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Osimertinib After Chemoradiation for Lung Cancer (LAURA Trial)

Phase 3

Waitlist Available

Led By Shun Lu, MD

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The tumor harbours one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations

Patients must have received either concurrent chemoradiation or sequential chemoradiation including at least 2 cycles of platinum based chemotherapy and a total dose of radiation of 60 Gy ±10% (54 to 66 Gy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 45 months

Awards & highlights

LAURA Trial Summary

This trial looks at giving a new cancer drug, osimertinib, to people with a certain kind of lung cancer that has spread and cannot be removed by surgery.

Who is the study for?

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.Check my eligibility

What is being tested?

The LAURA study tests the effectiveness and safety of Osimertinib following chemoradiation therapy compared to a placebo in patients with a particular mutation-positive lung cancer. It's designed to see if this treatment can improve outcomes for these patients after initial therapy.See study design

What are the potential side effects?

Osimertinib may cause side effects such as diarrhea, rashes, dry skin, nail changes, mouth sores; less commonly it can affect the lungs causing breathlessness or coughing (signs of possible lung inflammation), heart rhythm abnormalities (QTc prolongation), and could potentially interact with other drugs.

LAURA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor has a specific EGFR mutation known to respond to certain treatments.

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I've had chemoradiation for cancer, including platinum-based chemo and specific radiation doses.

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My cancer did not worsen after receiving platinum-based chemoradiation.

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I am fully active or able to carry out light work.

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My lung cancer is advanced but cannot be removed with surgery.

LAURA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 45 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 45 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 45 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS)

Secondary outcome measures

Disease control rate (DCR)

Duration of response (DoR)

Incidence of Adverse Events (AEs)

+13 more

LAURA Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: OsimertinibExperimental Treatment1 Intervention

Osimertinib (80mg or 40mg orally, once daily), in accordance with the randomization schedule.

Group II: Placebo OsimertinibPlacebo Group1 Intervention

Matching placebo for Osimertinib (80mg or 40mg orally, once daily), in accordance with the randomization schedule

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,262 Previous Clinical Trials

288,595,026 Total Patients Enrolled

Shun Lu, MDPrincipal InvestigatorShanghai Chest Hospital, Shanghai, China

13 Previous Clinical Trials

2,918 Total Patients Enrolled

Suresh S Ramalingam, MDPrincipal InvestigatorEmory University School of Medicine, Atlanta, U.S.

Media Library

Non-Small Cell Lung Cancer Research Study Groups: Placebo Osimertinib, Osimertinib

Non-Small Cell Lung Cancer Clinical Trial 2023: Osimertinib 80mg/40mg Highlights & Side Effects. Trial Name: NCT03521154 — Phase 3

Osimertinib 80mg/40mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT03521154 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who does this trial prefer as participants?

"This study is currently enrolling 216 individuals that have a diagnosis of lung cancer and are between 18-130 years old."

Answered by AI

Are the age requirements for this clinical trial flexible?

"This particular clinical trial is only available to patients that fall between 18-130 years of age. If you are either under or over this age bracket, there are 45 and 2057 trials respectively that may be more suited for you."

Answered by AI

Can you tell me if there is any precedence for this dosage of Osimertinib?

"Osimertinib 80mg/40mg is being actively researched in 105 clinical trials, with 17 of them currently in Phase 3. Even though several Uniondale, New york locations are conducting trials for Osimertinib 80mg/40mg, there are a total of 4724 sites where research is taking place."

Answered by AI

Does the FDA consider Osimertinib 80mg/40mg an effective medication?

"Osimertinib 80mg/40mg falls in Phase 3 of clinical trials, so there is some evidence of its efficacy and it has undergone multiple rounds of testing for safety. Therefore, we believe that it is a safe medication."

Answered by AI

In how many different therapeutic centers is this research being conducted today?

"There are 5 sites where this trial is being conducted, with the closest locations to Atlanta, Florham Park and Salt Lake City. It's crucial that patients pick a location near to them as to not have extra strain from travelling."

Answered by AI

Are we currently accepting participants for this trial?

"Although this study is not currently looking for participants, it's worth noting that it was last edited on 10/20/2022. Additionally, there are 1960 and 105 studies respectively recruiting patients with lung cancer and those taking Osimertinib 80mg/40mg."

Answered by AI

Has a study like this been done before?

"Osimertinib 80mg/40mg has been under investigation since 2013 when the first clinical trial was sponsored by AstraZeneca. Following this Phase 1 & 2 study, which had 603 participants, it received drug approval and today there are 105 live studies involving Osimertinib 80mg/40mg taking place in 1061 cities and 51 different nations."

Answered by AI

How many people have been recruited for this research project?

"Unfortunately, this particular clinical trial is not currently enrolling patients. Although, it was last updated on 10/20/2022, the study is not presently looking for new participants. On the bright side, there are 1960 other trials for lung cancer and 105 trials involving Osimertinib 80mg/40mg that are actively recruiting patients right now."

Answered by AI

Recent research and studies

Clinical Lung CancerJournal

Osimertinib Maintenance After Definitive Chemoradiation in Patients with Unresectable EGFR Mutation Positive Stage III Non–small-cell Lung Cancer: LAURA Trial in Progress

Lu, Shun, Ignacio Casarini, Terufumi Kato, Manuel Cobo, Mustafa Özgüroğlu, Rachel Hodge, Toon van der Gronde, Matilde Saggese, and Suresh S. Ramalingam. 2021. “Osimertinib Maintenance After Definitive Chemoradiation in Patients with Unresectable EGFR Mutation Positive Stage III Non–small-cell Lung Cancer: LAURA Trial in Progress”. Clinical Lung Cancer. Elsevier BV. doi:10.1016/j.cllc.2020.11.004.

clinicaltrials.govStudy

A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA)

2018. "A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03521154.

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