A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer

Официальное название

A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Olomorasib Combination Therapy in Metastatic Non-small Cell Lung Cancer

Обзор

The main purpose of this study is to find out the most suitable dose (recommended phase 2 combination dose \[RP2CD\]) of amivantamab and olomorasib combination therapy and to assess how well the combination slows down or prevents the growth of tumors in participants with KRAS G12C mutant metastatic non-small cell lung cancer (NSCLC: the most common type of lung cancer; metastatic: has spread to other parts of the body; KRAS G12C mutant: mutation \[change\] in the kirsten rat sarcoma viral oncogene homolog \[KRAS\] gene in tumor cells in which glycine \[G\] at position 12 is replaced with cystine \[C\]).

Вмешательства

• Препарат Amivantamab
  Amivantamab will be administered.
• Препарат Olomorasib
  Olomorasib will be administered.

Первичные конечные точки

• Phase 1: Number of Participants with Adverse Events (AEs) by Severity [Срок оценки: Up to approximately 3 years 2 months]
• Phase 1: Number of Participants with Dose-Limiting Toxicities (DLTs) [Срок оценки: Up to approximately 3 years 2 months]
• Phase 2: Confirmed Objective Response Rate (ORR) [Срок оценки: Up to approximately 3 years 2 months]

Вторичные конечные точки (6)

• Number of Participants with Adverse Events (AEs) by Severity [Срок оценки: Up to approximately 3 years 2 months]
• Number of Participants with Abnormalities in Clinical Laboratory Parameters [Срок оценки: Up to approximately 3 years 2 months]
• Phase 2: Duration of Response (DoR) [Срок оценки: Up to approximately 3 years 2 months]
• Phase 2: Disease Control Rate (DCR) [Срок оценки: Up to approximately 3 years 2 months]
• Phase 2: Progression-Free Survival (PFS) [Срок оценки: Up to approximately 3 years 2 months]
• Phase 2: Overall Survival (OS) [Срок оценки: Up to approximately 3 years 2 months]

Критерии участия

Критерии включения

• Participant must have histologically or cytologically confirmed metastatic NSCLC characterized by a KRAS G12C mutation at the time of enrollment. For Phase 1: Participant must have progressed on or after, or have intolerance to, platinum-based chemotherapy and Programmed Death-Ligand 1 (PD-L1)-targeted immunotherapy given in combination or sequentially. Receipt of additional lines of prior therapy is permitted. Progression must have occurred on or after the most recent line of systemic anticancer therapy. For Phase 2: Participant must have progressed on or after platinum-based chemotherapy and PD-L1-targeted immunotherapy given in combination or sequentially. Progression must have occurred on or after the most recent line of systemic anticancer therapy. Receipt of additional lines of prior therapy is not permitted
• Participant must have at least 1 measurable lesion, according to RECIST version.1.1, that has not been previously irradiated
• May have brain metastases only if previously definitively, locally treated, and participant is clinically stable and asymptomatic for greater than (>) 2 weeks and is off or receiving low-dose corticosteroid treatment for at least 2 weeks prior to start of study treatment
• Can have a prior or concurrent second malignancy (other than the disease under study) with natural history or treatment course that is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Критерии исключения

• Participant has history of uncontrolled illness
• Suspected or known allergies, hypersensitivity, or intolerance to amivantamab excipients or olomorasib excipients
• Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
• Presence of primary driver mutations (epidermal growth factor receptor \[EGFR\], anaplastic lymphoma kinase \[ALK\], mesenchymal-epithelial transition \[MET\], human epidermal growth factor receptor 2 \[HER2\], ROS1, neurotrophic tyrosine receptor kinase \[NTRK\], B-Raf proto-oncogene \[BRAF\], rearranged during Transfection \[RET\], neuroblastoma RAS viral oncogene homolog \[NRAS\], and other KRAS mutations besides G12C) as determined by local genomic testing
• Prior treatment with any KRAS inhibitor

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• New York University Langone Medical Center — New York
• Oncology Consultants Cancer Center — Houston
• Virginia Cancer Specialists — Fairfax

Китай · 3 центра

• The First Affiliated Hospital Sun Yat sen University — Гуанчжоу
• Harbin medical university cancer hospital — Харбин
• Shanghai East Hospital — Шанхай

South Korea · 3 центра

• Severance Hospital Yonsei University Health System — Seoul
• Asan Medical Center — Seoul
• Samsung Medical Center — Seoul

Turkey (Türkiye) · 3 центра

• Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Mer — Ankara
• Ankara Bilkent Sehir Hastanesi — Çankaya
• Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi — Istanbul

Канада · 1 центр

• Princess Margaret Hospital — Toronto

Идентификаторы

NCT: NCT07227025 · 61186372PANSC2004 · 61186372PANSC2004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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