Non-squamous Non-small Cell Lung Cancer
Conditions
Sponsors
Hibi Kazushige
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically or cytologically documented non-squamous NSCLC. - Stage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment. - Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements. - Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L therapies. - Provision of acceptable tumor sample, to confirm tumor PD-L1 expression TC 1% or higher. - At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as 10 mm or more in the longest diameter (except lymph nodes, which must have short axis 15 mm or more) with CT or MRI and is suitable for accurate repeated measurements. - Adequate organ and bone marrow function
Exclusion criteria
Exclusion criteria: - Presence of small cell and neuroendocrine histology components. - Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization. - Any prior systemic therapy received for advanced or mNSCLC. Prior systemic therapy in the neoadjuvant or adjuvant setting and/or definitive radio- or chemoradiotherapy for early-stage disease are allowed, provided that recurrence or progression has occurred > 12 months after the end of treatment. - Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms. - Any prior treatment with an anti-PD-1 or anti-PD-L1 agent. - History of another primary malignancy except for malignancy treated with curative intent with no known active disease 2 years or more before the first dose of study intervention and of low potential risk for recurrence. - Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment. - Active primary immunodeficiency/active infectious disease(s). - Active tuberculosis infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Overall survival (OS) [Time Frame: Up to approximately 5 years] _OS is defined as the time from randomization until the date of death due to any cause. - Progression-free survival (PFS) [Time Frame: Up to approximately 5 years] _PFS is defined as the time from randomization until radiological progression per RECIST 1.1, or death due to any cause (in the absence of progression). | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Netherlands, Norway, Peru, Poland, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States of America, Vietnam
Contacts
Public ContactKazushige Hibi
Astrazeneka K.K
Outcome results
None listed