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Chemotherapy

Osimertinib for Lung Cancer (NEOLA Trial)

Phase 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Availability of the EGFRm test results confirming that the tumour 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 including de novo T790M

Patients with histologically documented NSCLC of predominantly non-squamous, squamous, and adenosquamous pathology who present with locally advanced, unresectable (Stage III) disease (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology).

Must not have

For females only: Currently pregnant (confirmed with positive pregnancy test) or breastfeeding.

Past medical history of ILD/pneumonitis, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD/pneumonitis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed from date of first dose to progression (up to a maximum of approximately 4 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine how well osimertinib works in treating a specific type of lung cancer. It will involve patients with stage III lung cancer that cannot be surgically removed and have specific

Who is the study for?

This trial is for adults with Stage III, unresectable non-small cell lung cancer (NSCLC) that have common EGFR mutations. Participants should not have had prior treatment for this stage of cancer.

What is being tested?

The study tests the effectiveness and safety of osimertinib given before and after standard chemotherapy and radiation therapy (CRT) in treating NSCLC. Osimertinib is administered as an induction therapy followed by maintenance post-CRT.

What are the potential side effects?

Osimertinib may cause side effects like diarrhea, rash, dry skin, nail toxicity, mouth sores, decreased appetite, fatigue, coughing or shortness of breath. More serious but less common side effects include lung problems and heart rhythm changes.

Eligibility Criteria

Inclusion Criteria

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

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My tumor has EGFR mutations sensitive to certain treatments.

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My lung cancer is advanced (Stage III) and cannot be removed by surgery.

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I have a tumor that is large enough to be measured accurately.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently pregnant or breastfeeding.

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I have had lung inflammation or pneumonitis that needed steroids.

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I cannot take osimertinib due to severe nausea, vomiting, gut diseases, or major bowel surgery.

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I am allergic to certain chemotherapy drugs or their ingredients.

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I had to stop a medication because it affected my heart's rhythm.

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I am allergic to osimertinib or similar drugs.

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My lung cancer is not purely non-small cell.

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I have been treated with EGFR-TKI therapy before.

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I haven't had major surgery or serious injuries in the last 4 weeks and don't expect to need major surgery during the study.

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I have had a bone marrow transplant from another person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed from date of first dose to progression (up to a maximum of approximately 4 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed from date of first dose to progression (up to a maximum of approximately 4 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed from date of first dose to progression (up to a maximum of approximately 4 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PFS (Progression-Free Survival)

Secondary study objectives

DCR (Disease Control Rate)

EFS (Event-Free Survival)

ORR (Objective Response Rate)

+1 more

Other study objectives

AEs

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Open-Label Osimertinib Induction TreatmentExperimental Treatment3 Interventions

Patients will receive open-label osimertinib induction treatment for 8 weeks (± 1 week window to account for patient variability and CRT scheduling), followed by CRT treatment for 6 weeks (± 1 week) and then osimertinib maintenance treatment until RECIST 1.1-defined radiological progression by investigator unless there is evidence of unacceptable toxicity or if the patient requests to stop the study treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Osimertinib

2017

Completed Phase 4

~1120

Radiation

2003

Completed Phase 2

~780