Aumolertinib Versus Osimertinib As First-line Therapy for Patients with EGFR Mutated Locally Advanced or Metastatic Non-small-cell Lung Cancer

Официальное название

Aumolertinib Versus Osimertinib As First-line Therapy for Patients with EGFR Mutated Locally Advanced or Metastatic Non-small-cell Lung Cancer: a Randomized, Open-label, Non-inferiority Real World Study

Обзор

This is a multicenter, randomized, open-label, non-inferiority real world study. The study is designed to evaluate the efficacy and safety of Aumolertinib versus Osimertinib in the first-line treatment of patients with EGFR mutated locally advanced or metastatic non-small-cell lung cancer.

Подробное описание

Aumolertinib and Osimertinib are both third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) that were approved for non-small cell lung cancer (NSCLC) patients with EGFR mutation.

This study will compare the efficacy of two different EGFR-TKIs, Aumolertinib and Osimertinib, when administered as monotherapy.

This is a multicenter, randomized, open-label study with 2 different groups that are listed below.

In a randomized study, the treatment that participants receive is randomly assigned, with the assignment determined by a computer algorithm. In an "open-label" study, both the participants and the investigators are aware of the treatment allocation for each participant.

Participants will be randomly assigned to one of the following two treatment groups:

Group 1: Treatment with Aumolertinib alone, taken orally as two pills once a day. Around 158 participants will be randomly assigned to this group.

Group 2: Treatment with Osimertinib alone, taken orally as one pill once a day. Around 158 participants will be randomly assigned to this group.

Participants can continue to receive treatment as long as they have not withdrawn consent, as long as they choose to continue to receive treatment and are judged by their doctor to continue to receive clinical benefit from receiving the treatment, and as long as no other exclusion and/or discontinuation criteria are met .

Вмешательства

• Препарат Aumolertinib
  Aumolertinib will be administered orally at a dose of 110 mg per time, Q.D.
• Препарат Osimertinib
  Osimertinib will be administered orally at a dose of 80 mg per time, Q.D.

Первичные конечные точки

• Progression Free Survival (PFS) as Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Срок оценки: Up to 3 years]

Вторичные конечные точки (6)

• Overall Survival (OS) [Срок оценки: Up to 5 years]
• Objective Response Rate (ORR) as Assessed by Investigator Per RECIST v1.1 [Срок оценки: Up to 3 years]
• Disease Control Rate (DCR) as Assessed by Investigator Per RECIST v1.1 [Срок оценки: Up to 3 years]
• Duration of Response (DOR) as Assessed by Investigator Per RECIST v1.1 [Срок оценки: Up to 3 years]
• Depth of Response (DepOR) as Assessed by Investigator Per RECIST v1.1 [Срок оценки: Up to 3 years]
• Treatment-emergent adverse events (TEAEs) [Срок оценки: From first dose until 28 days after the last dose, up to 36 month]

Критерии участия

Критерии включения

• At least 18 years old.
• Participants voluntarily signed an informed consent form prior to participation.
• The Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1, no deterioration for at least 1 week before treatment, and the expected survival period is no less than 12 weeks.
• Histologically or cytologically confirmed stage IIIB-IV NSCLC (according to the AJCC eighth edition lung cancer staging criteria), metastatic or recurrent lung cancer that is not amenable to curative intent therapy.
• Positive EGFR mutation confirmed by tissue or cytology(including peripheral blood, pleural effusion, ascites, cerebrospinal fluid) with at least one sensitizing mutation (L858R or 19Del).
• No prior systemic therapy was allowed, except in the adjuvant or neoadjuvant setting, and no progression was allowed within 6 months.
• According to RECIST1.1, the patient must have at least one target lung lesion. The requirements for target lesions are: measurable lesions that have not undergone local treatment such as radiation, with the longest diameter at baseline ≥10 mm (if it is a lymph node, the maximum short diameter must be ≥15 mm).

Критерии исключения

• Diagnosis of meningeal metastasis by clinical symptoms or imaging or cerebrospinal fl-uid, or brain parenchymal metastasis combined with meningeal metastasis.
• History of other primary malignant tumors.
• Hypersensitivity or allergy to aumolertinib or osimertinib or their excipients.
• Female subjects who are pregnant, lactating, or planning to become pregnant during the treatment period.
• The investigator assesses whether there are any patients with conditions that may compromise patient safety or interfere with the evaluation of the study, such as poorly controlled hypertension, active bleeding.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital, — Пекин

Идентификаторы

NCT: NCT06752408 · K6674

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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