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 study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Medizinische Hochschule Hannover Hanover Germany
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Ospedaliera S Maria Di Terni Terni Italy
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Hospital General Universitario Morales Meseguer Murcia Spain
Azienda Ospedaliera Papardo Messina Italy
Virgen del Rocío University Hospital Sevilla Spain
Universita’ Degli Studi Di Verona Verona Italy
Hospital Universitario De Leon Leon Spain
Kliniken der Stadt Koeln gGmbH Cologne Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Servei De Salut De Les Illes Balears Palma Spain
Iyzlvkdx Czqitl Dqpebhrwfoegipawm L'hospitalet De Llobregat Spain
Udvhqoakzh Hlmbtoax Cnejsei Cologne Germany
Ihjvufmv Radyuhpyi Peb Lj Somyys Dxk Tvcsao Dbeg Afxecoj Iwno Sxmpkh Meldola Italy
Kwotiuco dhx Uiquxtsrwsxz Mkjdpawu Ajs Munich Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
25.11.2021
Italy Italy
Not recruiting
25.11.2021
Spain Spain
Not recruiting
25.11.2021

Trial locations

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.

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.

Trial ID:
2024-516330-35-00
Protocol code:
D5162C00042
NCT ID:
NCT04765059
Trial Phase:
Therapeutic confirmatory (Phase III)

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