Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) in treatment naiive patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild type tumour pathology. MedDRA version: 20.0 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 100000004864
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: For inclusion in the study, patients should fulfill the following criteria: - Aged at least 18 years - Documented evidence of Stage IV NSCLC - No sensitizing EGFR mutation or ALK rearrangement - Tumor PD-L1 status, with the Ventana SP263 PD-L1 IHC assay confirmed by a reference laboratory, must be known prior to randomization. - No prior chemotherapy or any other systemic therapy for advanced or metastatic NSCLC. - World Health Organization (WHO) Performance Status of 0 or 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 732 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 360
Exclusion criteria
Exclusion criteria: - Exclusion Criteria: Patients should not enter the study if any of the following exclusion criteria are fulfilled: • Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant • Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids) • Prior exposure to Immunomodulatory therapy (IMT), including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines • Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The efficacy of duvalumab + tremelimumab combination therapy compared to SoC in terms of Progression-Free Survival (PFS) and Overall Survival (OS) in patients with NSCLC The efficacy of durvalumab therapy compared to SoC in terms of Overall Survival (OS) in patients with NSCLC. N=1092 ; Secondary Objective: To assess the efficacy of durvalumab monotherapy and durvalumab + tremelimumab combination therapy in terms of Progression-Free Survival (PFS), Overall Survival (OS) and Objective Response Rate (ORR) compared to SoC ; Primary end point(s): Progression-Free Survival (PFS) using Blinded Independent Central Review (BICR) assessments according to RECIST 1.1 Overall Survival (OS) ; Timepoint(s) of evaluation of this end point: At baseline, after that every 6 weeks for the first 48 weeks relative to the date of randomization, and then every 8 weeks until progression. Assessments for survival every 2 months following treatment discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The efficacy of durvalumab monotherapy compared to SoC in terms of Objective Response rate (ORR) or Progression-Free Survival (PFS) The efficacy of durvalumab + tremelimumab combination therapy compared to SoC in terms of Objective Response rate (ORR) ; Timepoint(s) of evaluation of this end point: For PFS - At baseline, then every 6 weeks for the first 48 weeks relative to the date of randomization, and then every 8 weeks until progression. Assessments for survival every 2 months following treatment discontinuation. | — |
Countries
Australia, Belgium, Canada, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Netherlands, Russian Federation, Spain, Switzerland, Taiwan, Thailand, United States, Vietnam
Contacts
Public ContactInformation Center
AstraZeneca AB
Outcome results
None listed