Volrustomig Priming Regimens Exploratory Phase II Platform Study

Description

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.

Conditions

Non-small Cell Lung Cancer

Study Overview

Study Details

Study 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.

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)

Volrustomig Priming Regimens Exploratory Phase II Platform Study

Condition
Non-small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Research Site, Los Angeles, California, United States, 90067

Grand Junction

Research Site, Grand Junction, Colorado, United States, 81501

Wheat Ridge

Research Site, Wheat Ridge, Colorado, United States, 80033

Baltimore

Research Site, Baltimore, Maryland, United States, 21231

Detroit

Research Site, Detroit, Michigan, United States, 48202

Chapel Hill

Research Site, Chapel Hill, North Carolina, United States, 27514

Tacoma

Research Site, Tacoma, Washington, United States, 98405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 130 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2026-12-08