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Phase III study of multidisciplinary therapy combined local ablative therapy with immune-checkpoint inhibitors for patients with synchronous oligometastatic NSCLC (J-OLIGO: WJOG20924L)

Phase III study of multidisciplinary therapy for patients with synchronous oligometastatic NSCLC

Yamamoto Nobuyuki

Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN

wjog@wjog.jp

Takeda Koji

West Japan Oncology Group

Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN

+81-6-6633-7400

datacenter@wjog.jp

Recruiting

Oct. 10, 2025

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1) Aged >_18 years at the time of informed consent.
2) Written informed consent obtained after adequate explanation of the study.
3) Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
4) Negative or unknown status for driver mutations/ rearrangements (EGFR, ALK, RET, ROS1, BRAF V600E, MET exon 14 skipping, KRAS G12C, HER2, NTRK).
5) No prior chemotherapy for NSCLC.
6) No radiotherapy or surgery for NSCLC within the past 5 years.
7) Diagnosed with stage IVA or IVB NSCLC with 1 - 3 metastatic lesions.
8) Eligible for surgery of thoracic lesions or definitive radiotherapy for the primary and all metastatic sites, as judged by thoracic surgeons and radiation oncologists.
9) No malignant pleural or pericardial effusion, pleural/leptomeningeal/peritoneal dissemination, ascites, or carcinomatous lymphangitis.
10) ECOG Performance Status of 0 or 1.
11) No significant dysfunction of major organs; meets protocol-defined laboratory criteria.

1) Patients with active double cancers.
2) Patients with localized infections requiring treatment or active systemic infections.
3) Patients positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody.
4) Pregnant or lactating women, women who may currently be pregnant, or patients unwilling to use contraception.
5) Patients judged to be unsuitable for enrollment due to clinically significant psychiatric disorders.
6) Patients with a history of, or currently diagnosed with, autoimmune diseases or chronic/recurrent autoimmune disorders.
7) Patients with poorly controlled diabetes mellitus despite appropriate therapy.
8) Patients with symptomatic congestive heart failure, unstable angina, or a history of myocardial infarction within one year prior to enrollment.
9) Patients deemed unsuitable for thoracic radiotherapy or surgery due to interstitial lung disease, severe COPD, or similar conditions.
10) Patients receiving systemic corticosteroids (>_10 mg/day of prednisolone equivalent) or immunosuppressive therapy.
11) Patients requiring intermittent bronchodilators or inhaled corticosteroids for asthma, or topical steroids, may be included.
12) Patients with a history of severe hypersensitivity reactions to other monoclonal antibodies.
13) Patients with known hypersensitivity to any of the study drugs.
14) Patients with superior vena cava syndrome or airway obstruction requiring urgent local treatment.
15) Patients deemed inappropriate for study participation by the investigator for any other reason.

Both

Synchronous oligometastatic non-small cell lung cancer

In this trial, patients with stage IV non-small-cell lung cancer will receive four cycles of pembrolizumab combined with platinum-based chemotherapy as induction therapy. Those who achieve disease control on induction will undergo a second registration and be randomized 1:1 to the investigational arm or the standard-of-care arm.

Investigational arm: Local ablative treatment is applied to all residual lesions, followed by maintenance therapy that includes an immune-checkpoint inhibitor.

Standard-of-care arm: Patients receive maintenance therapy including an immune-checkpoint inhibitor.

non-small cell lung cancer, Synchronous oligometastatic disease

immune-checkpoint inhibitors, multidisciplinary therapy, local ablative therapy

Overall survival, defined as the time from the date of randomization at secondary registration

Safety of induction therapy, Tumor response to induction therapy, Progression-free survival measured from the date of randomization at secondary registration, Proportion of patients who received local ablative therapy, Progression-free survival measured from the date of primary registration, Overall survival measured from the date of primary registration, Safety after secondary registration, Pattern of disease progression after secondary registration

+81-55-989-5222

Sept. 16, 2025

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