Trial of Local Consolidation Therapy (LCT) After Osimertinib for Patients With EGFR Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC)

Titre officiel

Randomized Phase II Trial of Local Consolidation Therapy (LCT) After Osimertinib for Patients With EGFR Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC)

Sommaire:

L’objectif de cette recherche est de découvrir si la réception d’un traitement de consolidation local (LCT – intervention chirurgicale, radiothérapie ou une combinaison des deux) après l’administration d’osimertinib peut aider à contrôler le cancer du poumon non à petites cellules (CPNPC) par rapport à un traitement continu par osimertinib seulement. L’innocuité de ce traitement sera également examinée. Il s’agit d’une étude expérimentale. L’osimertinib est approuvé par la Food and Drug Administration (FDA) et disponible sur le marché pour le traitement du CPNPC. Une intervention chirurgicale ou la radiothérapie, après l’administration d’osimertinib à des patients atteints d’un CPNPC, sont considérées comme des procédures expérimentales. Jusqu’à 143 participants seront recrutés pour cette étude multicentrique. Jusqu’à 143 patients peuvent y prendre part au centre anticancéreux MD Anderson.

Description de l'essai

Primary Outcome:

• Progression-Free Survival (PFS)

Secondary Outcome:

• Time to Appearance of New Metastases (TANM)
• Progression of Target Lesions
• Progression of Non-Target Lesions
• Adverse Events of Osimertinib with and without LCT
• Overall survival (OS)
• Determination Whether Osimertinib plus LCT Improves Progression-Free Survival Compared with Osimertinib Alone in the Subgroup of Patients with Oligometastatic NSCLC (up to3 metastases)
• Determination Whether Osimertinib plus LCT Improves Overall Survival (OS) Compared with Osimertinib Alone
• Determination if There is a Difference in Survival Outcomes or Toxicity by Radiation Treatment Modality (protons vs. photons)

Study Groups and Study Drug Administration: If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. This is done because no one knows if one group is better, the same, or worse than the other.

• Group 1 will receive LCT after treatment with osimertinib. The study doctor will decide if you will have radiation alone, surgery alone, or radiation combined with surgery. However, if the doctor thinks it is in your best interest, you may be able to continue taking osimertinib in addition to LCT.

• Group 2 will not receive LCT after osimertinib. Instead, you will continue treatment with osimertinib. All participants will take osimertinib by mouth every day for about 6-12 weeks as part of your standard care. This is called Induction Therapy. Group 1: Depending on what the study doctor thinks is in your best interest, you will receive surgery, radiation, or both after you complete Induction Therapy.

• If you have surgery, you will be given a separate consent form to sign that describes the surgical procedure and its risks in more detail. The type of surgery you will have will depend on the status of the disease and what the doctor thinks is in your best interest. If you are also receiving osimertinib, you will need to stop taking it for about 7 days before surgery.

• If you have radiation therapy, about 1-2 weeks before you begin radiation therapy, you will have a procedure called a simulation. During the simulation, the exact location for the radiation therapy will be planned. The simulation procedure takes about 1 hour. You will receive radiation every day for 5 days in a row(Monday through Friday) up to 8 weeks, depending on the location and status of the disease. The radiation only takes a few minutes to administer each day. However, you should expect to stay in the clinic for 1 hour each day. You will be given a separate consent form to sign that describes the radiation therapy and its risks in more detail. The type of radiation therapy you will have will depend on the status of the disease. If you have both radiation therapy and surgery, the study doctor will tell you which you will have first. Group 2: You will continue to take osimertinib by mouth every day. Length of Treatment : You may continue receiving osimertinib or as long as the doctor thinks it is in your best interest. If you are in Group 1, you may receive surgery one (1) time and/or radiation therapy for up to 8 weeks. You will no longer be able to receive the study treatment if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your participation on the study will be over after the follow-up visits. Study Visits: About every 4 weeks during Induction Therapy:

• You will have a physical exam.

• Blood (about 2 teaspoons) will be drawn for routine tests.

• You will have an EKG. About every 8 weeks:

• You will have a physical exam.Blood (about 2 teaspoons) will be drawn for routine tests.

• You will have an EKG. Every 6 weeks during Induction Therapy and then every 8 weeks after that, you will have a CT or PET/CT scan to check the status of the disease. Every 3 months, you will have an ECHO or MUGA scan. Follow-Up Visits: Within 30 days after study treatment:

• You will have a physical exam.

• Blood (about 2 teaspoons) will be drawn for routine tests.

• You will have an EKG. Long-Term Follow-Up: Every 6 months, you will be asked how you are doing and if you have had any side effects. This may be done by collecting information from your medical record or the study staff may call you. If you are called, this call should last about 5-10 minutes. If you stopped the study treatment for reasons other than the disease getting worse, you will continue to have CT or PET/CT scans as described above. If the disease get worse, you will stop having these scans; although the study doctor may ask you to have another CT or PET/CT scan as part of your standard care if needed.

Voir cet essai sur ClinicalTrials.gov