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RecruitingLast updated: 6 February 2024

eVOLVE-Lung02: This study is testing how safe and effective immunotherapy is when given in combination with chemotherapy as first-line treatment in people with metastatic non-small cell lung cancerA 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).

Clinical summary

Summary

Eligible participants will be randomly allocated to one of two treatment arms. 

In Arm 1 (Experimental), participants will receive volrustomig immunotherapy plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via intravenous (IV) infusion.

In Arm 2 (Active Comparator), participants will receive pembrolizumab immunotherapy plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via IV infusion.

Conditions

This trial is treating patients with metastatic non-small cell lung cancer

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

III

Trial Acronym

eVOLVE-Lung02

More information

Trial Identifiers

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Trial sponsor

AstraZeneca

Scientific Title

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).

Eligibility

Inclusion

  • 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.

Exclusion

  • Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. Rare subtypes are excluded.
  • Spinal cord compression.
  • 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 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.

Inclusion

  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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