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Exploring a new treatment for advanced non-small cell lung cancer

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)

Phase 2 Interventional AstraZeneca · NCT06448754

This study is testing a new treatment combining volrustomig and chemotherapy for people with advanced non-small cell lung cancer who haven't had treatment before, to see how well it works and how safe it is.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations77 sites (Los Angeles, California and 76 other locations)
Trial IDNCT06448754 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of volrustomig combined with chemotherapy in patients with Stage IV non-squamous non-small cell lung cancer who have not received prior treatment. Participants will be randomly assigned to one of two treatment groups to assess the drug's pharmacokinetics, immunogenicity, and antitumor activity. The study is multicenter and global, aiming to gather comprehensive data on the treatment's performance across diverse populations.

Who should consider this trial

Good fit: Ideal candidates are treatment-naïve adults with Stage IV non-squamous non-small cell lung cancer and adequate organ function.

Not a fit: Patients with spinal cord compression or those with active autoimmune disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced non-small cell lung cancer.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, indicating potential for success in this novel combination.

Eligibility criteria

Show full inclusion / exclusion 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 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.

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

Where this trial is running

Los Angeles, California and 76 other locations

+27 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-small Cell Lung CancerSolid TumorProgrammed cell death-ligand-1Tumor proportion score
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.