Study Comparing Chemotherapy Plus Osimertinib to Chemotherapy Plus Placebo in Patients with Non-Small Cell Lung Cancer (NSCLC)
Sponsor: AstraZeneca
ClinicalTrials ID:NCT04765059
This clinical trial is testing whether adding the drug osimertinib to chemotherapy is more effective than chemotherapy with a placebo in patients with non-small cell lung cancer (NSCLC) that has worsened outside the brain after initial osimertinib treatment.
Patient Parameters
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Program Overview
The study aims to find out if combining chemotherapy with osimertinib is better at controlling non-small cell lung cancer (NSCLC) than chemotherapy with a placebo. This is for patients whose cancer has spread outside the brain after responding to osimertinib as their first treatment. About 80 patients will participate, receiving either chemotherapy with osimertinib or chemotherapy with a placebo. The study will also look at the presence of brain metastases to see if it affects treatment outcomes.
Description
This study involves two groups of patients with advanced non-small cell lung cancer (NSCLC) that has specific genetic mutations making them sensitive to certain treatments. Patients will be randomly assigned to one of two treatment groups:
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Treatment Arm A: Patients will receive osimertinib daily along with chemotherapy drugs pemetrexed and either cisplatin or carboplatin for four cycles. After that, they will continue with osimertinib and pemetrexed as maintenance therapy.
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Treatment Arm B: Patients will receive a placebo daily along with the same chemotherapy drugs for four cycles, followed by placebo and pemetrexed as maintenance therapy.
The study will compare the effectiveness of these treatments in controlling cancer that has progressed outside the brain after initial osimertinib therapy.
Eligibility Criteria
Inclusion Criteria
- Able to provide informed consent and follow study requirements.
- Diagnosed with non-squamous NSCLC that is advanced or has spread and cannot be treated with surgery or radiotherapy.
- Cancer has worsened outside the brain after at least 6 months of initial osimertinib treatment.
- Tumor has specific EGFR mutations sensitive to treatment.
- Good overall health with a performance status of 0 or 1.
- Life expectancy of more than 12 weeks.
- At least one measurable tumor that has not been treated with radiation.
- Women must use effective birth control and have a negative pregnancy test if they can become pregnant.
- Men must agree to use barrier contraception.
Exclusion Criteria
- Cancer has worsened in the brain during first-line osimertinib treatment.
- History of lung diseases like interstitial lung disease or pneumonitis.
- Severe or uncontrolled systemic diseases.
- Heart conditions that could affect treatment safety.
- Other active cancers needing treatment within the last 2 years.
- Unresolved side effects from previous treatments.
- Digestive issues that affect drug absorption.
- More than 4 weeks since the last dose of osimertinib.
- Unable to tolerate osimertinib at the standard dose.
- Previous systemic anti-cancer therapy.
- Major surgery within 4 weeks before starting the study.
- Recent extensive radiotherapy.
- Use of certain medications or supplements that affect drug metabolism.
- Participation in another clinical study with investigational drugs recently.
Locations
| FACILITY | ZIP | CITY | STATE |
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| Research Site | 20910 | Silver Spring | Maryland |
| Research Site | 02114 | Boston | Massachusetts |
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