Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC

Официальное название

Ph 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab and Nivolumab With or Without Docetaxel Versus Docetaxel in 2L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-02)

Обзор

This is an exploratory, signal-finding, randomized, placebo-controlled, blinded, multi-center phase 2b trial of the anti-GDF-15 antibody Visugromab (CTL-002) at two different dose levels plus Nivolumab with Docetaxel versus Visugromab at the higher dose plus Nivolumab with placebo versus double-placebo with Docetaxel, in participants that receive second-line treatment for non-squamous NSCLC after failure of prior first-line treatment including a CPI (checkpoint inhibitor). The trial consists of 3 Parts: an open-label Safety Run-in part (Part A) followed by a subsequent randomized phase 2b part with 4 treatment arms. After the treatment of 15 participants with visugromab at the expansion dose, an interim safety and preliminary efficacy analysis will be conducted (Part B), followed by the treatment of the remaining participants (Part C).

Вмешательства

• Биопрепарат Visugromab RDE (recommended dose for expansion)
  Participants receive Visugromab (RDE) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
• Биопрепарат Visugromab 6mg/kg
  Participants receive Visugromab (6mg/kg) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
• Биопрепарат Nivolumab
  Participants receive Nivolumab 360mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
• Другое Placebo Saline Infusion
  Participants receive Saline intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
• Препарат Docetaxel
  Participants receive Docetaxel 75 mg/m2 intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: up to 36 months]

Вторичные конечные точки (12)

• Adverse Events [Срок оценки: up to 60 months]
• CR rate [Срок оценки: up to 36 months]
• PR rate [Срок оценки: up to 36 months]
• ORR rate [Срок оценки: up to 36 months]
• DOR [Срок оценки: up to 36 months]
• TTR [Срок оценки: up to 36 months]
• PFS [Срок оценки: up to 60 months]
• OS [Срок оценки: up to 60 months]
• Participant weight course over time [Срок оценки: up to 39 months]
• Maximum Concentration (Cmax) of visugromab [Срок оценки: up to 36 months]
• Minimum Concentration (Cmin) visugromab [Срок оценки: up to 36 months]
• Participants' subjective well-being as assessed by Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) [Срок оценки: up to 39 months]

Критерии участия

Main Inclusion Criteria:

• Participants must have histologically or cytologically confirmed diagnosis of stage IV non-squamous NSCLC.
• Participants must have demonstrated absence of actionable mutations (e.g. EGFR, ALK, among others) that suggest/require treatment with available targeted agent.
• Participants must have failed one line of prior systemic treatment for metastatic NSCLC containing an approved anti PD (L)1 checkpoint inhibitor (CPI). The minimum treatment duration on this regimen must have been 12 weeks exposure for the CPI with no documented progression in this period. Failure of the prior line of systemic treatment for metastatic NSCLC must have occurred under ongoing CPI treatment. Discontinuation of the prior CPI and line of treatment due to AEs, or any other reason than progression/relapse does not permit enrollment.
• Participants must have measurable disease determined by the local site Investigator by their assessment per RECIST v1.1.
• Participants must have life expectancy of at least 3 months as assessed by the Investigator.
• Participants must have ECOG performance status ≤1.

Main Exclusion Criteria:

• Participants must not have received more than one line of prior systemic treatment for advanced/metastatic NSCLC.
• Participants must not have a prior malignancy requiring treatment.
• Participants must not have a known or detected clinically active central nervous system (CNS) involvement by NSCLC or other tumors, e.g., with symptomatic metastases and/or carcinomatous meningitis
• Participants must not have any active autoimmune disease that has required systemic treatment in past 3 months before planned treatment start (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
• Participants must not have interstitial lung disease or a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 12 центров

• University Hospital of Jaen — Jaén
• Regional University Hospital of Malaga — Málaga
• University Hospital Virgen del Rocio (HUVR) — Seville
• Hospital Clinic of Barcelona — Barcelona
• University Hospital Complex of Santiago (CHUS) — Santiago de Compostela
• University Hospital of Girona Dr. Josep Trueta — Girona
• START- Rioja — Logroño
• Clínica Universidad de Navarra — Madrid
• … и ещё 4 центра

Германия · 6 центров

• Hospital Esslingen GmbH — Esslingen am Neckar
• Thorax Clinic Heidelberg — Heidelberg
• University Hospital Wuerzburg, Clinic and Polyclinic II for Gastroenterology, Hematology, — Würzburg
• Evangelical Hospital Bethel, Clinic for Internal Medicine, Hematology/Oncology, Palliative — Bielefeld
• Clinics Essen-Mitte — Essen
• Foundation Bethanien Moers — Moers

США · 5 центров

• University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center) — Birmingham
• USC Norris Comprehensive Cancer Center — Los Angeles
• NYU Langone Hospital - Long Island — Mineola
• NYU Longone Health — New York
• Duke University Medical Center — Durham

Италия · 4 центра

• Institute of Romagna for Cancer Research "Dino Amadori" - IRCCS IRST — Forlì
• Oncology Reference Center — Aviano
• National Cancer Institute Regina Elena, IRCCS — Rome
• Local Health Unit of Romagna - Santa Maria delle Croci Hospital of Ravenna, Onco-Hematolog — Ravenna

Румыния · 3 центра

• Sf. Nectarie Oncology Center — Craiova
• Clinica Polisano S.R.L — Sibiu
• SC Oncomed SRL — Timișoara

Швейцария · 2 центра

• University Hospital Basel — Basel
• Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology — Sankt Gallen

Польша · 1 центр

• MED-Polonia, Sp. z o.o. (LLC) — Poznan

Идентификаторы

NCT: NCT07246863 · CTL-002-004 · 2024-516794-70-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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