PD-L1 inhibition

The key inclusion criteria¹ are –

• Age ≥18 years at screening
• Histologically/cytologically documented Stage IIIB/IIIC NSCLC not amenable for surgical resection or definitive chemoradiation or Stage IV mNSCLC
• No prior chemotherapy or other systemic therapy for first-line Stage IIIB, IIIC or IV disease
• Lacks sensitizing EGFR tumor tissue mutation and ALK and ROS1 rearrangements and has no documented tumor genomic alterations in NTRK, BRAF, RET, MET or other actionable genomic alterations
• ECOG PS of 0–1
• Archival tumor tissue collected prior to signing informed consent form
• Adequate bone marrow reserve and organ function within 7 days before randomization

Reference:

1. Study NCT05687266. ClinicalTrials.gov website.

The key exclusion criteria¹ are –

• History of another primary malignancy^a
• Mixed SCLC and NSCLC histology; sarcomatoid variant of NSCLC
• Persistent toxicities caused by previous anti-cancer therapy not yet improved to grade ≤1 or baseline (with exceptions)
• Active or prior documented autoimmune, connective tissue, or inflammatory disorders (with exceptions)
• Spinal cord compression or brain metastases^b
• History of leptomeningeal carcinomatosis
• Clinically significant corneal disease
• Known active or uncontrolled hepatitis B/C or HIV
• Current or history of (non-infectious) ILD/pneumonitis that required steroids, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening

^aExcept for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk of recurrence.

^bUnless asymptomatic, stable, not requiring steroids for at least 7 days prior to randomization, and a minimum of 2 weeks have elapsed between the end of radiotherapy and study enrollment.