinum-based regimen and immune checkpoint inhibitor therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adagrasib 600mg BID | Experimental | Adagrasib 600mg BID without regard to food |
|
| Adagrasib 400mg BID | Experimental | Adagrasib 400mg BID with food |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adagrasib | Drug | KRAS G12C inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). | ORR evaluation of subjects treated with adagrasib 600 mg BID without regard to food versus 400 mg BID with food having NSCLC with KRAS G12C mutation (Study Population) will be completed per blinded independent central radiology (BICR) review. Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from 1st dose of adagrasib until last dose of adagrasib. | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Overall Survival (OS). | Overall survival is defined as time from date of randomization to date of death due to any cause. | 45 months |
| Evaluate Progression Free Survival (PFS). | Progression-free survival is defined as time from date of randomization to date of first progression per RECIST 1.1 or death from any cause, whichever occurs first. |
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Key Inclusion Criteria:
Key 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 - 101 | Santa Rosa | California | 95403 | United States | ||
| Local Institution - 105 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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| 30 months |
| Evaluate Duration of Response (DOR). | Duration of response defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either PD (per BICR review) or death due to any cause, whichever occurs first. | 30 months |
| Safety and tolerability in the study population. | Safety characterized by number of participants with AEs, with abnormal laboratory test results and number of patients modifying or discontinuing study treatment due to an AE:
| 30 months |
| Population pharmacokinetic (PK) Model Derived Area Under the Curve During the Dosing Interval at Steady State (AUCtau,ss). | Sparse concentration data from this study will be pooled with other studies and analyzed using population PK methods to derive individual exposure parameters. Data for this Outcome Measure will not be reported here since ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules. | Pre-dose and 4-6 hours post dose; up to 6 months. |
| Patient-reported symptoms during adagrasib administration from first dose to 28 days after last dose of adagrasib. | Patient reported outcomes (PROs) will be used to assess symptomatic toxicity of adagrasib using the NCI Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Measurement System. PRO items reflect the specific symptom 1) frequency, severity, interference with usual or daily activities, 2) amount, or 3) presence or absence. PRO-CTCAE responses are scored from 0 (low) to 4 (high), or 0/1 for absent/present, and scores for each attribute (frequency, severity and/or interference) are presented descriptively. | 30 months |
| Patient -reported quality of life during adagrasib administration from first dose to End of Treatment visit. | Patient reported quality of life questionnaire will be used to assess five dimensions of patient health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using the 5-Level EQ-5D version (EQ-5D-5L) established by the EuroQol Group. This is presented descriptively, and patient responses correspond to a value of 1 (low) or 5 (high). Additionally, a one- page Visual Analog Scale (VAS) will be provided to patients so they may report their self-rated health from the best (100) and worst (0) health imaginable. | 30 months |
| Kansas City |
| Missouri |
| 64128 |
| United States |
| Local Institution - 100 | Durham | North Carolina | 27705 | United States |
| Local Institution - 106 | Dallas | Texas | 75216-7167 | United States |
| Local Institution - 181 | Salvador | Estado de Bahia | 41950-640 | Brazil |
| Local Institution - 177 | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Local Institution - 182 | Itajaí | Santa Catarina | 88301-220 | Brazil |
| Local Institution - 178 | Belo Horizonte | São Paulo | 30360-680 | Brazil |
| Local Institution - 102 | São Paulo | 01509-900 | Brazil |
| Local Institution - 175 | São Paulo | 01509-900 | Brazil |
| Local Institution - 527 | Zagreb | City of Zagreb | 10000 | Croatia |
| Local Institution - 529 | Rijeka | Primorje-Gorski Kotar County | 51000 | Croatia |
| Local Institution - 559 | Grenoble | Auvergne-Rhône-Alpes | 0 | France |
| Local Institution - 556 | Pessac | Gironde | 33604 | France |
| Local Institution - 553 | Saint-Herblain | Loire-Atlantique | 44800 | France |
| Local Institution - 554 | Angers | Maine-et-Loire | 49933 | France |
| Local Institution - 552 | Lorient | Morbihan | 56322 | France |
| Local Institution - 555 | Nantes | Pays de la Loire Region | 44093 | France |
| Local Institution - 557 | Poitiers | Poitou-Charentes | 86000 | France |
| Local Institution - 561 | Nice | Provence-Alpes-Côte d'Azur Region | 06000 | France |
| Local Institution - 551 | Marseille | Rhône | 13915 | France |
| Local Institution - 560 | Villefranche-sur-Saône | Rhône | 69655 | France |
| Local Institution - 562 | Paris | 75014 | France |
| Local Institution - 558 | Quimper | 29000 | France |
| Local Institution - 550 | Saint-Mandé | 94163 | France |
| Local Institution - 577 | Pátrai | Achaïa | 265 04 | Greece |
| Local Institution - 575 | Athens | Attica | 11528 | Greece |
| Local Institution - 580 | Thessaloniki | North Aegean | 552 36 | Greece |
| Local Institution - 579 | Haidari - Athens | Pella | 12462 | Greece |
| Local Institution - 576 | Thessaloniki | 54639 | Greece |
| Local Institution - 581 | Thessaloniki | 56429 | Greece |
| Local Institution - 625 | Jerusalem | Jerusalem | 9103102 | Israel |
| Local Institution - 629 | Haifa | Tel Aviv | 31048 | Israel |
| Local Institution - 628 | Tel Aviv | Tel Aviv | 64239 | Israel |
| Local Institution - 627 | Haifa | 3109601 | Israel |
| Local Institution - 626 | Tel Aviv | 6423906 | Israel |
| Local Institution - 778 | Pesaro | Pesaro E Urbino | 61122 | Italy |
| Local Institution - 777 | Novara | Piedmont | 28100 | Italy |
| Local Institution - 780 | Candiolo | Torino | 10060 | Italy |
| Local Institution - 779 | Milan | 20141 | Italy |
| Local Institution - 775 | Perugia | 6132 | Italy |
| Local Institution - 776 | Roma | 00144 | Italy |
| Local Institution - 401 | Tōon | Ehime | 791-0295 | Japan |
| Local Institution - 403 | Nishinomiya | Hyôgo [Hyogo] | 663-8501 | Japan |
| Local Institution - 402 | Kashiwa | Tiba [Chiba] | 277-8577 | Japan |
| Local Institution - 400 | Osaka | Ôsaka [Osaka] | 541-8567 | Japan |
| Local Institution - 129 | Colonia Nápoles | Mexico City | 3810 | Mexico |
| Local Institution - 127 | Colonia Roma | Mexico City | 06760 | Mexico |
| Local Institution - 125 | Toluca | 50090 | Mexico |
| Local Institution - 800 | Amsterdam | North Holland | 1066 CX | Netherlands |
| Local Institution - 801 | Utrecht | 3543 AZ | Netherlands |
| Local Institution - 650 | Krakow | Lesser Poland Voivodeship | 30-727 | Poland |
| Local Institution - 651 | Gdynia | Pomeranian Voivodeship | 81-519 | Poland |
| Local Institution - 653 | Lublin | 20-064 | Poland |
| Local Institution - 732 | Cluj-Napoca | Cluj | 400641 | Romania |
| Local Institution - 731 | Ovidiu | Constanța County | 905900 | Romania |
| Local Institution - 729 | Craiova | Dolj | 200385 | Romania |
| Local Institution - 734 | Craiova | Dolj | 200746 | Romania |
| Local Institution - 730 | Timișoara | Timiș County | 300166 | Romania |
| Local Institution - 733 | Iași | 700106 | Romania |
| Local Institution - 725 | Sibiu | 550245 | Romania |
| Local Institution - 728 | Suceava | 720214 | Romania |
| Local Institution - 754 | Nis | Vojvodina | 11000 | Serbia |
| Local Institution - 752 | Kragujevac | Šumadijski Okrug | 34000 | Serbia |
| Local Institution - 327 | Goyang-si | Gyeonggido [Kyonggi-do] | 10408 | South Korea |
| Local Institution - 325 | Seoul | Seoul Teugbyeolsi [Seoul-T'ukpyolshi] | 6351 | South Korea |
| Local Institution - 328 | Seoul | Seoul Teugbyeolsi [Seoul-T'ukp | 06273 | South Korea |
| Local Institution - 326 | Seoul | Seoul Teugbyeolsi [Seoul-T'ukp | 08308 | South Korea |
| Local Institution - 680 | Santiago de Compostela | A Coruña | 15706 | Spain |
| Local Institution - 678 | Málaga | Andalusia | 29010 | Spain |
| Local Institution - 685 | Palma de Mallorca | Balearic Islands | 07120 | Spain |
| Local Institution - 676 | Oviedo | Principality of Asturias | 33011 | Spain |
| Local Institution - 683 | Barcelona | 08025 | Spain |
| Local Institution - 687 | Barcelona | 08028 | Spain |
| Local Institution - 681 | Barcelona | 08035 | Spain |
| Local Institution - 675 | Madrid | 28007 | Spain |
| Local Institution - 679 | Madrid | 28033 | Spain |
| Local Institution - 688 | Madrid | 28040 | Spain |
| Local Institution - 682 | Seville | 41009 | Spain |
| Local Institution - 677 | Valencia | 46010 | Spain |
| Local Institution - 352 | Kaohsuing City | Kaohsiung | 833401 | Taiwan |
| Local Institution - 353 | Taichung | Taichung | 402306 | Taiwan |
| Local Institution - 179 | Taichung | Taichung | 404327 | Taiwan |
| Local Institution - 350 | Taichung | Taichung | 404327 | Taiwan |
| Local Institution - 376 | Muang | Chiang Mai | 50200 | Thailand |
| Local Institution - 377 | Bangkok | Krung Thep Maha Nakhon [Bangko | 10700 | Thailand |
| Local Institution - 375 | Khon Kaen | 40002 | Thailand |
| Local Institution - 378 | Songkhla | 90110 | Thailand |
| Local Institution - 705 | Ankara | Ankara/Cankaya | 06520 | Turkey (Türkiye) |
| Local Institution - 702 | Ankara | Etlik/Ankara | 06010 | Turkey (Türkiye) |
| Local Institution - 709 | Istanbul | Samsun | 34214 | Turkey (Türkiye) |
| Local Institution - 710 | Istanbul | Samsun | 34846 | Turkey (Türkiye) |
| Local Institution - 704 | Ankara | 06200 | Turkey (Türkiye) |
| Local Institution - 701 | Ankara | 06680 | Turkey (Türkiye) |
| Local Institution - 706 | Ankara | 06800 | Turkey (Türkiye) |
| Local Institution - 700 | Edirne | 22030 | Turkey (Türkiye) |
| Local Institution - 707 | Istanbul | 34722 | Turkey (Türkiye) |
| Local Institution - 708 | Izmir | 35100 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| C000718190 | adagrasib |
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