Study Results
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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ACTIVE_NOT_RECRUITING
PHASE3
420 participants
INTERVENTIONAL
2023-05-04
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AK112 in combination with Pemetrexed and Carboplatin
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.
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.
Placebo in combination with Pemetrexed and Carboplatin
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent. (For patients from North America and Europe, there will be no upper age cutoff)
3. ECOG performance status score of 0 or 1.
4. Expected survival ≥3 months.
5. Histologically or cytology-confirmed, locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC (according to TNM staging of lung cancer, 8th edition) that cannot be completely resected by surgery and cannot receive radical concurrent/sequential chemoradiation.
6. EGFR activation mutations that are confirmed by tumor histology or cytology or blood test before enrollment (eg, exon 18 point mutations, exon 19 deletions, exon 20 point mutations, and exon 21 point mutations). Patients must provide a previous EGFR mutation test report, otherwise tumor tissue samples, peripheral blood samples, or pleural fluid samples will need to be collected for EGFR status testing prior to enrollment.
7. Prior treatment with EGFR TKI and treatment failure, meeting any of the following requirements: Progression after treatment with first- or second-generation EGFR TKI, and confirmation of absence of T790M mutation after progression (only for patients enrolled in China). Progression after treatment with a third-generation EGFR TKI (eg, osimertinib, ametinib, vometinib). Note, for North America and Europe patients only.
8. According to RECIST v1.1, there is at least 1 measurable noncerebral lesion.
9. Adequate organ function determined by the following requirements
10. Female patients of childbearing age have a negative serum pregnancy test result within 3 days before the first dose
11. If a female patient of childbearing potential has sex with an unsterilized male partner, the patient must use a highly effective method of contraception from the beginning of screening and must agree to continue using these precautions until 120 days after the last dose of the study drug or until 6 months after the last carboplatin and pemetrexed dose (whichever is longer).
12. If an unsterilized male patient has sex with a female partner of childbearing potential, the patient must use an effective method of contraception from the beginning of screening to day 120 after the last dose or until 6 months after the last carboplatin and pemetrexed dose (whichever is longer). The decision to stop contraception after this time point should be discussed with investigator.
Exclusion Criteria
2. Patients who have received immune checkpoint inhibitors (eg, anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-LAG-3 antibodies, etc.)
3. Received prior systemic chemotherapy, anti-angiogenic therapy, or more than one prior line of antitumor therapy (other than EGFR inhibitors) for advanced stage (IIIB to IV) NSCLC.
4. Concurrent enrollment in another clinical study, unless it is a noninterventional clinical study or the follow-up period of the interventional study is more than 4 weeks from the last dose of the prior clinical study or more than 5 half-lives of the prior study drug, whichever is shorter.
5. Received EGFR inhibitor therapy within 2 weeks (with the exception of osimertinib to be within 7 days) prior to the first dose; received nonspecific immunomodulatory therapy (eg, interleukin, interferon, thymus peptide, tumor necrosis factor) within 2 weeks prior to the first dose, excluding IL-11 for the treatment of thrombocytopenia; have received Chinese herbal medicines or proprietary Chinese medicines with antitumor indications within 1 week before the first dose.
6. Imaging during the screening period shows that the tumor surrounds important blood vessels or has obvious necrosis and/or cavitation of tumor lesions within the lung parenchyma.
7. Imaging during the screening period shows that the tumor invades the surrounding vital organs and blood vessels, such as the heart and pericardium, trachea, esophagus, aorta, superior vena cava, or patient is at risk of esophageal tracheal fistula or esophageal pleural fistula.
8. Symptomatic metastases of the central nervous system.
9. Malignant tumors other than NSCLC within 3 years before the first dose.
10. Active autoimmune disease requiring systemic therapy (eg, with disease-modifying drugs, corticosteroids, immunosuppressant therapy) within 2 years prior to the first dose (excluding ir AEs due to PD-1/L1 inhibitors). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent) for adrenal or pituitary insufficiency) is permitted.
11. There is a history of major diseases before the first dose
12. History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection, complicated by chronic diarrhea) within 6 months before the first study drug administration.
13. Patients with \>30 Gy of chest radiation therapy within 6 months prior to the first dose, nonthoracic radiation therapy \>30 Gy within 4 weeks prior to the first dose, and palliative radiation therapy of ≤30 Gy within 2 weeks prior to the first dose and failed to recover from the toxicity and/or complications of these interventions to NCI CTCAE Grade ≤1 (except hair loss and fatigue). Palliative radiotherapy for symptom control is permitted if it has been completed at least 2 weeks before the first dose, and no additional radiotherapy for the same lesion is planned.
14. Inactivated vaccines are allowed. Patients are excluded if they have received a live vaccine or live attenuated vaccine within 4 weeks prior to the first dose, or if they are scheduled to receive a live vaccine or live attenuated vaccine during the study period.
15. Severe infection within 4 weeks prior to the first dose, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection that has received systemic anti-infective therapy within 2 weeks prior to the first dose (excluding antiviral therapy for hepatitis B or C)
18 Years
ALL
No
Sponsors
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Akeso
INDUSTRY
Summit Therapeutics
INDUSTRY
Responsible Party
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Locations
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CBCC Global Research
Bakersfield, California, United States
UC San Diego
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, United States
Palo Alto Medical Foundation Research Institute
Mountain View, California, United States
Providence St. Joseph
Orange, California, United States
UC Irvine
Orange, California, United States
Sutter Cancer center
Sacramento, California, United States
UC DAVIS Comprehensive Cancer Center
Sacramento, California, United States
Sharp Memorial Hospital
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
Providence Medical Foundation
Santa Rosa, California, United States
Presbyterian Intercommunity Hospital
Whittier, California, United States
Rocky Mountain Cancer Center
Lone Tree, Colorado, United States
The Oncology Institute of Hope & Innovation
Fort Lauderdale, Florida, United States
University of Miami
Miami, Florida, United States
Florida Cancer Associates - Ocala Oncology
Ocala, Florida, United States
BRCR Global
Plantation, Florida, United States
Florida Cancer Specialists - North
St. Petersburg, Florida, United States
BRCR Global
Tamarac, Florida, United States
Florida Cancer Specialists -East
West Palm Beach, Florida, United States
Hematology/Oncology Clinic - SCRI
Baton Rouge, Louisiana, United States
New England Cancer Specialists
Scarborough, Maine, United States
American Oncology Partners
Bethesda, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
HealthPartners Cancer Research Center
Saint Paul, Minnesota, United States
New York Oncology/Hematology
Clifton Park, New York, United States
NYU Langone Laura and Isaac Perlmutter Cancer Center
New York, New York, United States
Mount Sinai
New York, New York, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
Zangmeister Cancer Center
Columbus, Ohio, United States
Oncology Hematology Care
Fairfield, Ohio, United States
Williamette Valley Cancer Institute and Research
Eugene, Oregon, United States
Kaiser Permanente Northwest
Portland, Oregon, United States
Medical University South Carolina
Charleston, South Carolina, United States
Baptist Hospital
Memphis, Tennessee, United States
Texas Oncology South Austin
Austin, Texas, United States
Texas Oncology Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
MD Anderson University of Texas
Houston, Texas, United States
Texas Oncology Webster
Webster, Texas, United States
Virginia Cancer specialisits
Fairfax, Virginia, United States
Compass Oncology
Vancouver, Washington, United States
Cross cancer Institute
Edmonton, Alberta, Canada
BC Cancer
Vancouver, British Columbia, Canada
Lung Cancer Canada
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Allan Blaire Cancer Centre
Regina, Saskatchewan, Canada
Universite Hospital Laval
Québec, , Canada
CHI Creteil
Créteil, , France
Léon Bérard Cancer Center, Lyon
Lyon, , France
Hospital Bichat-Claude Bernard
Paris, , France
Institut Curie
Paris, , France
Gustave Roussy Cancer
Villejuif, , France
Istituto Nazionale dei Tumori
Milan, , Italy
Instituto Europeo di Oncologia
Milan, , Italy
University Hospital of Parma
Parma, , Italy
Campus Bio-Medico University
Roma, , Italy
Istituto Nazionale Tumori, Regina Elena
Rome, , Italy
Hospital Teresa Herrera
A Coruña, , Spain
Vall d'Hebron Institute of Oncology
Barcelona, , Spain
Badalona-Hospital Germans Trias i Pujol
Barcelona, , Spain
omplejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria
Las Palmas, , Spain
Lucus Augusti University Hospital
Lugo, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Instituto de Investigacion Sanitaria-Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Puerta de Hierro University Hospital
Majadahonda, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Hospital Universitario Nuestro Senora de Valme
Seville, , Spain
The Royal Marsden
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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Other Identifiers
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AK112-301 (HARMONi)
Identifier Type: -
Identifier Source: org_study_id
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