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Study of Chemotherapy with Osimertinib in Non-Small Cell Lung Cancer Patients Who Have Progressed After Initial Osimertinib Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Non-Small Cell Lung Cancer (NSCLC) that is locally advanced or has spread to other parts of the body (metastatic). The study evaluates a combination treatment using chemotherapy drugs (cisplatin or carboplatin with pemetrexed) together with either osimertinib (also known as Tagrisso) or placebo in patients whose disease has progressed outside the brain after initial treatment with osimertinib.

The purpose of this research is to determine if adding osimertinib to chemotherapy works better than chemotherapy with placebo in treating this type of lung cancer. The study uses a double-blind design, which means neither the patient nor the doctor knows whether osimertinib or placebo is being given along with the chemotherapy.

During the study, patients receive either osimertinib tablets (40 mg or 80 mg) or matching placebo tablets by mouth, along with chemotherapy given through an intravenous line. The chemotherapy consists of either cisplatin or carboplatin combined with pemetrexed. The treatment continues until the disease worsens or other factors require stopping the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment assignment
You will be randomly assigned to one of two treatment groups. Neither you nor your doctor will know which group you are in.
Both groups will receive chemotherapy consisting of platinum drugs (carboplatin or cisplatin) plus pemetrexed given through an intravenous line.
One group will also receive osimertinib tablets (80mg), while the other group will receive placebo tablets.
Step 2
Treatment administration
You will receive chemotherapy through an intravenous line at scheduled appointments.
You will need to take either osimertinib or placebo tablets daily at home.
The treatment will continue until signs of disease progression appear or other factors require stopping.
Step 3
Regular monitoring
Your condition will be regularly assessed through medical examinations and scans.
The doctor will check for signs of disease progression both inside and outside the brain.
Your overall health status and any side effects will be monitored throughout the treatment period.
Step 4
Disease assessment
Regular scans will be performed to measure how the disease responds to treatment.
The doctor will assess if the cancer has progressed using standardized criteria (RECIST).
Both brain (intracranial) and body (extracranial) assessments will be conducted.
Step 5
Treatment continuation
Treatment will continue as long as it provides benefit and is well-tolerated.
The study will monitor your survival and disease progression throughout the treatment period.
Regular assessments will continue until the end of your participation in the study.

Who can join the trial?

11 criteria

Ability to provide signed informed consent and follow study requirements
Male participants must agree to use barrier contraception methods
Confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC)
Having advanced lung cancer (stage IIIB or IIIC) or cancer that has spread to other parts of the body (stage IVA or IVB), or recurring cancer that cannot be treated with surgery or radiation therapy
Evidence of cancer growth outside the brain after having responded to or remained stable for at least 6 months during initial osimertinib treatment, with no other treatments given afterward
Tumor must have specific genetic changes in the EGFR gene (Ex19del or L858R mutations), either alone or with other mutations including T790M
Good physical condition (WHO performance status 0 to 1) with no significant health decline in the past 2 weeks
Life expectancy greater than 12 weeks
At least one tumor that can be measured and has not been previously treated with radiation
Female participants must either:
- Use reliable birth control methods and have a negative pregnancy test before starting treatment if able to become pregnant
- Or provide evidence of being unable to become pregnant

Who cannot join the trial?

15 criteria

Prior treatment with osimertinib (a targeted cancer drug) or other similar medications
Known allergy or sensitivity to chemotherapy drugs used in this study
Active or untreated brain metastases (cancer that has spread to the brain)
Significant heart problems, including uncontrolled high blood pressure or recent heart attack
Severe liver problems or abnormal liver function tests
Pregnant or breastfeeding women
Active infection requiring systemic treatment
Other active cancers requiring treatment (except for certain skin cancers)
Major surgery within 4 weeks before starting the study
Participation in another clinical trial within 30 days
Any condition that could interfere with study procedures or evaluation
Unable to swallow oral medications
Serious psychological, family, or social issues that could affect study participation
History of certain eye problems that could be worsened by treatment
Use of medications that could interact with study drugs

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy
Universita' Degli Studi Di Verona
Responsive
Verona, Italy

Trial locations

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Investigated drugs

Osimertinib is a targeted therapy medication used to treat non-small cell lung cancer (NSCLC). It works by blocking a specific protein that helps cancer cells grow. It is taken as a tablet and specifically targets cancer cells that have certain genetic mutations in the EGFR gene. Pemetrexed is a chemotherapy medication that works by stopping cancer cells from making the substances they need to grow and multiply. It is given through an intravenous (IV) infusion and is commonly used to treat non-small cell lung cancer. Platinum-based chemotherapy (which includes medications like cisplatin or carboplatin) is a type of chemotherapy that works by damaging the DNA of cancer cells, preventing them from dividing and growing. These medications are given through an IV infusion and are often used in combination with other cancer treatments.

What is already known about the treatment

Osimertinib
An oral medication taken in tablet form that belongs to the class of targeted cancer therapies known as EGFR tyrosine kinase inhibitors. This medication works by blocking specific proteins (EGFR mutations) that promote cancer cell growth, specifically in non-small cell lung cancer (NSCLC). Currently widely used in clinical practice as a first-line treatment for EGFR-mutated NSCLC, with strong evidence supporting its efficacy in medical literature. The drug specifically targets cancer cells while having less effect on normal cells, which typically results in fewer side effects compared to traditional chemotherapy.
Pemetrexed
An intravenous chemotherapy medication that belongs to the class of antifolate antineoplastic agents. It works by interfering with the formation of DNA and RNA in cancer cells, preventing them from dividing and growing, particularly effective in non-small cell lung cancer treatment. Currently established as a standard treatment option in combination with platinum-based chemotherapy for NSCLC, supported by extensive clinical research and real-world evidence. The medication is typically administered through an IV infusion in a medical setting under careful supervision.

Investigated diseases

Non-Small Cell Lung Cancer - A type of lung cancer that develops in the cells lining the lungs' air passages and grows more slowly than small cell lung cancer. It begins when healthy cells in the lung change and grow out of control, forming a mass called a tumor. This cancer typically starts in the cells that line the airways of the lungs (bronchi) but can also begin in the smaller branches of the airways (bronchioles) or in the tiny air sacs at the end of the airways (alveoli). The disease can spread from its original location to other parts of the body through the bloodstream or lymphatic system. It accounts for approximately 85% of all lung cancers.