A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.
A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer (mNSCLC).
Sponsor: AstraZeneca
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression-Free Survival (PFS) (using BICR assessments according to RECIST 1.1)
Time frame: Up to approximately 6 years
Overall Survival (OS), in PD-L1-negative participants.
Time frame: Up to approximately 6 years
Secondary Endpoints
PFS (using BICR assessments according to RECIST 1.1)
OS
PFS (using Investigator assessments according to RECIST 1.1)
Eligibility Criteria
Key Inclusion Criteria: * Histologically or cytologically documented squamous or non-squamous NSCLC. * Stage IV NSCLC (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology 2016), not amenable to curative surgery or radiation. * Absence of sensitizing EGFR mutations and ALK and ROS1 rearrangements. * Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted first-line therapies. Key Exclusion Criteria: * Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. Rare subtypes are excluded. * Spinal cord compression. * Symptomatic brain metastases. Brain metastases may be treated or untreated, but participants must be asymptomatic and off steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and study enrollment. * History of…
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Expert commentary on why this trial matters and what to watch for.
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