Study of Osimertinib and Chemotherapy for Patients with EGFR Mutation Positive Resectable Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as Non-Small Cell Lung Cancer (NSCLC) that can be surgically removed. The study is specifically for patients whose cancer has a mutation in the Epidermal Growth Factor Receptor (EGFR), which is a protein that can affect how cancer cells grow. The trial will explore the effectiveness of a medication called Osimertinib, also known by its code name AZD9291, used alone or in combination with chemotherapy, compared to chemotherapy alone. Chemotherapy drugs used in this study include Cisplatin, Carboplatin, and Pemetrexed. A placebo, which looks like the real medication but has no active ingredients, may also be used in some cases.

The purpose of the study is to determine how well Osimertinib works as a treatment before surgery, either by itself or with chemotherapy, compared to just using chemotherapy. Participants will receive treatment over a period of time, and their response to the treatment will be monitored. The study will involve taking the medication in the form of tablets or through an intravenous infusion, which means the medication is given directly into a vein.

Throughout the study, the main focus will be on how the cancer responds to the treatment, particularly looking at the number of cancer cells remaining after treatment. Other aspects, such as the overall survival of participants and any changes in their quality of life, will also be observed. The study aims to provide valuable information on the best treatment approach for patients with this specific type of lung cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

Eligibility criteria include being at least 18 years old, having a specific type of lung cancer that can be surgically removed, and having certain genetic mutations.

2 treatment group assignment

Participants are randomly assigned to one of three treatment groups: osimertinib alone, osimertinib with chemotherapy, or chemotherapy alone.

Osimertinib is a medication taken orally, while chemotherapy involves drugs administered intravenously.

3 treatment phase

For those receiving osimertinib alone, the medication is taken as a 40 mg or 80 mg film-coated tablet daily.

Participants in the combination group receive osimertinib along with chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed, administered intravenously.

The chemotherapy alone group receives cisplatin, carboplatin, and pemetrexed intravenously.

4 surgery

After the treatment phase, surgery is performed to remove the lung cancer.

The goal is to achieve a complete surgical resection of the cancer.

5 post-surgery assessment

Following surgery, an assessment is conducted to evaluate the response to treatment.

This includes checking for any remaining cancer cells in the removed tissue.

6 follow-up

Regular follow-up visits are scheduled to monitor health and any signs of cancer recurrence.

These visits may include physical exams, imaging tests, and blood tests.

Who Can Join the Study?

  • Must be a male or female who is at least 18 years old. If under 20 years old and in Japan, written consent is needed from both the patient and a legal representative.
  • Must have a type of lung cancer called non-squamous NSCLC that can be completely removed by surgery. This is determined by a team of doctors, including a lung surgeon.
  • The cancer must be at a stage where complete surgical removal is possible, as evaluated by a team of specialists.
  • Must have an ECOG PS score of 0 or 1. This is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
  • The tumor must have specific changes in the EGFR gene, which are known to respond to certain treatments. These changes include Ex19del, L858R, and possibly others like T790M, G719X, Exon20 insertions, S7681, and L861Q.

Who Cannot Join the Study?

  • Patients who do not have a type of lung cancer called non-squamous NSCLC that can be completely removed by surgery.
  • Patients whose lung cancer is not in stages II to IIIB N2. These stages describe how much the cancer has spread.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to receive the study treatments safely.
  • Patients who are part of a vulnerable population that the study cannot safely include.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment Sofiamed OOD Sofia Bulgaria
Pius-Hospital Oldenburg Oldenburg In Holstein Germany
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Krankenhaus Nord Klinik Floridsdorf Vienna Austria
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Martha-Maria Krankenhaus Halle-Doelau gGmbH Halle (Saale) Germany
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd. Panagyurishte Bulgaria
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Polyclinique Bordeaux Nord Aquitaine Bordeaux France
Mmvxspg Uvpbemyrkv Oj Gpwb Graz Austria
Hzmcwlyk Vmwj dbkgfqwr Barcelona Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
27.03.2024
Bulgaria Bulgaria
Not recruiting
27.03.2024
France France
Not recruiting
27.03.2024
Germany Germany
Not recruiting
27.03.2024
Italy Italy
Not recruiting
27.03.2024
Poland Poland
Not recruiting
27.03.2024
Spain Spain
Not recruiting
27.03.2024

Trial locations

Osimertinib is a medication used in this trial as a treatment for patients with a specific type of lung cancer that has a mutation in the epidermal growth factor receptor (EGFR). It is being tested to see how effective it is when used alone or in combination with chemotherapy before surgery.

Chemotherapy is a standard cancer treatment that uses drugs to kill cancer cells or stop them from growing. In this trial, chemotherapy is used as a comparison to see how well it works on its own versus when combined with osimertinib for treating patients with EGFR mutation-positive lung cancer before surgery.

Investigated diseases:

Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the lung tissues, which can form tumors. NSCLC is known for its slower growth compared to small cell lung cancer, and it often spreads to other parts of the body. The disease is staged from I to IV, with Stage II to IIIB indicating more advanced local spread but not distant metastasis. Symptoms may include persistent cough, chest pain, and difficulty breathing. The progression of NSCLC can vary, with some cases remaining localized while others may spread to lymph nodes or other organs.

Trial ID:
2022-502606-33-00
Protocol code:
D516AC00001
Trial Phase:
Therapeutic confirmatory (Phase III)

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