New hope for lung cancer patients whose first treatment stopped working

NCT ID NCT06396065

Disease control Sponsor: Summit Therapeutics Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times

Summary

This study tests whether adding the experimental drug AK112 to standard chemotherapy can help people with a specific type of advanced lung cancer (non-squamous non-small cell lung cancer with an EGFR mutation) whose cancer has worsened after initial targeted therapy. About 420 participants will receive either AK112 or a placebo, plus two chemotherapy drugs, to see if the combination slows cancer growth and improves survival. The goal is to find a better treatment option for patients who have limited choices after their first therapy fails.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

420 people

The number who actually took part.

Started

May 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed. 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: 1. Histologic or cytopathologic evidence of the presence of a small cell carcinoma component, or a predominantly squamous cell carcinoma. 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)

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-squamous non-small cell lung cancer

Contacts and locations

Locations

Allan Blaire Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada
American Oncology Partners

Bethesda, Maryland, 20817, United States
BC Cancer

Vancouver, British Columbia, V5Z 4E6, Canada
BRCR Global

Plantation, Florida, 33322, United States
BRCR Global

Tamarac, Florida, 33321, United States
Badalona-Hospital Germans Trias i Pujol

Barcelona, 08916, Spain
Baptist Hospital

Memphis, Tennessee, 38120, United States
CBCC Global Research

Bakersfield, California, 93309, United States
CHI Creteil

Créteil, 94010, France
California Pacific Medical Center

San Francisco, California, 94115, United States
Campus Bio-Medico University

Roma, 00128, Italy
Compass Oncology

Vancouver, Washington, 98684, United States
Cross cancer Institute

Edmonton, Alberta, T6g 1Z2, Canada
Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Florida Cancer Associates - Ocala Oncology

Ocala, Florida, 34474, United States
Florida Cancer Specialists - North

St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists -East

West Palm Beach, Florida, 33401, United States
Gustave Roussy Cancer

Villejuif, 94800, France
HealthPartners Cancer Research Center

Saint Paul, Minnesota, 55101, United States
Hematology/Oncology Clinic - SCRI

Baton Rouge, Louisiana, 70809, United States
Hospital Bichat-Claude Bernard

Paris, 75018, France
Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain
Hospital Regional Universitario de Malaga

Málaga, 29011, Spain
Hospital Teresa Herrera

A Coruña, 15006, Spain
Hospital Universitario Clinico San Carlos

Madrid, 28040, Spain
Hospital Universitario La Paz

Madrid, 28046, Spain
Hospital Universitario Nuestro Senora de Valme

Seville, 41014, Spain
Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain
Institut Curie

Paris, 75248, France
Instituto Europeo di Oncologia

Milan, 20141, Italy
Instituto de Investigacion Sanitaria-Fundacion Jimenez Diaz

Madrid, 28040, Spain
Istituto Nazionale Tumori, Regina Elena

Rome, 00144, Italy
Istituto Nazionale dei Tumori

Milan, 20133, Italy
Kaiser Permanente Northwest

Portland, Oregon, 97227, United States
Lucus Augusti University Hospital

Lugo, 27002, Spain
Lung Cancer Canada

Ottawa, Ontario, K1H 8L6, Canada
Léon Bérard Cancer Center, Lyon

Lyon, 69008, France
MD Anderson University of Texas

Houston, Texas, 77030, United States
Medical University South Carolina

Charleston, South Carolina, 29425, United States
Mount Sinai

New York, New York, 10029, United States
NYU Langone Laura and Isaac Perlmutter Cancer Center

New York, New York, 10016, United States
New England Cancer Specialists

Scarborough, Maine, 04074, United States
New York Oncology/Hematology

Clifton Park, New York, 12065, United States
Oncology Hematology Care

Fairfield, Ohio, 45014, United States
Palo Alto Medical Foundation Research Institute

Mountain View, California, 94040, United States
Presbyterian Intercommunity Hospital

Whittier, California, 90602, United States
Princess Margaret Cancer Centre

Toronto, Ontario, M5g 2M9, Canada
Providence Medical Foundation

Santa Rosa, California, 95403, United States
Providence St. Joseph

Orange, California, 92868, United States
Puerta de Hierro University Hospital

Majadahonda, 28222, Spain
Rocky Mountain Cancer Center

Lone Tree, Colorado, 80124, United States
Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58102, United States
Sharp Memorial Hospital

San Diego, California, 92123, United States
Sutter Cancer center

Sacramento, California, 95816, United States
Texas Oncology Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States
Texas Oncology South Austin

Austin, Texas, 78745, United States
Texas Oncology Webster

Webster, Texas, 77598, United States
The Christie NHS Foundation Trust

Manchester, M20 4GJ, United Kingdom
The Oncology Institute of Hope & Innovation

Fort Lauderdale, Florida, 33308, United States
The Royal Marsden

London, SW3 6JJ, United Kingdom
UC DAVIS Comprehensive Cancer Center

Sacramento, California, 95817, United States
UC Irvine

Orange, California, 92868, United States
UC San Diego

La Jolla, California, 92093, United States
UCLA Department of Medicine - Hematology/Oncology

Los Angeles, California, 90095, United States
Universite Hospital Laval

Québec, G1V 4G5, Canada
University Hospital of Parma

Parma, 43126, Italy
University of Miami

Miami, Florida, 33136, United States
University of Southern California

Los Angeles, California, 90033, United States
Valkyrie Clinical Trials

Los Angeles, California, 90067, United States
Vall d'Hebron Institute of Oncology

Barcelona, 08035, Spain
Virginia Cancer specialisits

Fairfax, Virginia, 22031, United States
Williamette Valley Cancer Institute and Research

Eugene, Oregon, 97401, United States
Zangmeister Cancer Center

Columbus, Ohio, 43219, United States
omplejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria

Las Palmas, 35016, Spain

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