None listed
Conditions
Interventions
Target patient population
Adult patients (age ≥
18 years) with advanced or metastatic (Stage IV) histologically or cytologically
documented EGFR and ALK wild-type NSCLC who are treatment naive.
Duration of treatment
Until specific treatmen
MEDI4736 20 mg/kg via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 doses/cycles, and then continue MEDI4736 20 mg/kg via IV infusion q4w, starting on Week
Tremelimumab 1 mg/kg via IV infusion q4w, starting on Week 0, for up to 4 doses/cycles
Standard of Care therapy
Patients randomized to SoC therapy will receive 1 of the following:
•
Paclitaxel + carboplatin
•
Gemcitabine + cisplatin (squamous patients only)
•
Gemcitabine + carboplatin (squamous patients only)
•
Pemetrexed + cisplatin (non-squamous patients only)
• Pemetrexed + carboplatin (non-squamous patients only)
Sponsors
ASTRAZENECA - PERU,
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age ≥18 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. (For patients aged <20 years and enrolling in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative.) 3. Histologically or cytologically documented Stage IV NSCLC not amendable to curative surgery or radiation (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology; IASLC Staging Manual in Thoracic Oncology). 4. Patients must have tumors that lack activating EGFR mutation (eg, exon 19 deletion or exon 21 L858R, exon 21 L861, exon 18 G719, or exon 20 S7681 mutation) and ALK rearrangement. (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). Note: Please refer to the protocol for aditional inclusion criteria.
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. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study. 3.Mixed small-cell lung cancer and NSCLC histology or not otherwise specified (NSCLC NOS). 4. 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. 5. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of IP. Note: Local treatment of isolated lesions, excluding target lesions, for palliative intent is acceptable. 6. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable. 7. History of allogenic organ transplantation Note: Please refer to the protocol for aditional exclusion criteria.
Countries
Arabia Saudi, Argentina, Brazil, Bulgaria, Chile, Denmark, Finland, Greece, India, Japan, Malasya, Mexico, Peru, Poland, Portugal, Qatar, Romania, Singapore, Sweden, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactGONZALO ERNESTO CASTRO
ASTRAZENECA PERU S.A.
Outcome results
None listed