Squamous and non-squamous, Non-Small Cell Lung
Conditions
Interventions
Participants will be randomized in a 1:1 ratio to either rilvegostomig or pembrolizumab arm.
Sponsors
Hibi Kazushige
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically or cytologically documented NSCLC (non small lung cancer), including all histological subtypes. - Stage IV mNSCLC (metastatic non-small cell lung cancer) (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment. - Absence of sensitizing EGFR (epidermal growth factor) mutations and ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene 1) rearrangements. Negative assay result is required for all non-squamous histology subtypes. - 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 (first line) therapies. - WHO (World Health Organization)/ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1, with no deterioration over the previous 2 weeks prior to baseline at screening and prior to randomization. - Minimum life expectancy of 12 weeks. - Tumor PD-L1 expression of TC 50% or less must be confirmed prior to randomization - At least one lesion not previously irradiated that qualifies as a RECIST 1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1) TL (target lesion) 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 (computed tomography) or MRI (magnetic resonance imaging) and is suitable for accurate repeated measurements. - Adequate organ and bone marrow function
Exclusion criteria
Exclusion criteria: - As judged by the investigator, any severe or uncontrolled systemic diseases, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol. - History of organ transplant. - Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment. - 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. - 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 or surgery (eg, dizziness and signs of increased intracranial pressure) prior to randomization. - Active primary immunodeficiency/active infectious disease(s) - Active tuberculosis infection - Any prior systemic therapy received for advanced or mNSCLC (metastatic non-small cell lung cancer). - Any prior exposure to an anti-TIGIT (T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain) therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms. - Any prior treatment with an anti-PD-1 (programmed cell death protein 1) or anti-PD-L1 (anti-programmed death-ligand 1) agent.
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, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, France, Georgia, Germany, Greece, Ireland, Israel, Italy, Japan, Malaysia, Portugal, Romania, South Korea, Spain, Switzerland, Turkey, UK, USA
Contacts
Public ContactKazushige Hibi
Astrazeneka K.K
Outcome results
None listed