A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.

NCT05984277
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Participants
895
clinicaltrials.gov
Lead sponsor
AstraZeneca
clinicaltrials.gov
Start date
2023-10-24
clinicaltrials.gov
Number of sites
231
clinicaltrials.gov

Summary
The purpose of eVOLVE-Lung02 is to test the effectiveness (efficacy) and measure the safety of volrustomig in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy as 1L treatment in participants with mNSCLC in PD-L1 \< 50%.
clinicaltrials.gov
Acronym
eVOLVE-Lung02
clinicaltrials.gov
Short title
A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.
clinicaltrials.gov
Official 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).
clinicaltrials.gov

Control arm
Active comparator
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2027-11-12
clinicaltrials.gov
First posted
2023-08-09
clinicaltrials.gov
Registry last updated
2026-10-09
clinicaltrials.gov
Primary completion date
2026-08-17
clinicaltrials.gov
Start date
2023-10-24
clinicaltrials.gov

Actual participants
895
clinicaltrials.gov
Participants
895
clinicaltrials.gov
Participant count basis
Actual
clinicaltrials.gov
Protocol amendments
3
clinicaltrials.gov
Randomisation ratio
1:1
clinicaltrials.gov
Number of sites
231
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
AstraZeneca
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05984277
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05984277
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Masking description
None (Open Label)
Sources for study design
clinicaltrials.gov

  1. Progression-Free Survival (PFS) (using BICR assessments according to RECIST 1.1)

    Timeframe: Up to approximately 6 years

    PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression), in PD-L1-negative participants.

  2. Overall Survival (OS), in PD-L1-negative participants.

    Timeframe: Up to approximately 6 years

    OS is defined as the time from randomization until the date of death due to any cause, in PD-L1-negative participants.

  1. PFS (using BICR assessments according to RECIST 1.1)

    Timeframe: Up to approximately 6 years

    PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). The analysis will include all randomized participants.

  2. OS

    Timeframe: Up to approximately 6 years

    OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants.

  3. PFS (using Investigator assessments according to RECIST 1.1)

    Timeframe: Up to approximately 6 years

    PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by investigator, or death due to any cause (in the absence of progression).

  4. Overall Response Rate (ORR)

    Timeframe: Up to approximately 6 years

    ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by BICR assessments using RECIST 1.1.

  5. Duration of Response (DoR)

    Timeframe: Up to approximately 6 years

    DoR is defined as the time from the date of first documented response until the date of documented progression per BICR assessments using RECIST 1.1 or death due to any cause (in the absence of progression). These analyses will include participants who have a confirmed response.

  6. PFS2

    Timeframe: Up to approximately 6 years

    PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial investigator-assessed progression) after the start of the first subsequent therapy, or death. The date of second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice.

  7. Concentration of volrustomig in serum and PK parameters

    Timeframe: Up to approximately 6 years

    To assess the PK of volrustomig

  8. Presence of ADAs against volrustomig in serum

    Timeframe: Up to approximately 6 years

    To investigate the immunogenicity of volrustomig.

  9. Time-To-Deterioration (TTD) in physical functioning

    Timeframe: Up to approximately 6 years

    To assess participant-reported physical functioning in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy.

  10. TTD of lung cancer symptoms

    Timeframe: Up to approximately 6 years

    To assess participant-reported pulmonary symptoms of mNSCLC in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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 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.

Sources for eligibility
clinicaltrials.gov

  • Research SiteHot Springs, United States
  • Research SiteSpringdale, United States
  • Research SiteLong Beach, United States
  • Research SiteLone Tree, United States
  • Research SiteOrlando, United States
  • Research SiteSt. Petersburg, United States
  • Research SiteIndianapolis, United States
  • Research SiteDes Moines, United States
  • Research SiteBaltimore, United States
  • Research SiteTowson, United States
  • Research SiteDetroit, United States
  • Research SiteGrand Island, United States
  • Research SiteLincoln, United States
  • Research SiteOmaha, United States
  • Research SiteEast Syracuse, United States
  • Research SiteColumbus, United States
  • Research SitePortland, United States
  • Research SiteHorsham, United States
  • Research SitePittsburgh, United States
  • Research SiteMemphis, United States
  • Research SiteNashville, United States
  • Research SiteNashville, United States
  • Research SiteHouston, United States
  • Research SiteIrving, United States
  • Research SiteFairfax, United States

And 206 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-000056-38
Sources for references
clinicaltrials.gov

Related records

Drugs (5)

Lead sponsors (1)

Conditions (1)

Targets (20)