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-DE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-29
• Last Update Posted: 10 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1280

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. Progression > 6 months after the last treatment is required
for participants who have received prior anticancer treatment for earlystage
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 and available therapies (actionable genomic alterations).
Testing is not required for tumors with squamous histology, with
exceptions.
• ECOG PS of 0 or 1
• Archival tumour tissue
• Has adequate bone marrow reserve and organ function within 7 days before randomization
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 576
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 704

Exclusion Criteria

• Mixed small-cell lung cancer and NSCLC histology; sarcomatoid variant of NSCLC
• History of another primary malignancy with exceptions
• Persistent toxicities caused by previous anti-cancer therapy not yet improved to Grade = 1 or baseline, with exceptions.
• Spinal cord compression or clinically or radiologically active brain metastases
• History of leptomeningeal carcinomatosis.
• Known active or uncontrolled hepatitis B or C virus infection.
• Uncontrolled or suspected infection requiring IV antibiotics, antivirals, or antifungals.
• Clinically significant corneal disease
• History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected LD/pneumonitis that cannot be ruled out by imaging at screening.

Study & Design

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