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Recruiting NCT06448754

Volrustomig Priming Regimens Exploratory Phase II Platform Study

Phase II Interventional Non-small Cell Lung Cancer

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: Volrustomig, Carboplatin, Pemetrexed, Ramucirumab.
Who it may be relevant to
Registry conditions: Non-small Cell Lung Cancer. Basic parameters: 18 years — 130 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, Canada, China, France, Georgia +10
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

A Phase II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Volrustomig Priming Regimens in Combination With Other Anticancer Agents in Participants With Solid Tumors (eVOLVE-01)

Overview

Purpose of this study is to assess the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of volrustomig in combination with other anticancer drugs in participants with specified solid tumors.

Detailed description

This Phase II, platform, open-label, multicenter study will evaluate the efficacy, safety, and tolerability of volrustomig in combination with anticancer drugs in various solid tumor types.

This platform study currently includes 2 substudies:

Substudy 1: metastatic non-small cell lung cancer (mNSCLC) (non-squamous \[NSQ\]). Participants will be randomized in two treatment arms: Arm 1A and Arm 1B.

Substudy 2: mNSCLC (squamous \[SQ\] or NSQ). Participants will enroll to the Arm 2A only.

All arms will test a volrustomig dosing in combination with chemotherapy.

Interventions

  • Drug Volrustomig
    Participants will receive volrustomig via intravenous (IV) infusion.
  • Drug Carboplatin
    Participants will receive carboplatin via IV infusion.
  • Drug Pemetrexed
    Participants will receive pemetrexed via IV infusion.
  • Drug Ramucirumab
    Participants will receive ramucirumab via IV infusion.
  • Drug Paclitaxel
    Participants will receive paclitaxel via IV infusion.

Primary outcome measures

  • Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: From screening (Days -28 to Day -1) up to 2 year 10 months]
  • Confirmed Objective Response rate (ORR) [Time frame: Up to 2 year 10 months]
Secondary outcome measures (9)
  • Disease Control Rate (DCR) [Time frame: Up to 2 year 10 months]
  • Duration of Response (DOR) [Time frame: Up to 2 year 10 months]
  • Progression Free Survival (PFS) [Time frame: Up to 2 year 10 months]
  • Overall Survival (OS) [Time frame: Up to 2 year 10 months]
  • Serum Concentration of Volrustomig [Time frame: Up to 2 year 10 months]
  • Trough concentration (Ctrough) [Time frame: Up to 2 year 10 months]
  • Maximum Observed Concentration (Cmax) [Time frame: Up to 2 year 10 months]
  • Area Under the Curve (AUC) [Time frame: Up to 2 year 10 months]
  • Number of Participants with Positive Antidrug Antibodies (ADAs) [Time frame: Up to 2 year 10 months]

Eligibility criteria

Inclusion criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration.
  • Life expectancy greater than or equal to (>=) 12 weeks.
  • Adequate organ and bone marrow function.
  • Body weight greater than (>) 35 kilograms (kg) at screening and at randomization.
  • Histologically or cytologically documented NSQ NSCLC in substudy 1 and SQ or NSQ mNSCLC in substudy 2.
  • Absence of sensitizing epidermal growth factor receptor (EGFR) mutations.
  • Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L therapies.
  • At least one measurable lesion not previously irradiated that can be accurately measured at baseline as >= 10 millimeter (mm) in the longest diameter.

Exclusion criteria

  • Spinal cord compression.
  • History of primary active immunodeficiency.
  • Active or prior documented autoimmune or inflammatory disorders.
  • Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant.
  • Brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of radiation therapy and study enrollment.
  • Prior chemotherapy or any other systemic therapy for Stage IV NSCLC. Participants who have received prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for local disease are eligible, provided that progression has occurred greater (>) 12 months from end of last therapy.

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
Open label
Primary purpose
Treatment

Study locations

Spain · 10 centers
  • Research Site — A Coruña
  • Research Site — Alcorcón
  • Research Site — Barcelona
  • Research Site — Madrid
  • Research Site — Málaga
  • Research Site — Pamplona
  • Research Site — Santander
  • Research Site — Santiago de Compostela
  • … and 2 more centers
Italy · 9 centers
  • Research Site — Genoa
  • Research Site — Meldola
  • Research Site — Milan
  • Research Site — Naples
  • Research Site — Orbassano
  • Research Site — Perugia
  • Research Site — Rozzano
  • Research Site — Udine
  • … and 1 more center
United States · 7 centers
  • Research Site — Los Angeles
  • Research Site — Grand Junction
  • Research Site — Wheat Ridge
  • Research Site — Baltimore
  • Research Site — Detroit
  • Research Site — Chapel Hill
  • Research Site — Tacoma
Georgia · 6 centers
  • Research Site — Batumi
  • Research Site — Tbilisi
  • Research Site — Tbilisi
  • Research Site — Tbilisi
  • Research Site — Tbilisi
  • Research Site — Tbilisi
Portugal · 6 centers
  • Research Site — Lisbon
  • Research Site — Lisbon
  • Research Site — Lisbon
  • Research Site — Lisbon
  • Research Site — Porto
  • Research Site — Porto
China · 5 centers
  • Research Site — Beijing
  • Research Site — Hangzhou
  • Research Site — Jinan
  • Research Site — Yantai
  • Research Site — Zhengzhou
France · 5 centers
  • Research Site — Bois-Guillaume
  • Research Site — Caen
  • Research Site — Créteil
  • Research Site — Dijon
  • Research Site — Montpellier
Greece · 5 centers
  • Research Site — Athens
  • Research Site — Athens
  • Research Site — Elaiones
  • Research Site — Piraeus
  • Research Site — Thessaloniki
Switzerland · 5 centers
  • Research Site — Basel
  • Research Site — Geneva
  • Research Site — Lausanne
  • Research Site — Winterthur
  • Research Site — Zurich
Serbia · 4 centers
  • Research Site — Belgrade
  • Research Site — Belgrade
  • Research Site — Kamenitz
  • Research Site — Kragujevac
South Korea · 4 centers
  • Research Site — Seongnam
  • Research Site — Seoul
  • Research Site — Seoul
  • Research Site — Suwon
Taiwan · 4 centers
  • Research Site — Changhua
  • Research Site — New Taipei City
  • Research Site — Taipei
  • Research Site — Taipei
Malaysia · 3 centers
  • Research Site — Kuala Lumpur
  • Research Site — Kuching
  • Research Site — Perai
Romania · 3 centers
  • Research Site — Cluj-Napoca
  • Research Site — Craiova
  • Research Site — Floreşti
Canada · 1 center
  • Research Site — Montreal

Identifiers

NCT: NCT06448754 · D798KC00001 · 2023-509482-20-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗