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JCOG2317: Neoadjuvant Chemotherapy with Immune Checkpoint Inhibitor Followed by Surgery vs. Upfront Surgery in Patients with c-stage II-III Non-small-cell Lung Cancer (NATCH-ICI)

JCOG2317: Neoadjuvant Chemotherapy with Immune Checkpoint Inhibitor Followed by Surgery vs. Upfront Surgery in Patients with c-stage II-III Non-small-cell Lung Cancer (NATCH-ICI)

TSUTANI Yasuhiro

Kindai University Hospital

377-2, Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan

tsutani@med.kindai.ac.jp

HAMADA Akira

Kinki University Hospital

377-2, Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan

+81-72-366-0221

a-hamada@med.kindai.ac.jp

Recruiting

Mar. 26, 2025

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

(1) Cytologically or histologically confirmed non-small cell lung cancer.
(2) Diagnosed as clinical stage II or III (UICC TNM classification, 9th edition) with all of the following criteria (i)-(iii).
(i) For the primary tumor, all of the following are met.
[a] Absence of direct invasion into the diaphragm, mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, carina, or separate tumor in another lobe of the ipsilateral lung.
[b] Not superior sulcus tumor.
(ii) For the lymph nodes, any of the following are met.
[a] N0-1
[b] N2a without extranodal extension, and with cytological or histological confirmation.
(iii) Determined to be amenable to radical resection by lobectomy (including bi-lobectomy).
(3) No or unknown EGFR gene mutations (exon 19 deletion or L858R mutation) and ALK fusion gene
(4) Age 18 years or older.
(5) Eastern Cooperative Group (ECOG) Performance Status 0-1.
(6) Eligible regardless of PD-L1 expression.
(7) Measureable or non-measureable.
(8) No prior chemotherapy, radiotherapy, or immunotherapy for any malignancy within 2 years.
(9) No history of previous thoracic surgery with the exception of the following:
(i) Thoracoscopic resection of a bulla.
(ii) Thoracoscopic surgery without resection of the lung, esophagus, and mediastinum.
(iii) Wedge resection of a benign tumor on the contralateral side.
(10) No history of radiotherapy to the lung, hilum, or mediastinum for other cancers.
(11) No prior surgery with general anesthesia within 14 days.
(12) No findings suggestive of interstitial lung disease or pulmonary fibrosis on the chest computed tomography.
(13) No active autoimmune disease.
(14) The patient tolerates lobectomy and meets all of the following:
(i) Predicted postoperative volume in 1 second (ppoFEV1.0) is >= 800 mL.
(ii) Preoperative resting SpO2 >= 92%. If the resting SpO2 is < 92%, PaO2 is >= 65 torr.
(15) Adequate organ funcion.
(16) Written informed consent for this study.

(1) Synchronous or metachronous (within 2 years) malignancy, with the exception of intramucosal tumors curatively treated with local therapy.
(2) Infectious disease requiring systemic treatment.
(3) Body temperature >= 38.0C at the time of the registration.
(4) Females during pregnancy, within 28 days of post parturition, or during lactation, or males who expect a partner's pregnancy.
(5) Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and make participation in the study difficult.
(6) Receiving continuous systemic administration (oral or intravenous) of steroids (more than 10 mg/day of prednisone equivalent) or other immunosuppressive drugs.
(7) Poorly controlled diabetes mellitus (HbA1c > 8%).
(8) Poorly controlled hypertension.
(9) History of unstable angina (angina that developed or worsened within the last 3 weeks) or a myocardial infarction within 6 months.
(10) Poorly controlled valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
(11) Severe emphysema based on chest CT.
(12) Positive for serum hepatitis B surface, antigen hepatitis C antibody or HIV antibody
(13) Under disulfiram, cyanamide, or procarbazine treatments.

Both

non-small-cell lung cancer

Arm A: Adjuvant therapy [1. surgery, 2. adjuvant cisplatin-based chemotherapy, 3. immune checkpoint inhibitor monotherapy].
Arm B: Neoadjuvant therapy [1. neoadjuvant nivolumab plus chemotherapy, 2. surgery].

Overall survival

Progression-free survival, cumulative incidence of local relape, cumulative incidence of distant relapse, time to distant metastasis, objective response rate of neoadjuvant therapy, pathological complete response rate, major pathological response rate, a proportion of R0 resection, a proportion of protocol treatment completion, adverse event

+81-4-7133-1111

Mar. 04, 2025

No

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