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

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

Status
Approved-not yet active
Cancer Type
Lung Cancer
Trial Phase
Phase II
Eligibility
, Male and Female
Study Type
NCT ID
NCT07098338
Protocol IDs
D6187C00001 (primary)
Study Sponsor
AstraZeneca
NCI Full Details

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.

Objectives

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 2L 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).

Treatment Sites in Georgia

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