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

PHASE3RECRUITING

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%.

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Study details:

Adult patients with a histologically or cytologically documented metastatic NSCLC, with tumors that lack activating EGFR, ALK, and ROS1 alterations are eligible for enrollment. Patients will be randomized in a 1:1 ratio to receive treatment with volrustomig + chemotherapy or pembrolizumab + chemotherapy. Tumor evaluation scans will be performed until disease progression as efficacy assessment.

All patients will be followed for survival until the end of the study. An data monitoring committee (DMC) composed of independent experts will be convened to confirm the safety and tolerability of the proposed dose and schedule.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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:

As judged by the investigator, any condition that would interfere with evaluation of the study intervention or interpretation of participant safety or study results.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-10-24

Primary completion: 2028-05-30

Study completion finish: 2029-05-16

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT05984277

Intervention or treatment

DRUG: Volrustomig

DRUG: Pembrolizumab

DRUG: Carboplatin

DRUG: Paclitaxel

DRUG: Pemetrexed

Conditions

• Metastatic Non-small Cell Lung Cancer

Image related to Metastatic Non-small Cell Lung Cancer

Condition: Metastatic Non-small Cell Lung Cancer
DRUG: Volrustomig and other drugs
Clayton, Not Specified, Australia and more
Sponsor: AstraZeneca

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Research Site

Research sites nearby

Select from list below to view details:

Research Site
Clayton, Not Specified, Australia
Research Site
Heidelberg, Not Specified, Australia
Research Site
South Brisbane, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm 1 Volrustomig plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion	DRUG: Volrustomig Volrustomig
ACTIVE_COMPARATOR: Arm 2 Pembrolizumab plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion	DRUG: Pembrolizumab Pembrolizumab

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Progression-Free Survival (PFS) (using BICR assessments according to RECIST 1.1)	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.	Up to approximately 6 years
Overall Survival (OS), in PD-L1-negative participants.	OS is defined as the time from randomization until the date of death due to any cause, in PD-L1-negative participants.	Up to approximately 6 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
PFS (using BICR assessments according to RECIST 1.1)	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.	Up to approximately 6 years
OS	OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants.	Up to approximately 6 years
PFS (using Investigator assessments according to RECIST 1.1)	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).	Up to approximately 6 years
Overall Response Rate (ORR)	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.	Up to approximately 6 years
Duration of Response (DoR)	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.	Up to approximately 6 years
PFS2	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.	Up to approximately 6 years
Concentration of volrustomig in serum and PK parameters	To assess the PK of volrustomig	Up to approximately 6 years
Presence of ADAs against volrustomig in serum	To investigate the immunogenicity of volrustomig.	Up to approximately 6 years
Time-To-Deterioration (TTD) in physical functioning	To assess participant-reported physical functioning in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy.	Up to approximately 6 years
TTD of lung cancer symptoms	To assess participant-reported pulmonary symptoms of mNSCLC in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy.	Up to approximately 6 years

Frequently Asked Questions

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References

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