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Sunitinib in Never-Smokers With Lung Adenocarcinoma
Bu çalışma, hiç sigara içmemiş ve akciğer adenokarsinomu (lung adenocarcinoma) olan hastalarda Sunitinib adlı ilacı incelemiştir. Araştırmaya, EGFR, KRAS ve ALK mutasyonu bulunmayan (wild-type), ileri evre hastalığı olan ve en az bir önceki tedaviyi almış hastalar dahil edilmiştir. Çalışma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Histologically or cytologically confirmed advanced (stage IV or recurrent) non-small cell lung cancer * Adenocarcinoma histology of any variant, including adenosquamous histology * Wild-type for mutations in EGFR, KRAS and ALK * Must have \< 100 cigarettes smoked lifetime OR known to harbor a RET rearrangement OR another potentially targetable genomic alteration as defined per protocol * Disease must be measureable per RECIST 1.1 * At least one prior systemic therapy (adjuvant or palliative) * 18 years or older * Life expectancy of greater than 4 weeks * Adequate ECOG performance status 0 or 1 * Adequate organ function as defined in the protocol * Adequate tumor tissue for the correlative analyses on study, or must undergo a biopsy to obtain adequate tissue Exclusion Criteria: * Pregnant or breastfeeding * Chemotherapy within 4 weeks of entering study, or lack of recover from adverse events to grade 1 or less due to systemic agents administered more than 4 weeks earlier * Radiation therapy within 2 weeks prior to entering study * Major surgery within 4 weeks prior to entering the study * Receiving any other investigational agents * Known untreated, symptomatic or progressive brain metastases; presence of carcinomatous meningitis; history of intracranial hemorrhage or brain metastases requiring chronic steroids * History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib * Use of certain inhibitors and inducers of CYP3A4 * Grade 3 or 4 hemoptysis or hemorrhage within 4 weeks prior to study entry * History of significant bleeding disorder unrelated to cancer * Poorly controlled hypertension * Severe cardiovascular disease * Prolongation of corrected QT interval * History of a different malignancy except: cervical cancer in situ, basal or squamous cell carcinoma of the skin, low risk centralized prostate cancer * HIV positive on combination antiretroviral therapy