Clinical trial NCT06448754: Volrustomig Priming Regimens Exploratory Phase II Platform Study
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Solid Tumor
Programmed cell death-ligand-1
Tumor proportion score
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-06-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 is a platform, randomized, open-label, multicenter, global study.

Enrolled participants with Stage IV non-squamous non-small cell lung cancer (NSQ NSCLC) who are treatment-naïve and have not received previous treatment for advanced or metastatic disease.

These participants will be randomized in a 1:1 ratio to one of the two treatment arms: Arm 1A and Arm 1B.

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

Eligibility criteria: Key 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.
* 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.

Key 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 advanced disease are eligible, provided that progression has occurred greater (\>) 12 months from end of last therapy.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From screening (Days -28 to Day -1) up to 2.4 years
measure: Objective Response rate (ORR)
timeFrame: Up to 2.4 years
Secondary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: Up to 2.4 years
measure: Duration of Response (DOR)
timeFrame: Up to 2.4 years
measure: Progression Free Survival (PFS)
timeFrame: Up to 2.4 years
measure: Overall Survival (OS)
timeFrame: Up to 2.4 years
measure: Serum Concentration of Volrustomig
timeFrame: Up to 2.4 years
measure: Trough concentration (Ctrough)
timeFrame: Up to 2.4 years
measure: Maximum Observed Concentration (Cmax)
timeFrame: Up to 2.4 years
measure: Area Under the Curve (AUC)
timeFrame: Up to 2.4 years
measure: Number of Participants with Positive Antidrug Antibodies (ADAs)
timeFrame: Up to 2.4 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Grand Junction
country: United States
facility: Research Site
state: Colorado
city: Wheat Ridge
country: United States
facility: Research Site
state: Colorado
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Chapel Hill
country: United States
facility: Research Site
state: North Carolina
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Beijing
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Jinan
country: China
facility: Research Site
city: Yantai
country: China
facility: Research Site
city: Zhengzhou City
country: China
facility: Research Site
city: Bois Guillaume
country: France
facility: Research Site
city: Caen Cedex
country: France
facility: Research Site
city: Créteil
country: France
facility: Research Site
city: Dijon
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Batumi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Elaiones
country: Greece
facility: Research Site
city: Peiraias
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Genoa
country: Italy
facility: Research Site
city: Meldola
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Orbassano
country: Italy
facility: Research Site
city: Perugia
country: Italy
facility: Research Site
city: Rozzano
country: Italy
facility: Research Site
city: Udine
country: Italy
facility: Research Site
city: Verona
country: Italy
facility: Research Site
city: Seongnam
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Suwon
country: Korea, Republic of
facility: Research Site
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Kuching
country: Malaysia
facility: Research Site
city: Perai
country: Malaysia
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Floresti
country: Romania
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site
city: Kragujevac
country: Serbia
facility: Research Site
city: Sremska Kamenica
country: Serbia
facility: Research Site
city: Alcorcón
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: La Coruna
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Pamplona
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
city: Santiago de Compostela
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
city: Genève 14
country: Switzerland
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
city: Winterthur
country: Switzerland
facility: Research Site
city: Zürich
country: Switzerland
facility: Research Site
city: Changhua City
country: Taiwan
facility: Research Site
city: New Taipei
country: Taiwan
facility: Research Site
city: Taipei City
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
Study officials:
References: