A study to evaluate Chemotherapy Plus Osimertinib against Chemotherapy Plus Placebo in patients with non-small cell lung cancer (NSCLC) - COMPEL

Study identifier:D5162C00042

ClinicalTrials.gov identifier:NCT04765059

EudraCT identifier:2019-003969-18

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Pemetrexed Chemotherapy Plus Osimertinib Versus Platinum Plus Pemetrexed Chemotherapy Plus Placebo in Patients with EGFRm, Locally Advanced or Metastatic NSCLC who have Progressed Extracranially following First-Line Osimertinib Therapy (COMPEL)

Medical condition

Non-small Cell Lung Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin, Placebo for osimertinib (AZD9291) pemetrexed cisplatin or carboplatin

Sex

All

Actual Enrollment

97

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 12 Sept 2021
Estimated Primary Completion Date: 30 Dec 2024
Estimated Study Completion Date: 30 Dec 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria