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Comparing Volrustomig with Pembrolizumab for Lung Cancer Treatment

A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer (mNSCLC).

Phase 3 Interventional AstraZeneca · NCT05984277

This study is testing whether a new treatment called volrustomig combined with chemotherapy works better than pembrolizumab with chemotherapy for people with advanced lung cancer that has low PD-L1 levels.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment900 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsradiation, pembrolizumab, chemotherapy
Locations289 sites (Prescott, Arizona and 288 other locations)
Trial IDNCT05984277 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness and safety of volrustomig combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC) who have low PD-L1 expression. Eligible participants will be randomly assigned to receive one of the two treatment regimens, and their tumors will be monitored for response until disease progression. The study will also track patient survival until its conclusion, with oversight from an independent data monitoring committee to ensure safety.

Who should consider this trial

Good fit: Ideal candidates are adults with stage IV metastatic non-small cell lung cancer lacking specific genetic alterations and who are not eligible for curative surgery or radiation.

Not a fit: Patients with mixed small-cell lung cancer, symptomatic brain metastases, or certain rare tumor subtypes may not benefit from this study.

Why it matters

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

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, but this specific combination is being tested for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Histologically or cytologically documented squamous or non-squamous NSCLC.
* Stage IV NSCLC (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology 2016), not amenable to curative surgery or radiation.
* Absence of sensitizing EGFR mutations and ALK and ROS1 rearrangements.
* 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 first-line therapies.

Key Exclusion Criteria:

* Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. Rare subtypes are excluded.
* Spinal cord compression.
* Symptomatic brain metastases. Brain metastases may be treated or untreated, but participants must be asymptomatic and off steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.
* History of another primary malignancy except for:

  1. Malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.
  2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  3. Adequately treated carcinoma in situ without evidence of disease.
* As judged by the investigator, any condition that would interfere with evaluation of the study intervention or interpretation of participant safety or study results.

Where this trial is running

Prescott, Arizona and 288 other locations

+239 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 Metastatic Non-small Cell Lung Cancermetastatic non-small cell lung cancernon-squamous tumorssquamous tumorsPD-L1
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.