Study to Evaluate Adverse Events, Optimal Dose, and Change in Disease Activity, With Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus IV Infused Pembrolizumab Plus Chemotherapy in Adult Participants With Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Официальное название

A Randomized, Phase 2/3 Study to Evaluate the Optimal Dose, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Обзор

Non-Squamous Non-Small Cell Lung Cancer (NSCLC) remains a leading cause of cancer mortality worldwide, with poor survival prospects for metastatic disease. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab plus chemotherapy versus pembrolizumab plus chemotherapy in participants with untreated metastatic non-squamous non-small cell lung cancer. Livmoniplimab is an investigational drug being developed for the treatment of NSCLC. There are 2 stages to this study. In Stage 1, there are 4 treatment arms. Participants will either receive livmoniplimab (at different doses) in combination with budigalimab (another investigational drug) + chemotherapy, budigalimab +chemotherapy, or pembrolizumab +chemotherapy. In Stage 2, there are 2 treatments arms. Participants will either receive livmoniplimab (optimized dose) in combination with budigalimab +chemotherapy or placebo in combination with pembrolizumab +chemotherapy. Chemotherapy consists of IV Infused pemetrexed + IV infused cisplatin or IV infused or injected carboplatin. Approximately 840 adult participants will be enrolled in the study across 200 sites worldwide. Stage 1: In cohort 1, participants will receive intravenously (IV) infused livmoniplimab (dose A)+ IV infused budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + IV Infused pemetrexed. In cohort 2, participants will receive livmoniplimab (dose B) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. In cohort 3, participants will receive budigalimab + chemotherapy for 4 cycles followed by budigalimab + pemetrexed . In cohort 4, participants will receive IV Infused pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. Stage 2: In arm 1, participants will receive livmoniplimab (dose optimized) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. In arm 2, participants will receive IV Infused placebo + pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. The estimated study duration is 55 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.

Вмешательства

• Препарат Livmoniplimab
  Intravenously (IV) Infusion
• Препарат Budigalimab
  IV Infusion
• Препарат Pembrolizumab
  IV Infusion
• Препарат Pemetrexed
  IV Infusion
• Препарат Cisplatin
  IV Infusion
• Препарат Carboplatin
  IV Injection
• Препарат Carboplatin
  IV Infusion

Первичные конечные точки

• Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR) [Срок оценки: Up to 21 Months]
• Stage 2: Overall Survival (OS) [Срок оценки: Up to 55 Months]

Вторичные конечные точки (12)

• Stage 1: Progression Free Survival (PFS) [Срок оценки: Up to 21 Months]
• Stage 1: Duration of Response (DOR) [Срок оценки: Up to 21 Months]
• Stage 1: OS [Срок оценки: Up to 21 Months]
• Stage 2: PFS [Срок оценки: Up to 55 Months]
• Stage 2: BOR of CR/PR [Срок оценки: Up to 55 Months]
• Stage 2: Change from Baseline in Physical Functioning (PF) as measured by the PF domain of European Organization for Research Treatment of Cancer Quality of Life Questionnaire 17 (EORTC QLQ-F17) [Срок оценки: Up to 55 Months]
• Stage 2: Change from Baseline in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) [Срок оценки: Up to 55 Months]
• Stage 2: Change from Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-F17 [Срок оценки: Up to 55 Months]
• Stage 2: PFS per Investigator [Срок оценки: Up to 55 Months]
• Stage 1: BOR of CR/PR per Investigator [Срок оценки: Up to 21 Months]
• Stage 2: DOR [Срок оценки: Up to 55 Months]
• Stage 2: DOR per investigator [Срок оценки: Up to 55 Months]

Критерии участия

Критерии включения

• Diagnosis of histologically or cytologically confirmed metastatic nonsquamous non-small cell lung cancer (NSCLC) with no known epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) mutation, or other genomic aberration for which a locally approved targeted therapy is available.
• Must have at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) v1.1 as determined by the local site Investigator/radiology assessment.
• Life expectancy of at least 3 months and adequate organ function.

Критерии исключения

\- Received prior systemic therapy for the treatment of metastatic NSCLC.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 19 центров

• Moores Cancer Center /ID# 267782 — La Jolla
• Memorial Hospital West /ID# 262221 — Pembroke Pines
• Bond Clinic /ID# 262611 — Winter Haven
• University Cancer & Blood Cent /ID# 261824 — Athens
• The University of Chicago Medical Center /ID# 262259 — Chicago
• University of Kansas Medical Center /ID# 263196 — Westwood
• Baptist Health Lexington /ID# 261823 — Lexington
• Cancer & Hematology Centers of Western Michigan - East /ID# 261826 — Grand Rapids
• … и ещё 11 центров

Испания · 7 центров

• Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 262723 — Santiago de Compostela
• Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 262118 — L'Hospitalet de Llobregat
• UOMi Cancer Center - Clinica Tres Torres /ID# 262116 — Barcelona
• Hospital Universitario Vall de Hebron /ID# 262113 — Barcelona
• Hospital General Universitario Gregorio Maranon /ID# 262114 — Madrid
• Hospital Universitario 12 de Octubre /ID# 262112 — Madrid
• Hospital Clinico Universitario de Valencia /ID# 262115 — Valencia

Бельгия · 6 центров

• Universitair Ziekenhuis Antwerpen /ID# 261270 — Edegem
• Cliniques Universitaires UCL Saint-Luc /ID# 261267 — Brussels
• Hospital La Louviere Site Jolimont - Helora /ID# 261269 — La Louvière
• Groupe Sante CHC - Clinique du MontLegia /ID# 262338 — Liège
• AZ Maria Middelares /ID# 262313 — Ghent
• UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 262557 — Namur

Чили · 5 центров

• Centro de Investigacion y Desarrollo Oncologico /ID# 261800 — Temuco
• Oncored /Id# 261801 — Vitacura
• Fundacion Arturo Lopez Perez /ID# 261700 — Providencia
• Sociedad Cem-Cancer Spa /Id# 262316 — Viña del Mar
• Hospital Clinico Universidad De Los Andes /ID# 262665 — Santiago

Франция · 5 центров

• APHM - Hopital Nord /ID# 261129 — Marseille
• CHU Grenoble - Hopital Michallon /ID# 261131 — La Tronche
• Institut Curie /ID# 261127 — Paris
• Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 261644 — Bron
• Centre Hosp Intercommunal de Creteil /ID# 261130 — Créteil

Тайвань · 4 центра

• National Cheng Kung University Hospital /ID# 262016 — Tainan
• Mackay Memorial Hospital /ID# 262534 — Taipei
• Taipei Medical University Hospital /ID# 262020 — Taipei
• Linkou Chang Gung Memorial Hospital /ID# 262535 — Taoyuan City

Австралия · 3 центра

• Canberra Hospital /ID# 261891 — Garran
• Nepean Hospital /ID# 262157 — Kingswood
• Westmead Hospital /ID# 261894 — Westmead

Япония · 3 центра

• National Cancer Center Hospital East /ID# 261923 — Kashiwa-shi
• Saitama Prefectural Cancer Center /ID# 262703 — Kitaadachi-gun
• National Cancer Center Hospital /ID# 261925 — Chuo-ku

Нидерланды · 3 центра

• Ziekenhuis St. Jansdal /ID# 261193 — Harderwijk
• Zuyderland Medisch Centrum /ID# 261190 — Heerlen
• Isala /ID# 262458 — Zwolle

Turkey (Türkiye) · 3 центра

• Gazi University Medical Faculty /ID# 261786 — Ankara
• Ankara City Hospital /ID# 261785 — Ankara
• Dr. Suat Seren Gogus Has /ID# 261789 — Izmir

Израиль · 2 центра

• Shaare Zedek Medical Center /ID# 262432 — Jerusalem
• Rambam Health Care Campus /ID# 262431 — Haifa

Пуэрто-Рико · 1 центр

• Pan American Center for Oncology Trials /ID# 269666 — Rio Piedras

Идентификаторы

NCT: NCT06236438 · M23-721 · 2023-505773-32-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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