En undersøgelse, der evaluerer sikkerheden, aktiviteten og farmakokinetikken af GDC-6036 i kombination med andre anti-cancerterapier hos deltagere med tidligere ubehandlet avanceret eller metastatisk ikke-småcellet lungekræft med en KRAS G12C-mutation (KRAScendo 170)
5. oktober 2026 opdateret af: Hoffmann-La Roche
Et fase Ib/II, åbent, multicenter-studie, der evaluerer sikkerheden, aktiviteten og farmakokinetikken af GDC-6036 i kombination med andre anti-cancerterapier hos patienter med tidligere ubehandlet avanceret eller metastatisk ikke-småcellet lungekræft med en KRAS G12C Mutation
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
320
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Undersøgelse Kontakt Backup
- Navn: Reference Study ID Number: BO44426 https://forpatients.roche.com/ No attachments to email below.
- Telefonnummer: 888-662-6728 (U.S. and Canada)
- E-mail: global-roche-genentech-trials@gene.com
Studiesteder
-
-
-
Buenos Aires, Argentina, C1280AEB
- Rekruttering
- Hospital Britanico
-
Ciudad Autonoma Buenos Aires, Argentina, C1430EGF
- Rekruttering
- Clinica Adventista Belgrano
-
La Rioja, Argentina, F5300COE
- Rekruttering
- Centro Oncologico Riojano Integral (CORI)
-
-
-
-
New South Wales
-
Concord, New South Wales, Australien, 2139
- Afsluttet
- Concord Repatriation General Hospital
-
-
Victoria
-
Melbourne, Victoria, Australien, 3000
- Rekruttering
- Peter MacCallum Cancer Centre
-
Melbourne, Victoria, Australien, 3004
- Rekruttering
- Alfred Health
-
-
-
-
-
Brussels, Belgien, 1200
- Rekruttering
- Cliniques Universitaires St-Luc
-
Hasselt, Belgien, 3500
- Rekruttering
- Jessa Zkh (Campus Virga Jesse)
-
Namur, Belgien, 5000
- Rekruttering
- Clinique Ste-Elisabeth
-
Roeselare, Belgien, 8800
- Rekruttering
- AZ Delta (Campus Rumbeke)
-
-
-
-
São Paulo
-
Barretos, São Paulo, Brasilien, 14784-400
- Rekruttering
- Hospital de Cancer de Barretos
-
São Paulo, São Paulo, Brasilien, 01246-000
- Rekruttering
- Instituto do Cancer do Estado de Sao Paulo - ICESP
-
-
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8M2
- Rekruttering
- Ottawa Hospital Regional Cancer Centre
-
Toronto, Ontario, Canada, M5G 1Z5
- Aktiv, ikke rekrutterende
- Princess Margaret Cancer Center
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1E2
- Rekruttering
- Jewish General Hospital
-
-
-
-
-
Glasgow, Det Forenede Kongerige, G12 0YN
- Rekruttering
- Beatson West of Scotland Cancer Centre
-
London, Det Forenede Kongerige, EC1A 7BE
- Rekruttering
- Barts & London School of Med
-
-
-
-
California
-
Duarte, California, Forenede Stater, 91010
- Trukket tilbage
- City of Hope National Medical Center
-
Huntington Beach, California, Forenede Stater, 92648
- Trukket tilbage
- City of Hope - Seacliff
-
Irvine, California, Forenede Stater, 92618
- Trukket tilbage
- City of Hope at Irvine Lennar
-
La Jolla, California, Forenede Stater, 92093
- Trukket tilbage
- UCSD Moores Cancer Center
-
Long Beach, California, Forenede Stater, 90813
- Trukket tilbage
- City of Hope - Long Beach Elm
-
-
Connecticut
-
New Haven, Connecticut, Forenede Stater, 06520
- Rekruttering
- Yale Cancer Center
-
-
Florida
-
Fort Myers, Florida, Forenede Stater, 33901-8108
- Rekruttering
- Florida Cancer Specialists - SOUTH - SCRI - PPDS
-
St. Petersburg, Florida, Forenede Stater, 33705-1400
- Rekruttering
- Florida Cancer Specialists - NORTH - SCRI - PPDS
-
West Palm Beach, Florida, Forenede Stater, 33401-3406
- Rekruttering
- Florida Cancer Specialists - EAST - SCRI - PPDS
-
-
New York
-
Mineola, New York, Forenede Stater, 11501
- Rekruttering
- NYU Langone Hospital - Long Island
-
New York, New York, Forenede Stater, 10016
- Rekruttering
- NYU Cancer Center
-
New York, New York, Forenede Stater, 10029
- Rekruttering
- Mount SInai Medical Center
-
The Bronx, New York, Forenede Stater, 10461
- Rekruttering
- Montefiore Medical Center - Montefiore Medical Park
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- Rekruttering
- MD Anderson Cancer Center
-
-
Virginia
-
Blacksburg, Virginia, Forenede Stater, 24060
- Rekruttering
- Oncology & Hematology Associates of Southwest Virginia, Inc
-
Norfolk, Virginia, Forenede Stater, 23502
- Rekruttering
- Virginia Oncology Associates
-
-
-
-
-
Amsterdam, Holland, 1066 CX
- Aktiv, ikke rekrutterende
- NKI The Netherlands Cancer Institute
-
Nijmegen, Holland, 6525 GA
- Rekruttering
- UMC St Radboud
-
-
-
-
-
Haifa, Israel, 3109601
- Rekruttering
- Rambam Medical Center
-
Petah Tikva, Israel, 4941492
- Rekruttering
- Rabin MC
-
Tel Aviv, Israel, 6423906
- Rekruttering
- Tel Aviv Sourasky Medical Ctr
-
-
-
-
Campania
-
Naples, Campania, Italien, 80131
- Trukket tilbage
- Istituto Nazionale Tumori Fondazione G. Pascale
-
-
Lazio
-
Rome, Lazio, Italien, 00168
- Aktiv, ikke rekrutterende
- Policlinico Universitario Agostino Gemelli IRCCS
-
-
Lombardy
-
Milan, Lombardy, Italien, 20133
- Rekruttering
- Irccs Istituto Nazionale Dei Tumori (Int)
-
-
Piedmont
-
Orbassano, Piedmont, Italien, 10043
- Rekruttering
- A.O. Universitaria S. Luigi Gonzaga
-
-
-
-
-
Chiba, Japan, 277-8577
- Rekruttering
- National Cancer Center Hospital East
-
Osaka, Japan, 589-8511
- Rekruttering
- Kindai University Hospital
-
Tokyo, Japan, 104-0045
- Afsluttet
- National Cancer Center Hospital
-
Tokyo, Japan, 135-8550
- Trukket tilbage
- The Cancer Institute Hospital of JFCR
-
Wakayama, Japan, 641-8510
- Trukket tilbage
- Wakayama Medical University Hospital
-
-
-
-
-
Changsha, Kina, 410013
- Rekruttering
- Hunan Cancer Hospital
-
Harbin, Kina, 150081
- Rekruttering
- Harbin Medical University Cancer Hospital
-
Shanghai, Kina, 200433
- Rekruttering
- Shanghai Pulmonary Hospital
-
-
-
-
-
Gda?sk, Polen, 80-214
- Rekruttering
- Uniwersyteckie Centrum Kliniczne
-
Krakow, Polen, 31-202
- Rekruttering
- Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II
-
Olsztyn, Polen, 10-357
- Rekruttering
- Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
-
-
-
-
-
Basel, Schweiz, 4031
- Rekruttering
- Universitätsspital Basel
-
Bern, Schweiz, 3010
- Trukket tilbage
- Inselspital Bern
-
-
-
-
-
Barcelona, Spanien, 08035
- Rekruttering
- Vall d?Hebron Institute of Oncology (VHIO), Barcelona
-
Madrid, Spanien, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre
-
Madrid, Spanien, 28007
- Rekruttering
- Hospital General Universitario Gregorio Marañon
-
Seville, Spanien, 41013
- Rekruttering
- Hospital Universitario Virgen del Rocio
-
Valencia, Spanien, 46010
- Rekruttering
- Hospital Clinico Universitario de Valencia
-
-
Barcelona
-
Badalona, Barcelona, Spanien, 08916
- Rekruttering
- ICO Badalona-H.U. Germans Trias i Pujol
-
-
-
-
-
Gothenburg, Sverige, 411 36
- Rekruttering
- Sahlgrenska University Hospital
-
-
-
-
-
Busan, Sydkorea, 49241
- Rekruttering
- Pusan National University Hospital
-
Seoul, Sydkorea, 05505
- Rekruttering
- Asan Medical Center
-
Seoul, Sydkorea, 03080
- Rekruttering
- Seoul National University Hospital
-
Seoul, Sydkorea, 06351
- Rekruttering
- Samsung Medical Center
-
Seoul, Sydkorea, 08308
- Rekruttering
- Korea University Guro Hospital
-
-
-
-
-
Taichung, Taiwan, 407
- Rekruttering
- Taichung Veterans General Hospital
-
Tainan, Taiwan
- Rekruttering
- National Cheng Kung University Hospital
-
Taipei, Taiwan, 100
- Rekruttering
- National Taiwan Uni Hospital
-
Taoyuan, Taiwan, 333
- Rekruttering
- Chang Gung Medical Foundation - Linkou
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Confirmation of Biomarker eligibility
- Pre-treatment tumor tissue along with an associated pathology report is required for all participants enrolled on study. Representative tumor specimens must be in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or 15 unstained, freshly cut, serial slides. Although 15 slides are required, if only 10 slides are available, the participant may be eligible for the study following consultation with the Sponsor.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Histologically or cytologically documented locally advanced unresectable or metastatic NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
- No prior systemic treatment for advanced unresectable or metastatic NSCLC
- Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Additionally, for participants in cohort D, measurable brain metastases defined as at least 5 millimeters and twice the slice thickness, but less than 20 mm, that is asymptomatic and does not require local therapy at the time of enrollment.
Exclusion Criteria:
- Known concomitant second oncogenic driver with available targeted treatment
- Squamous cell histology NSCLC
- Symptomatic, untreated, or actively progressing CNS metastases (Cohorts A, B, and C)
- Prior treatment with a KRAS G12C inhibitor
- Known hypersensitivity to any of the components of divarasib or pembrolizumab; or known hypersensitivity to pemetrexed, carboplatin, or cisplatin (Cohort B only)
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, active tuberculosis, significant cardiovascular disease within 3 months prior to initiation of study treatment
- History of malignancy other than NSCLC within 5 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate more >90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer
- Uncontrolled tumor related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia
- Co-morbid condition that is an absolute contraindication to treatment with corticosteroids
- Inability or unwillingness to take prophylactic treatments such as corticosteroids, anti-emetics, folic acid, or vitamin B12 supplementation.
- Participants with brain metastases for whom complete surgical resections is clinically appropriate
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Cohort A - Combination Dose Finding + Dose Expansion
Participants will be enrolled in different cohorts to 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. |
Participants will receive divarasib orally (PO), QD on days 1-21 of each 21-day cycle. Participants will receive a 200 mg IV infusion of pembrolizumab Q3W on Day 1 of each 21-day cycle. |
|
Eksperimentel: 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. |
Participants will receive divarasib orally (PO), QD on days 1-21 of each 21-day cycle. Participants will receive a 200 mg IV infusion of pembrolizumab Q3W on Day 1 of each 21-day cycle. Participants will receive IV carboplatin Q3W for four 21-day cycles. Participants will receive IV cisplatin Q3W for four 21-day cycles. Participants will receive IV pemetrexed Q3W. |
|
Eksperimentel: Cohort C - Dose Expansion
Participants enrolled in this cohort will receive one dose level of divarasib QD. |
Participants will receive divarasib orally (PO), QD on days 1-21 of each 21-day cycle. |
|
Eksperimentel: Cohort D - Dose Expansion
Participants enrolled in this cohort will receive one dose level of divarasib QD. |
Participants will receive divarasib orally (PO), QD on days 1-21 of each 21-day cycle. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Procentdel af deltagere med bivirkninger (AES)
Tidsramme: Baseline indtil 60 dage efter den endelige dosis af studiebehandling eller indtil påbegyndelse af en anden anti-kræftbehandling, alt efter hvad der sker først (op til cirka 5 år)
|
Baseline indtil 60 dage efter den endelige dosis af studiebehandling eller indtil påbegyndelse af en anden anti-kræftbehandling, alt efter hvad der sker først (op til cirka 5 år)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ændring fra baseline i symptomatiske bivirkninger, som vurderet gennem brug af pro-ctcae
Tidsramme: Baseline op til cirka 5 år
|
Baseline op til cirka 5 år
|
|
|
Antal deltagere, der rapporterer tilstedeværelse, hyppighed, sværhedsgrad og/eller grad af indgriben i daglig funktion af symptomatiske bivirkninger som vurderet gennem Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Tidsramme: Omkring 5 år
|
Omkring 5 år
|
|
|
Procentdel af deltagere, der rapporterer "hyppig" eller "næsten konstant" diaré i løbet af de første tre behandlingscyklusser i henhold til PRO-CTCAE-kriterierne
Tidsramme: Omkring 5 år
|
Omkring 5 år
|
|
|
Procentdel af deltagere, der rapporterer "svær" eller "meget svær" kvalme eller opkastning i løbet af de tre første behandlingscykler ifølge PRO-CTCAE
Tidsramme: Cirka 5 år
|
Cirka 5 år
|
|
|
Hyppigheden af deltagernes vurdering af graden af gener fra behandlingssymptomer, vurderet gennem brug af det enkeltstående European Organisation for Research and Treatment of Cancer (EORTC) Item List 46 (IL46)
Tidsramme: Ca. 5 år
|
Ca. 5 år
|
|
|
Objective Response Rate (ORR)
Tidsramme: Approximately 5 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 |
Approximately 5 years
|
|
Duration of Response (DOR)
Tidsramme: Approximately 5 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 |
Approximately 5 years
|
|
Progression Free Survival (PFS)
Tidsramme: Approximately 5 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 |
Approximately 5 years
|
|
Plasma or CSF Concentration of Divarasib at Specified Timepoints
Tidsramme: Approximately 5 years
|
Optional CSF samples may be collected at the time of disease progression or at any time during the study for participants who have provided written consent and if collection of CSF sample is deemed clinically feasible. Matched optional plasma samples may be drawn at the same time. |
Approximately 5 years
|
|
Identification of Divarasib Recommended Dose
Tidsramme: Approximately 5 years
|
The recommended dose will be based upon the totality of safety, activity, and PK data. |
Approximately 5 years
|
|
Central Nervous System (CNS) Response
Tidsramme: Approximately 5 years
|
Defined as the percentage of participants who experience a complete response or partial response in the brain, as determined by the investigator according to modified RECIST |
Approximately 5 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Clinical Trials, Hoffmann-La Roche
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. juni 2023
Primær færdiggørelse (Anslået)
29. januar 2032
Studieafslutning (Anslået)
29. januar 2032
Datoer for studieregistrering
Først indsendt
21. februar 2023
Først indsendt, der opfyldte QC-kriterier
28. marts 2023
Først opslået (Faktiske)
29. marts 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. oktober 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Luftvejssygdomme
- Lungesygdomme
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Lungeneoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Karcinom, ikke-småcellet lunge
- Aminosyrer, peptider og proteiner
- Organiske kemikalier
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Uorganiske kemikalier
- Klorforbindelser
- Nitrogenforbindelser
- Koordinationskomplekser
- Guanine
- Hypoxanthines
- Purinoner
- Puriner
- Glutamater
- Aminosyrer, sur
- Aminosyrer
- Aminosyrer, dicarboxylic
- Platinforbindelser
- Pemetrexed
- Carboplatin
- Cisplatin
- pembrolizumab
Andre undersøgelses-id-numre
- BO44426
- 2022-003048-28 (EudraCT nummer)
- 2023 (U.S. NIH-bevilling/kontrakt)
- 2023-507171-22-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .