Clinical trial NCT05984277: A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.
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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Metastatic Non-small Cell Lung Cancer
Keywords: metastatic non-small cell lung cancer
non-squamous tumors
squamous tumors
PD-L1
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-08-09
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.
* 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.

Primary outcomes:
measure: Progression-Free Survival (PFS) (using BICR assessments according to RECIST 1.1)
timeFrame: Up to approximately 6 years
measure: Overall Survival (OS), in PD-L1-negative participants.
timeFrame: Up to approximately 6 years
Secondary outcomes:
measure: PFS (using BICR assessments according to RECIST 1.1)
timeFrame: Up to approximately 6 years
measure: OS
timeFrame: Up to approximately 6 years
measure: PFS (using Investigator assessments according to RECIST 1.1)
timeFrame: Up to approximately 6 years
measure: Overall Response Rate (ORR)
timeFrame: Up to approximately 6 years
measure: Duration of Response (DoR)
timeFrame: Up to approximately 6 years
measure: PFS2
timeFrame: Up to approximately 6 years
measure: Concentration of volrustomig in serum and PK parameters
timeFrame: Up to approximately 6 years
measure: Presence of ADAs against volrustomig in serum
timeFrame: Up to approximately 6 years
measure: Time-To-Deterioration (TTD) in physical functioning
timeFrame: Up to approximately 6 years
measure: TTD of lung cancer symptoms
timeFrame: Up to approximately 6 years
Other outcomes:
Locations:
city: Prescott
country: United States
facility: Research Site
state: Arizona
city: Hot Springs National Park
country: United States
facility: Research Site
state: Arkansas
city: Springdale
country: United States
facility: Research Site
state: Arkansas
city: Palo Alto
country: United States
facility: Research Site
state: California
city: Lone Tree
country: United States
facility: Research Site
state: Colorado
city: Newark
country: United States
facility: Research Site
state: Delaware
city: Fort Myers
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Saint Petersburg
country: United States
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state: Florida
city: Tallahassee
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state: Florida
city: West Palm Beach
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state: Florida
city: Indianapolis
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state: Indiana
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city: Baton Rouge
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state: Louisiana
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city: Annapolis
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state: Maryland
city: Baltimore
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state: Maryland
city: Baltimore
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state: Maryland
city: Silver Spring
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state: Maryland
city: Towson
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state: Maryland
city: Detroit
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state: Michigan
city: Hattiesburg
country: United States
facility: Research Site
state: Mississippi
city: Grand Island
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facility: Research Site
state: Nebraska
city: Lincoln
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facility: Research Site
state: Nebraska
city: Omaha
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state: Nebraska
city: Belleville
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state: New Jersey
city: Albany
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state: New York
city: East Syracuse
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state: New York
city: Fresh Meadows
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state: New York
city: Westbury
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state: New York
city: Cleveland
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state: Ohio
city: Columbus
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state: Ohio
city: Columbus
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state: Ohio
city: Dayton
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city: Portland
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state: Oregon
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state: Pennsylvania
city: Pittsburgh
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state: Pennsylvania
city: Memphis
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state: Tennessee
city: Nashville
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state: Tennessee
city: Nashville
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state: Tennessee
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state: Texas
city: Irving
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state: Texas
city: Lancaster
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state: Virginia
city: Henrico
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state: Virginia
city: Tacoma
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facility: Research Site
state: Washington
city: Buenos Aires
country: Argentina
facility: Research Site
city: Caba
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facility: Research Site
city: Caba
country: Argentina
facility: Research Site
city: Caba
country: Argentina
facility: Research Site
city: Ciudad de Córdoba
country: Argentina
facility: Research Site
city: Córdoba
country: Argentina
facility: Research Site
city: La Plata
country: Argentina
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city: La Plata
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: Clayton
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facility: Research Site
city: Fitzroy
country: Australia
facility: Research Site
city: Heidelberg
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facility: Research Site
city: South Brisbane
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facility: Research Site
city: Sydney
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facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Wels
country: Austria
facility: Research Site
city: Aalst
country: Belgium
facility: Research Site
city: Antwerpen
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Barretos
country: Brazil
facility: Research Site
city: Curitiba
country: Brazil
facility: Research Site
city: Florianópolis
country: Brazil
facility: Research Site
city: Fortaleza
country: Brazil
facility: Research Site
city: Natal
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Rio De Janeiro
country: Brazil
facility: Research Site
city: Santa Cruz do Sul
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Barrie
country: Canada
facility: Research Site
state: Ontario
city: Oshawa
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Levis
country: Canada
facility: Research Site
state: Quebec
city: Trois-Rivières
country: Canada
facility: Research Site
state: Quebec
city: Chicoutimi
country: Canada
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Bengbu
country: China
facility: Research Site
city: Changchun
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Fuzhou
country: China
facility: Research Site
city: Guangzhou
country: China
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city: Hangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hefei
country: China
facility: Research Site
city: Lanzhou
country: China
facility: Research Site
city: Linhai
country: China
facility: Research Site
city: Linyi
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Nanning
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenzhen
country: China
facility: Research Site
city: Taiyuan
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Xi'an
country: China
facility: Research Site
city: Yangzhou
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
city: Olomouc
country: Czechia
facility: Research Site
city: Ostrava - Vitkovice
country: Czechia
facility: Research Site
city: Praha 2
country: Czechia
facility: Research Site
city: Praha
country: Czechia
facility: Research Site
city: Angers
country: France
facility: Research Site
city: Avignon
country: France
facility: Research Site
city: Bayonne
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Caen
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Limoges
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Paris Cedex 5
country: France
facility: Research Site
city: Quimper
country: France
facility: Research Site
city: Reims
country: France
facility: Research Site
city: Saint-Malo
country: France
facility: Research Site
city: Strasbourg Cedex
country: France
facility: Research Site
city: Suresnes
country: France
facility: Research Site
city: Toulon Naval
country: France
facility: Research Site
city: Berlin-Zehlendorf
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Braunschweig
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Gauting
country: Germany
facility: Research Site
city: Georgsmarienhuette
country: Germany
facility: Research Site
city: Gütersloh
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Immenhausen
country: Germany
facility: Research Site
city: Koblenz
country: Germany
facility: Research Site
city: Ludwigsburg
country: Germany
facility: Research Site
city: Nürnberg
country: Germany
facility: Research Site
city: Tuebingen
country: Germany
facility: Research Site
city: Velbert
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Deszk
country: Hungary
facility: Research Site
city: Gyöngyös - Mátraháza
country: Hungary
facility: Research Site
city: Gyöngyös
country: Hungary
facility: Research Site
city: Győr
country: Hungary
facility: Research Site
city: Kecskemét
country: Hungary
facility: Research Site
city: Pécs
country: Hungary
facility: Research Site
city: Szekszárd
country: Hungary
facility: Research Site
city: Székesfehérvár
country: Hungary
facility: Research Site
city: Törökbálint
country: Hungary
facility: Research Site
city: Bengaluru
country: India
facility: Research Site
city: Delhi
country: India
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
city: Kolkata
country: India
facility: Research Site
city: Kolkata
country: India
facility: Research Site
city: Mysuru
country: India
facility: Research Site
city: Nagpur
country: India
facility: Research Site
city: Nashik
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: Varanasi
country: India
facility: Research Site
city: Bari
country: Italy
facility: Research Site
city: Bergamo
country: Italy
facility: Research Site
city: Catanzaro
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Parma
country: Italy
facility: Research Site
city: Pavia
country: Italy
facility: Research Site
city: Ravenna
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Bunkyo-ku
country: Japan
facility: Research Site
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Kashiwa
country: Japan
facility: Research Site
city: Kawasaki-shi
country: Japan
facility: Research Site
city: Koto-ku
country: Japan
facility: Research Site
city: Matsuyama-shi
country: Japan
facility: Research Site
city: Nagoya-shi
country: Japan
facility: Research Site
city: Okayama-shi
country: Japan
facility: Research Site
city: Osaka-shi
country: Japan
facility: Research Site
city: Osakasayama-shi
country: Japan
facility: Research Site
city: Sagamihara-shi
country: Japan
facility: Research Site
city: Sapporo-Shi
country: Japan
facility: Research Site
city: Sendai-shi
country: Japan
facility: Research Site
city: Ube-shi
country: Japan
facility: Research Site
city: Yokohama-shi
country: Japan
facility: Research Site
city: Cheongju-si
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Jinju-si
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Suwon-si
country: Korea, Republic of
facility: Research Site
city: Suwon
country: Korea, Republic of
facility: Research Site
city: Ciudad de México
country: Mexico
facility: Research Site
city: Ciudad de México
country: Mexico
facility: Research Site
city: Culiacan
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Mexico City
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Naucalpan
country: Mexico
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Nieuwegein
country: Netherlands
facility: Research Site
city: Tilburg
country: Netherlands
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Olsztyn
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Przemysl
country: Poland
facility: Research Site
city: Radom
country: Poland
facility: Research Site
city: Rzeszów
country: Poland
facility: Research Site
city: Szklarska Poręba
country: Poland
facility: Research Site
city: Tomaszów Mazowiecki
country: Poland
facility: Research Site
city: Toruń
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Banska Bystrica
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Trnava
country: Slovakia
facility: Research Site
city: Amanzimtoti
country: South Africa
facility: Research Site
city: Bloemfontein
country: South Africa
facility: Research Site
city: George
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Pietermaritzburg
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Rondebosch
country: South Africa
facility: Research Site
city: Soweto
country: South Africa
facility: Research Site
city: Alicante
country: Spain
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city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Bilbao (Vizcaya)
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Palma
country: Spain
facility: Research Site
city: Hsinchu
country: Taiwan
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city: Kaohsiung
country: Taiwan
facility: Research Site
city: New Taipei
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei City
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taoyuan
country: Taiwan
facility: Research Site
city: Yunlin
country: Taiwan
facility: Research Site
city: Lampang
country: Thailand
facility: Research Site
city: Muang
country: Thailand
facility: Research Site
city: Songkhla
country: Thailand
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Antalya
country: Turkey
facility: Research Site
city: Diyarbakir
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: İzmir
country: Turkey
facility: Research Site
city: Pamukkale
country: Turkey
facility: Research Site
city: Çankaya
country: Turkey
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Blackpool
country: United Kingdom
facility: Research Site
city: Bury St Edmunds
country: United Kingdom
facility: Research Site
city: Colchester
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Truro
country: United Kingdom
facility: Research Site
Study officials:
References: