Clareo Health | A Clinical Study on the Safety and Efficacy of Debio 0932 in Combination With Standard of Care in Patients With Non-small Cell Lung Cancer [NSCLC]
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Keep this study
Lead
Debiopharm International SA
With
Syneos Health
Part A of this study will determine the Maximum Tolerated Dose of Debio 0932 in combination with cisplatin/pemetrexed and cisplatin/gemcitabine in treatment-naïve patients with Stage IIIb or IV NSCLC, and with docetaxel in previously treated patients with Stage IIIb or IV NSCLC.
Escalating doses of Debio 0932 will be given to subsequent patients in combination with standard doses of these 3 background chemotherapies.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of NSCLC with confirmed squamous or non-squamous tumour histology, without known epidermal growth factor receptor (EGFR) mutation
Advanced or metastatic disease (Stage IIIb or IV)
Patients to be treated with cisplatin/gemcitabine or cisplatin/pemetrexed: No previous systemic treatment with chemotherapy, targeted therapy or investigational agents (except adjuvant therapy if \> 6 months ago); Patients to be treated with docetaxel: ≥ 1 previous treatment with chemotherapy
Measurable disease by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
ECOG performance score 0-1
Life expectancy ≥ 3 months
Adequate bone marrow-, renal- and hepatic function
LVEF ≥ 55% on cardiac ultrasound
You may not be if
Symptomatic brain metastases
Gastro-intestinal disorders that could affect drug absorption (including, but not limited to, major abdominal surgery, significant bowel obstruction, ulcerative colitis, Crohn's disease)
Concurrent treatment with any other systemic anti-cancer therapy
Serious concomitant uncontrolled medical conditions
