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Recruiting NCT07246863

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

Phase II Interventional Metastatic Non-Squamous Non-Small Cell Lung Cancer Adult Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Visugromab RDE (recommended dose for expansion), Visugromab 6mg/kg, Nivolumab, Placebo Saline Infusion.
Who it may be relevant to
Registry conditions: Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adult Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Germany, Italy, Poland, Romania +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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).

Interventions

  • Biological 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)
  • Biological Visugromab 6mg/kg
    Participants receive Visugromab (6mg/kg) intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
  • Biological Nivolumab
    Participants receive Nivolumab 360mg intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
  • Other Placebo Saline Infusion
    Participants receive Saline intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)
  • Drug Docetaxel
    Participants receive Docetaxel 75 mg/m2 intravenous (IV) on Day 1 of every 21-day cycle (every 3 weeks, or Q3W)

Primary outcome measures

  • Objective Response Rate (ORR) [Time frame: up to 36 months]
Secondary outcome measures (12)
  • Adverse Events [Time frame: up to 60 months]
  • CR rate [Time frame: up to 36 months]
  • PR rate [Time frame: up to 36 months]
  • ORR rate [Time frame: up to 36 months]
  • DOR [Time frame: up to 36 months]
  • TTR [Time frame: up to 36 months]
  • PFS [Time frame: up to 60 months]
  • OS [Time frame: up to 60 months]
  • Participant weight course over time [Time frame: up to 39 months]
  • Maximum Concentration (Cmax) of visugromab [Time frame: up to 36 months]
  • Minimum Concentration (Cmin) visugromab [Time frame: up to 36 months]
  • Participants' subjective well-being as assessed by Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) [Time frame: up to 39 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Spain · 12 centers
  • 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
  • … and 4 more centers
Germany · 6 centers
  • 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
United States · 5 centers
  • 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
Italy · 4 centers
  • 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
Romania · 3 centers
  • Sf. Nectarie Oncology Center — Craiova
  • Clinica Polisano S.R.L — Sibiu
  • SC Oncomed SRL — Timișoara
Switzerland · 2 centers
  • University Hospital Basel — Basel
  • Cantonal Hospital Saint Gallen, Clinic of Oncology and Hematology — Sankt Gallen
Poland · 1 center
  • MED-Polonia, Sp. z o.o. (LLC) — Poznan

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗