A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC)

Официальное название

A Phase III, Randomized, Open-label Study Evaluating the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Patients With Resected Stage II-III KRAS G12C-Positive Non-small Cell Lung Cancer

Обзор

The main purpose of this study is to evaluate the efficacy of divarasib compared with investigator's choice of immunotherapy (pembrolizumab or nivolumab) or observation in participants with resected Kirsten rat sarcoma viral oncogene homolog glycine 12 to cysteine (KRAS G12C)-positive Stage II-IIIB NSCLC, regardless of tumor programmed death-ligand 1 (PD-L1) status, who have not achieved pathologic complete response (pCR) following neoadjuvant chemoimmunotherapy.

Вмешательства

• Препарат Divarasib
  Divarasib will be administered orally as per the schedule specified in the respective arm.
• Препарат Pembrolizumab
  Pembrolizumab will be administered as either a 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) or 395 mg subcutaneous (SC) injection Q3W, for up to 13 cycles (1 cycle = 21 days).
• Препарат Nivolumab
  Nivolumab will be administered as either a 480 mg IV infusion, every 4 weeks (Q4W) or 1200 mg SC injection Q4W, for up to 13 cycles (1 cycle = 28 days).

Первичные конечные точки

• Disease-free Survival (DFS), as Determined by the Investigator [Срок оценки: From randomization to disease recurrence or death from any cause (Up to approximately 5 years)]

Вторичные конечные точки (3)

• Overall Survival (OS) [Срок оценки: From date of randomization to death from any cause (up to approximately 8 years)]
• DFS Rates at 2 and 3 Years, as Assessed by the Investigator [Срок оценки: At Year 2 and Year 3]
• Number of Participants With Adverse Events (AEs) [Срок оценки: From randomization to 60 days after the end of study treatment (up to approximately 8 years)]

Критерии участия

Критерии включения

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Histological or cytological diagnosis of clinical Stage II-IIIB NSCLC of either non-squamous or squamous histology
• Participants must have had complete resection of NSCLC
• Prior treatment with neoadjuvant immune checkpoint inhibitor (pembrolizumab or nivolumab) in combination with histology-based platinum-based doublet chemotherapy
• Participants must be randomized within 12 weeks of their surgery date
• No evidence of disease recurrence or metastatic disease
• Documentation of the presence of a KRAS G12C mutation

Критерии исключения

• Participants who achieve pCR following neoadjuvant treatment
• Prior treatment with a KRAS inhibitor or any other anti-cancer therapy not otherwise specified in the protocol
• Prior treatment with radiation therapy for NSCLC, with the exception of localized symptom-directed radiation prior to surgical resection
• Resolved Grade 3 or greater immune-related AE or unresolved Grade 2 or greater immune-related AE from neoadjuvant immunotherapy
• Active or history of autoimmune disease or immune deficiency
• Significant cardiovascular disease

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07541170 · BO45885 · 2025-524263-21-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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