A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC

Официальное название

A Phase 2 Study Evaluating the Safety and Efficacy of Neoadjuvant Amivantamab in Combination With Lazertinib or Chemotherapy in Resectable EGFR-Mutated Non-Small Cell Lung Cancer

Обзор

The purpose of this study is to assess the ability to slow down or stop the growth of cancer with amivantamab combined with either lazertinib or chemotherapy (carboplatin and pemetrexed) in participants with resectable, epidermal growth factor receptor (EGFR) mutated, Stage II-IIIB non-small cell lung cancer (NSCLC). NSCLC is the most common type of lung cancer. NSCLC may occur due to mutations (changes) in many genes, including EGFR.

Вмешательства

• Препарат Amivantamab
  Amivantamab will be administered.
• Препарат Lazertinib
  Lazertinib will be administered.
• Препарат Carboplatin
  Carboplatin will be administered.
• Препарат Pemetrexed
  Pemetrexed will be administered.

Первичные конечные точки

• Major Pathologic response (MPR) [Срок оценки: Up to 1 year 8 months]

Вторичные конечные точки (5)

• Pathological Complete Response (pCR) [Срок оценки: Up to 1 year 8 months]
• Number of Participants with Pathologic Nodal Downstaging at the Time of Surgery [Срок оценки: Baseline and up to 1 year 8 months]
• Disease Control Rate (DCR) [Срок оценки: Up to 1 year 8 months]
• Number of Participants with Adverse Events (AEs) by Severity [Срок оценки: Up to 1 year 8 months]
• Number of Participants with Abnormalities in Clinical Laboratory Parameters [Срок оценки: Up to 1 year 8 months]

Критерии участия

Критерии включения

• Participant must have histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) with completely resectable Stage II-IIIB N2 disease
• Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a multidisciplinary team evaluation
• Participant must consent to a screening biopsy, if clinically feasible, if no adequate tumor tissue is available for a baseline sample
• Participant may have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s). Prior or concurrent second malignancies must be reviewed and agreed to with the medical monitor
• Have an eastern cooperative oncology group (ECOG) performance status of 0 or 1

Критерии исключения

• History of uncontrolled illness
• Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current interstitial lung disease (ILD)/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
• Suspected or known allergies, hypersensitivity, or intolerance to excipients of: the combination of amivantamab and lazertinib or carboplatin and pemetrexed
• Presence of primary driver mutations (anaplastic lymphoma kinase \[ALK\], mesenchymal-epithelial transition \[MET\], human epidermal growth factor receptor 2 \[HER2\], proto-oncogene tyrosine-protein kinase ROS \[ROS1\], neurotrophic tyrosine receptor kinase \[NTRK\], B-Raf proto-oncogene \[BRAF\], REarranged during transfection \[RET\], or kirsten rat sarcoma viral oncogene homolog \[KRAS\]) , besides EGFR Exon 19del or Exon 21 L858R mutations, as determined by local genomic testing
• Prior treatment with any systemic anti-cancer therapy for NSCLC including EGFR-tyrosine kinase inhibitor (TKI) therapy, chemotherapy, biologic therapy, immunotherapy, or any investigational drug

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• West China Hospital Sichuan University — Чэнду
• Guangdong Provincial People's Hospital — Гуанчжоу

Испания · 2 центра

• Hosp. Gral. Univ. Dr. Balmis — Alicante
• Hosp. Gral. Univ. Gregorio Maranon — Madrid

Тайвань · 2 центра

• Chi Mei Medical Center Liouying Branch — Tainan
• Taipei Medical University Hospital — Taipei

Канада · 1 центр

• Princess Margaret Hospital — Toronto

South Korea · 1 центр

• Samsung Medical Center — Seoul

Идентификаторы

NCT: NCT07586202 · 61186372PANSC2005 · 61186372PANSC2005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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