A study to investigate safety and efficacy of osimertinib and amivantamab in participants with non-small cell lung cancer with common epidermal growth factor receptor mutations - OSTARA

Study identifier:D5162C00052

ClinicalTrials.gov identifier:NCT05801029

EudraCT identifier:N/A

CTIS identifier:2022-503057-18-00

Recruiting

Official Title

A Phase II, Open-label, Single-arm, Multi-centre Study to Evaluate the Safety and Efficacy of Osimertinib with Amivantamab as First-line Treatment in Participants with Epidermal Growth Factor Receptor Mutation-Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (OSTARA)

Medical condition

Non-small cell lung cancer (NSCLC)

Phase

Phase 2

Healthy volunteers

No

Study drug

Osimertinib, Amivantamab

Sex

All

Estimated Enrollment

80

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 18 Jul 2023
Estimated Primary Completion Date: 07 Oct 2027
Estimated Study Completion Date: 07 Oct 2027

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria