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

NCT ID: NCT05984277

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-24

Study Completion Date

2029-03-23

Brief Summary

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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

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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.

Conditions

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Metastatic Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

None (Open Label)

Study Groups

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Arm 1

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

Group Type EXPERIMENTAL

Volrustomig

Intervention Type DRUG

Volrustomig

Carboplatin

Intervention Type DRUG

Carboplatin

Paclitaxel

Intervention Type DRUG

Paclitaxel

Pemetrexed

Intervention Type DRUG

Pemetrexed

Arm 2

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

Group Type ACTIVE_COMPARATOR

Pembrolizumab

Intervention Type DRUG

Pembrolizumab

Carboplatin

Intervention Type DRUG

Carboplatin

Paclitaxel

Intervention Type DRUG

Paclitaxel

Pemetrexed

Intervention Type DRUG

Pemetrexed

Interventions

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Volrustomig

Volrustomig

Intervention Type DRUG

Pembrolizumab

Pembrolizumab

Intervention Type DRUG

Carboplatin

Carboplatin

Intervention Type DRUG

Paclitaxel

Paclitaxel

Intervention Type DRUG

Pemetrexed

Pemetrexed

Intervention Type DRUG

Eligibility Criteria

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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 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Prescott, Arizona, United States

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Hot Springs, Arkansas, United States

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Springdale, Arkansas, United States

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Long Beach, California, United States

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Lone Tree, Colorado, United States

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Fort Myers, Florida, United States

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Gainesville, Florida, United States

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Orlando, Florida, United States

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St. Petersburg, Florida, United States

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West Palm Beach, Florida, United States

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Fort Wayne, Indiana, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Annapolis, Maryland, United States

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Baltimore, Maryland, United States

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Silver Spring, Maryland, United States

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Towson, Maryland, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Grand Island, Nebraska, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Albuquerque, New Mexico, United States

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East Syracuse, New York, United States

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Fresh Meadows, New York, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Portland, Oregon, United States

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Horsham, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Irving, Texas, United States

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Lancaster, Texas, United States

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Fairfax, Virginia, United States

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Tacoma, Washington, United States

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CABA, , Argentina

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CABA, , Argentina

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CABA, , Argentina

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Córdoba, , Argentina

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Córdoba, , Argentina

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La Plata, , Argentina

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La Plata, , Argentina

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Rosario, , Argentina

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Clayton, , Australia

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Fitzroy, , Australia

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Heidelberg, , Australia

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South Brisbane, , Australia

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Sydney, , Australia

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Linz, , Austria

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Wels, , Austria

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Aalst, , Belgium

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Antwerp, , Belgium

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Ghent, , Belgium

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Barretos, , Brazil

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Curitiba, , Brazil

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Florianópolis, , Brazil

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Fortaleza, , Brazil

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Natal, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre, , Brazil

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Rio de Janeiro, , Brazil

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Santa Cruz do Sul, , Brazil

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São Paulo, , Brazil

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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Barrie, Ontario, Canada

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Oshawa, Ontario, Canada

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Toronto, Ontario, Canada

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Lévis, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Chicoutimi, , Canada

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Changchun, , China

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Changsha, , China

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Chengdu, , China

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Chengdu, , China

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Chongqing, , China

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Fuzhou, , China

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Guangzhou, , China

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Hangzhou, , China

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Hangzhou, , China

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Hefei, , China

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Lanzhou, , China

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Linhai, , China

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Linyi, , China

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Nanchang, , China

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Nanchang, , China

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Nanjing, , China

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Nanning, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Shenzhen, , China

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Taiyuan, , China

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Tianjin, , China

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Wuhan, , China

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Wuhan, , China

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Wuhan, , China

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Xi'an, , China

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Yangzhou, , China

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Zhengzhou, , China

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Olomouc, , Czechia

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Ostrava - Vitkovice, , Czechia

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Prague, , Czechia

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Angers, , France

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Avignon, , France

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Bayonne, , France

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Bordeaux, , France

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Caen, , France

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Lille, , France

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Limoges, , France

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Marseille, , France

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Paris, , France

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Quimper, , France

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Reims, , France

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St-Malo, , France

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Strasbourg, , France

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Suresnes, , France

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Toulon Naval, , France

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Berlin-Zehlendorf, , Germany

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Bonn, , Germany

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Braunschweig, , Germany

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Dresden, , Germany

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Freiburg im Breisgau, , Germany

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Gauting, , Germany

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Georgsmarienhütte, , Germany

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Gütersloh, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Immenhausen, , Germany

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Koblenz, , Germany

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Ludwigsburg, , Germany

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Nuremberg, , Germany

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Tübingen, , Germany

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Velbert, , Germany

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Gyöngyös, , Hungary

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Gyöngyös - Mátraháza, , Hungary

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Győr, , Hungary

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Pécs, , Hungary

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Szekszárd, , Hungary

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Törökbálint, , Hungary

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Bengaluru, , India

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Hyderabad, , India

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Kolkata, , India

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Mysuru, , India

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Nagpur, , India

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Nashik, , India

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Varanasi, , India

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Bari, , Italy

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Bergamo, , Italy

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Milan, , Italy

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Padua, , Italy

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Parma, , Italy

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Pavia, , Italy

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Ravenna, , Italy

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Roma, , Italy

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Bunkyō City, , Japan

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Fukuoka, , Japan

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Kashiwa, , Japan

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Kawasaki-shi, , Japan

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Kōtoku, , Japan

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Matsuyama, , Japan

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Nagoya, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Sagamihara-shi, , Japan

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Sakai, , Japan

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Sapporo, , Japan

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Sendai, , Japan

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Ube-shi, , Japan

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Yokohama, , Japan

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Amsterdam, , Netherlands

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Groningen, , Netherlands

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Nieuwegein, , Netherlands

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Tilburg, , Netherlands

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Lublin, , Poland

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Poznan, , Poland

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Przemyśl, , Poland

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Radom, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Banská Bystrica, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Trnava, , Slovakia

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eManzimtoti, , South Africa

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George, , South Africa

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Johannesburg, , South Africa

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Johannesburg, , South Africa

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Pietermaritzburg, , South Africa

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Pretoria, , South Africa

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Rondebosch, , South Africa

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Soweto, , South Africa

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Cheongju-si, , South Korea

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Daegu, , South Korea

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Incheon, , South Korea

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Jinju, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Suwon, , South Korea

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Suwon, , South Korea

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Alicante, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Bilbao (Vizcaya), , Spain

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Madrid, , Spain

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Málaga, , Spain

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Palma, , Spain

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Kaohsiung City, , Taiwan

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Kaohsiung City, , Taiwan

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New Taipei City, , Taiwan

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Tainan, , Taiwan

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Tainan, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Yunlin, , Taiwan

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Bangkok, , Thailand

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Dusit, , Thailand

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Lampang, , Thailand

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Muang, , Thailand

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Songkhla, , Thailand

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Ankara, , Turkey (Türkiye)

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Antalya, , Turkey (Türkiye)

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Çankaya, , Turkey (Türkiye)

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Diyarbakır, , Turkey (Türkiye)

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Fatih-Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Pamukkale, , Turkey (Türkiye)

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Birmingham, , United Kingdom

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Blackpool, , United Kingdom

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Bury St Edmunds, , United Kingdom

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Colchester, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Truro, , United Kingdom

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Countries

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United States Argentina Australia Austria Belgium Brazil Canada China Czechia France Germany Hungary India Italy Japan Netherlands Poland Slovakia South Africa South Korea Spain Taiwan Thailand Turkey (Türkiye) United Kingdom

Other Identifiers

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2023-000056-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D798AC00001

Identifier Type: -

Identifier Source: org_study_id