Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations

Phase 1

• Conditions: SCLC; MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-004606-21-HU
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-23
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

•Participants = 18 years at screening
•Participants with stage IIIB or IIIC, histologically or cytologically documented NSCLC, not amenable for surgical resection or definitive chemoradiation, who have not received prior chemotherapy or other systemic therapy for first-line Stage IIIB, IIIC or IV NSCLC
•Lacks sensitising EGFR tumour tissue mutation and ALK and ROS1 rearrangements and has no documented tumour genomic alterations in NTRK, BRAF, RET, MET or other actionable driver oncogenes with approved therapies (actionable genomic alterations).
•ECOG PS of 0 or 1
•Archival tumour tissue collected prior to signing of ICF
•Has adequate bone marrow reserve and organ function within 7 days before randomisation
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 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 550

Exclusion Criteria

•Mixed small-cell lung cancer and NSCLC histology; sarcomatoid variant of NSCLC
•Persistent toxicities caused by previous anti-cancer therapy not yet improved to Grade = 1 or baseline
•Spinal cord compression or brain metastases
•History of leptomeningeal carcinomatosis.
•Known active or uncontrolled hepatitis B or C virus infection.
•Clinically significant corneal disease
•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

Study & Design

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