search
Back to results

A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer. (eVOLVE-Lung02)

Primary Purpose

Metastatic Non-small Cell Lung Cancer

Status
Not yet recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Volrustomig
Pembrolizumab
Carboplatin
Paclitaxel
Pemetrexed
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Non-small Cell Lung Cancer focused on measuring metastatic non-small cell lung cancer, non-squamous tumors, squamous tumors, PD-L1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. 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: 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. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. 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.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Volrustomig plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion

Pembrolizumab plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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).
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.
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.
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.
Concentration of volrustomig in serum and PK parameters
To assess the PK of volrustomig
Presence of ADAs against volrustomig in serum
To investigate the immunogenicity of volrustomig.
Time-To-Deterioration (TTD) in physical functioning
To assess participant-reported physical functioning in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy.
TTD of lung cancer symptoms
To assess participant-reported pulmonary symptoms of mNSCLC in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy.

Full Information

First Posted
August 2, 2023
Last Updated
August 2, 2023
Sponsor
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT05984277
Brief Title
A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.
Acronym
eVOLVE-Lung02
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).
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 30, 2023 (Anticipated)
Primary Completion Date
May 30, 2028 (Anticipated)
Study Completion Date
May 16, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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%.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Non-small Cell Lung Cancer
Keywords
metastatic non-small cell lung cancer, non-squamous tumors, squamous tumors, PD-L1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
None (Open Label)
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Volrustomig plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Pembrolizumab plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
Intervention Type
Drug
Intervention Name(s)
Volrustomig
Intervention Description
Volrustomig
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Pembrolizumab
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) (using BICR assessments according to RECIST 1.1)
Description
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.
Time Frame
Up to approximately 6 years
Title
Overall Survival (OS), in PD-L1-negative participants.
Description
OS is defined as the time from randomization until the date of death due to any cause, in PD-L1-negative participants.
Time Frame
Up to approximately 6 years
Secondary Outcome Measure Information:
Title
PFS (using BICR assessments according to RECIST 1.1)
Description
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.
Time Frame
Up to approximately 6 years
Title
OS
Description
OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants.
Time Frame
Up to approximately 6 years
Title
PFS (using Investigator assessments according to RECIST 1.1)
Description
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).
Time Frame
Up to approximately 6 years
Title
Overall Response Rate (ORR)
Description
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.
Time Frame
Up to approximately 6 years
Title
Duration of Response (DoR)
Description
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.
Time Frame
Up to approximately 6 years
Title
PFS2
Description
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.
Time Frame
Up to approximately 6 years
Title
Concentration of volrustomig in serum and PK parameters
Description
To assess the PK of volrustomig
Time Frame
Up to approximately 6 years
Title
Presence of ADAs against volrustomig in serum
Description
To investigate the immunogenicity of volrustomig.
Time Frame
Up to approximately 6 years
Title
Time-To-Deterioration (TTD) in physical functioning
Description
To assess participant-reported physical functioning in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy.
Time Frame
Up to approximately 6 years
Title
TTD of lung cancer symptoms
Description
To assess participant-reported pulmonary symptoms of mNSCLC in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy.
Time Frame
Up to approximately 6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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: 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. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Facility Information:
Facility Name
Research Site
City
Rosario
ZIP/Postal Code
S2000DEJ
Country
Argentina
Facility Name
Research Site
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Research Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Research Site
City
Lévis
State/Province
Quebec
ZIP/Postal Code
G6V 0B8
Country
Canada
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
611135
Country
China
Facility Name
Research Site
City
Bergamo
ZIP/Postal Code
24125
Country
Italy
Facility Name
Research Site
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Research Site
City
Parma
ZIP/Postal Code
43126
Country
Italy
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Research Site
City
Kashiwa
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Research Site
City
Koto-ku
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Research Site
City
Osakasayama-shi
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Research Site
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Research Site
City
Jinju-si
ZIP/Postal Code
52727
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Research Site
City
Suwon
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Research Site
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
Facility Name
Research Site
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Research Site
City
Tilburg
ZIP/Postal Code
5042AD
Country
Netherlands
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Research Site
City
Przemysl
ZIP/Postal Code
37-700
Country
Poland
Facility Name
Research Site
City
Rzeszów
ZIP/Postal Code
35-241
Country
Poland
Facility Name
Research Site
City
Szklarska Poręba
ZIP/Postal Code
58-580
Country
Poland
Facility Name
Research Site
City
Tomaszów Mazowiecki
ZIP/Postal Code
97-200
Country
Poland
Facility Name
Research Site
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
01-138
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
90-549
Country
Poland
Facility Name
Research Site
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Research Site
City
Bilbao (Vizcaya)
ZIP/Postal Code
48013
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Málaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Research Site
City
Palma
ZIP/Postal Code
07198
Country
Spain
Facility Name
Research Site
City
Taipei City
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Research Site
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Research Site
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
Research Site
City
Bury St Edmunds
ZIP/Postal Code
IP332QZ
Country
United Kingdom
Facility Name
Research Site
City
Colchester
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
Research Site
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. SignedData Sharing Agreement (non-negotiable contract for data accessors) must be inplace before accessing requested information. Additionally, all users will need toaccept the terms and conditions of the SAS MSE to gain access. For additionaldetails, please review the Disclosure Statements athttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home

Learn more about this trial

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

We'll reach out to this number within 24 hrs