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

Metastatic Non-small Cell Lung Cancer Clinical Trial

— 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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05984277
• Other study ID #: D798AC00001
• Secondary ID: 2023-000056-38
• Status: Recruiting
• Phase: Phase 3
• Start date: October 24, 2023
• Est. completion date: May 16, 2029

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: May 16, 2029
• Est. primary completion date: May 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Non-small Cell Lung Cancer

Intervention

Drug:
• Volrustomig
Volrustomig
• Pembrolizumab
Pembrolizumab
• Carboplatin
Carboplatin
• Paclitaxel
Paclitaxel
• Pemetrexed
Pemetrexed

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Caba
Argentina	Research Site	Caba
Argentina	Research Site	Caba
Argentina	Research Site	Ciudad de Córdoba
Argentina	Research Site	Córdoba
Argentina	Research Site	La Plata
Argentina	Research Site	La Plata
Argentina	Research Site	Rosario
Australia	Research Site	Clayton
Australia	Research Site	Fitzroy
Australia	Research Site	Heidelberg
Australia	Research Site	South Brisbane
Australia	Research Site	Sydney
Austria	Research Site	Linz
Austria	Research Site	Wels
Belgium	Research Site	Aalst
Belgium	Research Site	Antwerpen
Belgium	Research Site	Gent
Brazil	Research Site	Barretos
Brazil	Research Site	Curitiba
Brazil	Research Site	Florianópolis
Brazil	Research Site	Fortaleza
Brazil	Research Site	Natal
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Rio De Janeiro
Brazil	Research Site	Santa Cruz do Sul
Brazil	Research Site	Sao Paulo
Canada	Research Site	Barrie	Ontario
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Chicoutimi
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Levis	Quebec
Canada	Research Site	Oshawa	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Trois-Rivières	Quebec
Canada	Research Site	Winnipeg	Manitoba
China	Research Site	Chengdu
China	Research Site	Chengdu
Czechia	Research Site	Olomouc
Czechia	Research Site	Ostrava - Vitkovice
Czechia	Research Site	Praha
Czechia	Research Site	Praha 2
France	Research Site	Angers
France	Research Site	Avignon
France	Research Site	Bayonne
France	Research Site	Bordeaux
France	Research Site	Caen
France	Research Site	Lille
France	Research Site	Limoges
France	Research Site	Marseille
France	Research Site	Montpellier
France	Research Site	Paris Cedex 5
France	Research Site	Quimper cedex
France	Research Site	Reims
France	Research Site	Saint-Malo
France	Research Site	Strasbourg Cedex
France	Research Site	Suresnes
Germany	Research Site	Berlin-Zehlendorf
Germany	Research Site	Bonn
Germany	Research Site	Dresden
Germany	Research Site	Essen
Germany	Research Site	Gauting
Germany	Research Site	Georgsmarienhuette
Germany	Research Site	Halle
Germany	Research Site	Hamburg
Germany	Research Site	Heidelberg
Germany	Research Site	Immenhausen
Germany	Research Site	Koblenz
Germany	Research Site	Nürnberg
Germany	Research Site	Tuebingen
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Gyöngyös - Mátraháza
Hungary	Research Site	Gyor
Hungary	Research Site	Pécs
Hungary	Research Site	Székesfehérvár
Hungary	Research Site	Szekszárd
Hungary	Research Site	Törökbálint
India	Research Site	Bengaluru
India	Research Site	Delhi
India	Research Site	Hyderabad
India	Research Site	Kolkata
India	Research Site	Kolkata
India	Research Site	Mysuru
India	Research Site	Nagpur
India	Research Site	Nashik
India	Research Site	New Delhi
India	Research Site	Varanasi
Italy	Research Site	Bari
Italy	Research Site	Bergamo
Italy	Research Site	Catanzaro
Italy	Research Site	Milano
Italy	Research Site	Padova
Italy	Research Site	Parma
Italy	Research Site	Pavia
Italy	Research Site	Ravenna
Italy	Research Site	Roma
Italy	Research Site	Roma
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Kashiwa
Japan	Research Site	Kawasaki-shi
Japan	Research Site	Nagoya-shi
Japan	Research Site	Osakasayama-shi
Japan	Research Site	Yokohama-shi
Korea, Republic of	Research Site	Cheongju-si
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Jinju-si
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon
Korea, Republic of	Research Site	Suwon-si
Mexico	Research Site	Ciudad de México
Mexico	Research Site	Ciudad de México
Mexico	Research Site	Culiacan
Mexico	Research Site	Guadalajara
Mexico	Research Site	Guadalajara
Mexico	Research Site	Mexico City
Mexico	Research Site	Monterrey
Mexico	Research Site	Naucalpan
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Groningen
Netherlands	Research Site	Nieuwegein
Netherlands	Research Site	Tilburg
Poland	Research Site	Lódz
Poland	Research Site	Lublin
Poland	Research Site	Poznan
Poland	Research Site	Przemysl
Poland	Research Site	Rzeszów
Poland	Research Site	Szklarska Poreba
Poland	Research Site	Tomaszów Mazowiecki
Poland	Research Site	Torun
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Slovakia	Research Site	Banska Bystrica
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Kosice
Slovakia	Research Site	Trnava
South Africa	Research Site	Amanzimtoti
South Africa	Research Site	Bloemfontein
South Africa	Research Site	George
South Africa	Research Site	Johannesburg
South Africa	Research Site	Parktown
South Africa	Research Site	Pietermaritzburg
South Africa	Research Site	Pretoria
South Africa	Research Site	Rondebosch
South Africa	Research Site	Soweto
Spain	Research Site	Alicante
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Bilbao (Vizcaya)
Spain	Research Site	Madrid
Spain	Research Site	Málaga
Spain	Research Site	Palma
Taiwan	Research Site	Hsinchu
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Tainan
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei City
Taiwan	Research Site	Yunlin
Thailand	Research Site	Lampang
Thailand	Research Site	Muang
Thailand	Research Site	Songkhla
Turkey	Research Site	Ankara
Turkey	Research Site	Antalya
Turkey	Research Site	Çankaya
Turkey	Research Site	Diyarbakir
Turkey	Research Site	Istanbul
Turkey	Research Site	Izmir
Turkey	Research Site	Pamukkale
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Blackpool
United Kingdom	Research Site	Bury St Edmunds
United Kingdom	Research Site	Colchester
United Kingdom	Research Site	London
United Kingdom	Research Site	London
United Kingdom	Research Site	London
United Kingdom	Research Site	London
United Kingdom	Research Site	Truro
United States	Research Site	Albany	New York
United States	Research Site	Annapolis	Maryland
United States	Research Site	Baltimore	Maryland
United States	Research Site	Baltimore	Maryland
United States	Research Site	Baton Rouge	Louisiana
United States	Research Site	Belleville	New Jersey
United States	Research Site	Cleveland	Ohio
United States	Research Site	Columbus	Ohio
United States	Research Site	Columbus	Ohio
United States	Research Site	Dayton	Ohio
United States	Research Site	Denver	Colorado
United States	Research Site	Denver	Colorado
United States	Research Site	Des Moines	Iowa
United States	Research Site	Detroit	Michigan
United States	Research Site	East Syracuse	New York
United States	Research Site	Fairfax	Virginia
United States	Research Site	Fort Myers	Florida
United States	Research Site	Fresh Meadows	New York
United States	Research Site	Grand Island	Nebraska
United States	Research Site	Hattiesburg	Mississippi
United States	Research Site	Henrico	Virginia
United States	Research Site	Hot Springs National Park	Arkansas
United States	Research Site	Houston	Texas
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Lancaster	Texas
United States	Research Site	Louisville	Kentucky
United States	Research Site	Marrero	Louisiana
United States	Research Site	Memphis	Tennessee
United States	Research Site	Nashville	Tennessee
United States	Research Site	Nashville	Tennessee
United States	Research Site	Newark	Delaware
United States	Research Site	Omaha	Nebraska
United States	Research Site	Orlando	Florida
United States	Research Site	Palo Alto	California
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Portland	Oregon
United States	Research Site	Prescott	Arizona
United States	Research Site	Saint Petersburg	Florida
United States	Research Site	Silver Spring	Maryland
United States	Research Site	Springdale	Arkansas
United States	Research Site	Tacoma	Washington
United States	Research Site	Tallahassee	Florida
United States	Research Site	Towson	Maryland
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Westbury	New York

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  France,  Germany,  Hungary,  India,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Slovakia,  South Africa,  Spain,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Concentration of volrustomig in serum and PK parameters	To assess the PK of volrustomig	Up to approximately 6 years
Secondary	Presence of ADAs against volrustomig in serum	To investigate the immunogenicity of volrustomig.	Up to approximately 6 years
Secondary	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
Secondary	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

External Links

•   CTIS structured data update