A PHASE III, RANDOMIZED, MULTI-CENTER, OPEN-LABEL, COMPARATIVE GLOBAL STUDY TO DETERMINE THE EFFICACY OF DURVALUMAB OR DURVALUMAB AND TREMELIMUMAB IN COMBINATION WITH PLATINUM-BASED CHEMOTHERAPY FOR FIRST-LINE TREATMENT IN PATIENTS WITH METASTATIC NON SMALL-CELL LUNG CANCER (NSCLC) (POSEIDON)

AstraZeneca AB,0 个研究点目标入组 35 人开始时间: 2017年9月14日最近更新: 2023年11月13日

适应症

试验速览

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•1.Age ≥18 years at the time of screening. In Japan, patients must be ≥20 years at the time of screening.
•2.Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
•3.Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology; IASLC Staging Manual in Thoracic Oncology).
•4.Patients must have tumors that lack activating EGFR mutations (eg, exon 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation) and ALK fusions. If a patient has squamous histology or is known to have a tumor with a KRAS mutation, then EGFR and ALK testing is not required.
•5.No prior chemotherapy or any other systemic therapy for metastatic NSCLC. Patients who have received prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred >12 months from end of last therapy (see exclusion criterion 7).
•Note: Please for additional inclusion criteria, refer to the protocol (Page: 62-64)

•1.Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
•2.Previous IP assignment in the present study.
•3.Concurrent enrollment in another clinical study, unless it is an observational (non interventional) clinical study or the follow-up period of an interventional study.
•4.Participation in another clinical study with an IP during the last 12 months.
•5.Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant.
•6.Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable.
•7.No radiation therapy is allowed, unless it is 1) definitive radiation that had been administered at least 12 months prior, 2) palliative radiation to brain, with associated criteria for stability or lack of symptoms (see also exclusion criterion 15), or 3) palliative radiation to painful bony lesions (this must comprise less than 30% of the bone marrow).
•Note: Please for additional exclusion criteria, refer to the protocol (Page: 64-67)

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