Phase III Study of AK112 for NSCLC Patients

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

420

Participants

Timeline

Start Date

May 4, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Non-Squamous Non-small Cell Lung Cancer
Interventions
DRUG

AK112 Injection

Subjects will receive AK112 Plus Pemetrexed and Carboplatin via intravenous infusion (IV) Q3W, up to 4 cycles. Afterward, AK112 Plus Pemetrexed will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W) up to 2 years.

DRUG

Placebo Injection

Subjects will receive Placebo Plus Pemetrexed and Carboplatin via intravenous infusion (IV) Q3W, up to 4 cycles in treatment periods per the randomization schedule. Afterward, Placebo Plus Pemetrexed will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W) up to 2 years.

Trial Locations (74)

10016

NYU Langone Laura and Isaac Perlmutter Cancer Center, New York

10029

Mount Sinai, New York

12065

New York Oncology/Hematology, Clifton Park

15006

Hospital Teresa Herrera, A Coruña

20133

Istituto Nazionale dei Tumori, Milan

20141

Instituto Europeo di Oncologia, Milan

20817

American Oncology Partners, Bethesda

22031

Virginia Cancer specialisits, Fairfax

27002

Lucus Augusti University Hospital, Lugo

28007

Hospital General Universitario Gregorio Maranon, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28040

Hospital Universitario Clinico San Carlos, Madrid

Instituto de Investigacion Sanitaria-Fundacion Jimenez Diaz, Madrid

28046

Hospital Universitario La Paz, Madrid

28222

Puerta de Hierro University Hospital, Majadahonda

29011

Hospital Regional Universitario de Malaga, Málaga

29425

Medical University South Carolina, Charleston

33136

University of Miami, Miami

33308

The Oncology Institute of Hope & Innovation, Fort Lauderdale

33321

BRCR Global, Tamarac

33322

BRCR Global, Plantation

33401

Florida Cancer Specialists -East, West Palm Beach

33705

Florida Cancer Specialists - North, St. Petersburg

34474

Florida Cancer Associates - Ocala Oncology, Ocala

35016

omplejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria, Las Palmas

38120

Baptist Hospital, Memphis

41014

Hospital Universitario Nuestro Senora de Valme, Seville

43126

University Hospital of Parma, Parma

43219

Zangmeister Cancer Center, Columbus

45014

Oncology Hematology Care, Fairfield

55101

HealthPartners Cancer Research Center, Saint Paul

58102

Sanford Roger Maris Cancer Center, Fargo

69008

Léon Bérard Cancer Center, Lyon, Lyon

70809

Hematology/Oncology Clinic - SCRI, Baton Rouge

75018

Hospital Bichat-Claude Bernard, Paris

75246

Texas Oncology Baylor Charles A. Sammons Cancer Center, Dallas

75248

Institut Curie, Paris

77030

MD Anderson University of Texas, Houston

77598

Texas Oncology Webster, Webster

78745

Texas Oncology South Austin, Austin

80124

Rocky Mountain Cancer Center, Lone Tree

90033

University of Southern California, Los Angeles

90067

Valkyrie Clinical Trials, Los Angeles

90095

UCLA Department of Medicine - Hematology/Oncology, Los Angeles

90602

Presbyterian Intercommunity Hospital, Whittier

92093

UC San Diego, La Jolla

92123

Sharp Memorial Hospital, San Diego

92868

Providence St. Joseph, Orange

UC Irvine, Orange

93309

CBCC Global Research, Bakersfield

94010

CHI Creteil, Créteil

94040

Palo Alto Medical Foundation Research Institute, Mountain View

94115

California Pacific Medical Center, San Francisco

94800

Gustave Roussy Cancer, Villejuif

95403

Providence Medical Foundation, Santa Rosa

95816

Sutter Cancer center, Sacramento

95817

UC DAVIS Comprehensive Cancer Center, Sacramento

97227

Kaiser Permanente Northwest, Portland

97401

Williamette Valley Cancer Institute and Research, Eugene

98684

Compass Oncology, Vancouver

04074

New England Cancer Specialists, Scarborough

02215

Dana Farber Cancer Institute, Boston

T6g 1Z2

Cross cancer Institute, Edmonton

V5Z 4E6

BC Cancer, Vancouver

K1H 8L6

Lung Cancer Canada, Ottawa

M5g 2M9

Princess Margaret Cancer Centre, Toronto

S4T 7T1

Allan Blaire Cancer Centre, Regina

G1V 4G5

Universite Hospital Laval, Québec

00128

Campus Bio-Medico University, Roma

00144

Istituto Nazionale Tumori, Regina Elena, Rome

08035

Vall d'Hebron Institute of Oncology, Barcelona

08916

Badalona-Hospital Germans Trias i Pujol, Barcelona

SW3 6JJ

The Royal Marsden, London

M20 4GJ

The Christie NHS Foundation Trust, Manchester

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Akeso

INDUSTRY

lead

Summit Therapeutics

INDUSTRY