NCT07098338

A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)

An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 278 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, multi-center, open-label platform study evaluating novel combination treatment options in participants with locally advanced or metastatic NSCLC. The study will consist of several sub-studies, each evaluating the safety, tolerability, and preliminary antitumour activity of various treatment combinations. This study will be conducted in approximately 80 centers globally across 10 countries.

Detailed description

The master protocol will include 3 sub-studies, each focused on a specific disease population. * Sub-study 1 will investigate rilvegostomig± ramucirumab in 1L non-actionable genomic alterations (AGA) NSCLC with PD-L1 ≥50%. * Sub-study 2 will investigate rilvegostomig + ramucirumab in 1L non-actionable genomic alterations (AGA) NSCLC with PD-L1 1-49%. * Sub-study 3 will investigate Dato-DXd + ramucirumab ± rilvegostomig in 2/3L AGA+ Each sub-study may include 2 parts (unless stated in the individual sub study protocols): Part A: one or more Safety Run-in cohort(s), and Part B: one or more Dose Expansion cohort(s).

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Rilvegostomig	Rilvegostomig will be administered as IV infusion.
DRUG	Ramucirumab	Ramucirumab will be administered as IV infusion.
DRUG	Dato-DXd	Dato-DXd will be administered as IV infusion.

Timeline

• Start date: 2025-08-07
• Primary completion: 2029-04-06
• Completion: 2029-04-06
• First posted: 2025-08-01
• Last updated: 2026-02-05

Locations

63 sites across 9 countries: United States, Australia, Canada, China, Japan, Singapore, South Korea, Taiwan, Thailand

Regulatory

• FDA-regulated drug study