A Phase Ib/II, Open-Label, Multicenter Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients With Previously Untreated Advanced Or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation

ReclutandoFase 2ClinicalTrials.gov

ID: NCT05789082Tipo: INTERVENTIONALInicio: 20 de jun de 2023Fin estimado: 29 de ene de 2032

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Resumen

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).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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

Intervenciones

drug

Divarasib

Participants will receive divarasib orally (PO), QD on days 1-21 of each 21-day cycle.

drug

Pembrolizumab

Participants will receive a 200 mg IV infusion of pembrolizumab Q3W on Day 1 of each 21-day cycle.

drug

Carboplatin

Participants will receive IV carboplatin Q3W for four 21-day cycles.

drug

Cisplatin

Participants will receive IV cisplatin Q3W for four 21-day cycles.

drug

Pemetrexed

Participants will receive IV pemetrexed Q3W.

Ubicaciones

Hospital Britanico

Buenos Aires, Argentina

RECRUITING

Clinica Adventista Belgrano

Ciudad Autonoma Buenos Aires, Argentina

RECRUITING

Centro Oncologico Riojano Integral (CORI)

La Rioja, Argentina

RECRUITING

Patrocinadores

PrincipalHoffmann-La Roche

Contactos

Reference Study ID Number: BO44426 https://forpatients.roche.com/

CONTACT

global-roche-genentech-trials@gene.com 888-662-6728 (U.S. and Canada)

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