Osimertinib After Chemoradiation for Lung Cancer
(LAURA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests osimertinib, a medication for certain lung cancers, in patients with stage III unresectable NSCLC who have specific EGFR mutations. Osimertinib aims to slow or stop cancer growth by blocking a protein involved in cancer cell growth.
Will I have to stop taking my current medications?
The trial requires that you stop taking medications or herbal supplements known to be strong inducers of CYP3A4 at least 3 weeks before starting the study treatment.
Is osimertinib generally safe for humans?
Osimertinib has been studied in various trials for lung cancer, and common side effects include diarrhea, rash, dry skin, and nail issues. Serious side effects occurred in about 28% of patients, and 5.6% stopped treatment due to these effects, but it is generally considered to have a manageable safety profile.12345
How is the drug osimertinib unique for lung cancer treatment?
Osimertinib is unique because it is an oral medication specifically designed to target and inhibit mutations in the epidermal growth factor receptor (EGFR) that are resistant to previous treatments, particularly the T790M mutation in non-small cell lung cancer (NSCLC). This makes it effective for patients who have developed resistance to earlier EGFR-targeted therapies.35678
What data supports the effectiveness of the drug Osimertinib for lung cancer?
Osimertinib has shown effectiveness in treating non-small cell lung cancer (NSCLC) with specific genetic mutations, particularly the EGFR T790M mutation, by significantly prolonging disease-free survival in patients with early-stage cancer and those who have developed resistance to other treatments.34568
Who Is on the Research Team?
Shun Lu
Principal Investigator
Shanghai Chest Hospital, Shanghai, China
Suresh S Ramalingam, MD
Principal Investigator
Emory University School of Medicine, Atlanta, U.S.
Are You a Good Fit for This Trial?
This trial is for adults with stage III unresectable non-small cell lung cancer that has specific EGFR mutations and hasn't worsened after chemoradiation. Participants need a WHO performance status of 0 or 1, must use contraception if necessary, and have completed chemoradiation within the past 6 weeks. Exclusions include prior NSCLC treatments other than for stage III, inability to absorb the drug due to gastrointestinal issues, certain heart risks, uncontrolled diseases like hypertension, or severe systemic diseases.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemoradiation
Participants receive definitive platinum-based chemoradiation therapy
Treatment
Participants receive osimertinib or placebo until disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may receive open-label osimertinib after progression if they are deriving clinical benefit
What Are the Treatments Tested in This Trial?
Interventions
- Osimertinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology