None listed
Conditions
Interventions
Patients will be randomized in a 1:1:1 ratio to receive treatment either with durvalumab + tremelimumab combination therapy + SoC chemotherapy, durvalumab monotherapy + SoC chemotherapy, or SoC chemot
the detailed dose and schedule is illustrated in Figure 1.
• Note: If a patient’s weight falls to 30 kg or below, the patient should receive weight-based dosing equivalent to 20 mg/kg of durvaluma
Sponsors
AstraZeneca AB,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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)
Countries
Brazil, Bulgaria, Germany, Japan, Korea South, Mexico, Peru, Russian Federation, South Africa, Taiwan, Thailand, Ukraine, United Kindgdom, United States
Contacts
Public ContactGonzalo Ernesto Castro
ASTRAZENECA PERU S.A.
Outcome results
None listed