A trial to learn if Dato-DXd with rilvegostomig, or rilvegostomig alone, is safe and works compared with pembrolizumab in people who have advanced non-squamous non-small cell lung cancer (NSCLC) with high levels of the PD-L1 protei

Phase 1

• Conditions: ocally-advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high PD-L1 expression (TC = 50%) and without actionable genomic alterations.; MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-505077-32-00
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-11
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 675

Inclusion Criteria

Histologically or cytologically documented non-squamous NSCLC., Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation., Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and abscence of documented local test result for any other known genomic alteration for which there are locally approved targeted first-line therapies., Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers., Known tumour PD-L1 expression status defined as TC = 50%, determined prospectively using the VENTANA PD-L1 (SP263) Assay., At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline., ECOG performance status of 0 or 1, Adequate bone marrow reserve and organ function within 7 days before the first dose of study intervention.

Exclusion Criteria

Prior systemic therapy for advanced/metastatic NSCLC., History of leptomeningeal carcinomatosis, Known clinically significant corneal disease, Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled, History of active primary immunodeficiency, Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant., History of another primary malignancy within 3 years., Active or prior documented autoimmune or inflammatory disorders (with exceptions)., Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease., Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage., History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening, Has severe pulmonary function compromise resulting from intercurrent pulmonary illnesses., Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified