A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation
Reference Study ID Number: BO44426 https://forpatients.roche.com/ Kontakt: Phone: 888-662-6728 (U.S. and Canada) E-Mail: global-roche-genentech-trials@gene.com» Kontaktdaten anzeigen
Studienlocations (3 von 51)
Yale Cancer Center 06520 New Haven United StatesRekrutierend» Google-MapsNYU Langone Hospital - Long Island 11501 Mineola United StatesRekrutierend» Google-MapsNYU Cancer Center; NYU Cancer Institute 10016 New York United StatesRekrutierend» Google-Maps
Hospital Britanico; Oncologia C1280AEB Buenos Aires ArgentinaRekrutierend» Google-MapsClinica Adventista Belgrano; Oncology C1430EGF Ciudad Autonoma Buenos Aires ArgentinaRekrutierend» Google-MapsCentro Oncologico Riojano Integral (CORI) F5300COE La Rioja ArgentinaRekrutierend» Google-MapsConcord Repatriation General Hospital; Concord Cancer Centre 2139 Concord AustraliaRekrutierend» Google-MapsAlfred Health 3004 Melbourne AustraliaRekrutierend» Google-MapsCliniques Universitaires St-Luc 1200 Bruxelles BelgiumRekrutierend» Google-MapsJessa Zkh (Campus Virga Jesse) 3500 Hasselt BelgiumAktiv, nicht rekrutierend» Google-MapsClinique Ste-Elisabeth 5000 Namur BelgiumRekrutierend» Google-MapsAZ Delta (Campus Rumbeke) 8800 Roeselare BelgiumRekrutierend» Google-MapsHospital Nossa Senhora da Conceicao 90040-373 Porto Alegre BrazilZurückgezogen» Google-MapsHospital de Cancer de Barretos 14784-400 Barretos BrazilRekrutierend» Google-MapsInstituto do Cancer do Estado de Sao Paulo - ICESP 01246-000 Sao Paulo BrazilRekrutierend» Google-MapsPrincess Margaret Cancer Center M5G 1Z5 Toronto CanadaAktiv, nicht rekrutierend» Google-MapsJewish General Hospital H3T 1E2 Montreal CanadaAktiv, nicht rekrutierend» Google-MapsHarbin Medical University Cancer Hospital 150081 Harbin ChinaRekrutierend» Google-MapsShanghai Pulmonary Hospital 200433 Shanghai ChinaAktiv, nicht rekrutierend» Google-MapsRambam Medical Center; Oncology 3109601 Haifa IsraelRekrutierend» Google-MapsRabin MC; Davidof Center - Oncology Institute 4941492 Petach Tikva IsraelRekrutierend» Google-MapsTel Aviv Sourasky Medical Ctr; Oncology 6423906 Tel Aviv IsraelRekrutierend» Google-MapsIstituto Nazionale Tumori Fondazione G. Pascale 80131 Napoli ItalyRekrutierend» Google-MapsPoliclinico Universitario Agostino Gemelli IRCCS; UOS Fase 1 00168 Roma ItalyRekrutierend» Google-MapsA.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica 10043 Orbassano ItalyRekrutierend» Google-MapsPusan National University Hospital 602-739 Busan Korea, Republic ofRekrutierend» Google-MapsAsan Medical Center 05505 Seoul Korea, Republic ofRekrutierend» Google-MapsSamsung Medical Center 06351 Seoul Korea, Republic ofRekrutierend» Google-MapsKorea University Guro Hospital 08308 Seoul Korea, Republic ofRekrutierend» Google-MapsNKI The Netherlands Cancer Institute 1066 CX Amsterdam NetherlandsAktiv, nicht rekrutierend» Google-MapsUMC St Radboud 6525 GA Nijmegen NetherlandsRekrutierend» Google-MapsUniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz 80-214 Gda?sk PolandRekrutierend» Google-MapsKrakowski Szpital Specjalistyczny im sw. Jana Paw?a II; Oddzia? Onkologiczny 31-202 Kraków PolandRekrutierend» Google-MapsWarminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii 10-357 Olsztyn PolandRekrutierend» Google-MapsICO Badalona-H.U. Germans Trias i Pujol 08916 Badalona SpainRekrutierend» Google-MapsNEXT Oncology-Hospital Quironsalud Madrid 28223 Pozuelo de Alarcon SpainZurückgezogen» Google-MapsVall d?Hebron Institute of Oncology (VHIO), Barcelona 08035 Barcelona SpainRekrutierend» Google-MapsHospital General Universitario Gregorio Marañon; Servicio de Oncologia 28007 Madrid SpainAktiv, nicht rekrutierend» Google-MapsHospital Universitario Virgen del Rocio; Servicio de Oncologia 41013 Sevilla SpainAktiv, nicht rekrutierend» Google-MapsSahlgrenska University Hospital; Sahlgrenska Clinical Trial unit / Department of Oncology 413 45 Göteborg SwedenRekrutierend» Google-MapsUniversitätsspital Basel; Oncology - Klinische Forschung 4031 Basel SwitzerlandRekrutierend» Google-MapsInselspital Bern; Universitätsklinik für Medizinische Onkologie, Klinische Forschungseinheit 3010 Bern SwitzerlandRekrutierend» Google-MapsNational Cheng Kung University Hospital; Internal Medicine 70403 North Dist. TaiwanRekrutierend» Google-MapsTaichung Veterans General Hospital; Dept of Internal Medicine 407 Taichung TaiwanRekrutierend» Google-MapsNational Taiwan Uni Hospital; Internal Medicine 100 Taipei TaiwanRekrutierend» Google-MapsChang Gung Medical Foundation - Linkou; Chest Dept 333 Taoyuan TaiwanRekrutierend» Google-MapsAdana City Hospital, Medical Oncology 01060 Adana TurkeyZurückgezogen» Google-MapsAnkara Bilkent City Hospital 06490 Ankara TurkeyZurückgezogen» Google-MapsKoc University Hospital; Oncology Istanbul TurkeyZurückgezogen» Google-MapsBeatson West of Scotland Cancer Centre G12 0YN Glasgow United KingdomRekrutierend» Google-MapsBarts & London School of Med; Medical Oncology EC1A 7BE London United KingdomRekrutierend» Google-Maps
1. Percentage of Participants with Adverse Events (AEs) (Time Frame - Baseline until 60 days after the final dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately 3 years))
Secondary outcome:
1. Objective Response Rate (ORR) (Time Frame - Up to approximately 3 years): The percentage of participants who experience a complete response or partial response, as determined by the investigator, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
2. Duration of Response (DOR) (Time Frame - Up to approximately 3 years): The time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
3. Progression Free Survival (PFS) (Time Frame - Up to approximately 3 years): The time from randomization, or date of first treatment for participants enrolled prior to the expansion stage, to the first occurrence of disease progression or death from any cause during the study (whichever occurs first), as determined by the investigator according to RECIST v1.1
4. Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Side Effects as Assessed Through the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) (Time Frame - Up to approximately 3 years)
5. Change from Baseline in Symptomatic Side Effects, as Assessed Through use of the PRO-CTCAE (Time Frame - Baseline up to approximately 3 years)
6. Percentage of Participants Reporting "Frequent" or "Almost Constant" Diarrhea During the First Three Cycles of Treatment According to the PRO-CTCAE Criteria (Time Frame - Up to approximately 3 years)
7. Percentage of Participants Reporting "Severe" or "Very Severe" Nausea or Vomiting During the First Three Cycles of Treatment According to the PRO-CTCAE (Time Frame - Up to approximately 3 years)
8. Frequency of Participant's Response of the Degree they are Troubled with Treatment Symptoms, as Assessed Through use of the Single-item European Organisation for Research and Treatment of Cancer (EORTC) Item List 46 (IL46) (Time Frame - Up to approximately 3 years)
9. Plasma Concentration of Divarasib at Specified Timepoints (Time Frame - At Days 1, 8 and 15 of Cycles 1 and 2; Days 1 and 15 of Cycles 3 and 4; Day 1 of every other Cycle after Cycle 5, until treatment discontinuation (up to approximately 3 years). Each cycle is 21 days.)
10. Identification of Divarasib Recommended Dose (Time Frame - Up to approximately 3 years): The recommended dose will be based upon the totality of safety, activity, and PK data.
Experimental: Cohort A - Combination Dose Finding + Dose Expansion Participants enrolled in this cohort will receive divarasib (different dose levels will be evaluated) once a day (QD) combined with pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W).
During the expansion stage, some participants are planned to be randomized to one divarasib combination dose level; other participants are planned to be randomized to another divarasib combination dose level. Divarasib will be given in combination with pembrolizumab.
Experimental: Cohort B - Combination Dose Finding + Dose Expansion Participants enrolled in this cohort will receive divarasib (different dose levels will be evaluated) QD combined with pembrolizumab 200 mg IV Q3W plus investigator's choice of platinum-based chemotherapy (carboplatin or cisplatin) and pemetrexed.
Divarasib: Participants will receive one of two doses of divarasib orally (PO), QD on days 1-21 of each 21-day cycle.
Pembrolizumab: Participants will receive a 200 mg IV infusion of pembrolizumab Q3W on Day 1 of each 21-day cycle.
Carboplatin: Participants will receive IV carboplatin Q3W for four 21-day cycles.
Cisplatin: Participants will receive IV cisplatin Q3W for four 21-day cycles.
Pemetrexed: Participants will receive IV pemetrexed Q3W.
Quelle: ClinicalTrials.gov
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"A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation"
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