Comparing Volrustomig with Pembrolizumab for Lung Cancer Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Research Site
  Prescott, Arizona, United States Recruiting
• Research Site
  Hot Springs National Park, Arkansas, United States Recruiting
• Research Site
  Springdale, Arkansas, United States Recruiting
• Research Site
  Lone Tree, Colorado, United States Recruiting
• Research Site
  Fort Myers, Florida, United States Recruiting
• Research Site
  Orlando, Florida, United States Recruiting

+239 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.