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JCOG2302: Randomized phase III trial comparing nivolumab therapy and S-1 therapy in the second-line treatment of non-small cell lung cancer with interstitial pneumonitis (NICE IP)

JCOG2302: Randomized phase III trial comparing nivolumab therapy and S-1 therapy in the second-line treatment of non-small cell lung cancer with interstitial pneumonitis (NICE IP)

Kogure Yoshihito

National Hospital Organization Nagoya Medical Center

4-1-1, Sannomaru, Naka-ku Nagoya-shi, Aichi

yoshihito.kogure@nnh.go.jp

Kogure Yoshihito

National Hospital Organization Nagoya Medical Center

4-1-1, Sannomaru, Naka-ku Nagoya-shi, Aichi

+81-52-951-1111

yoshihito.kogure@nnh.go.jp

Recruiting

Oct. 25, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

(1) Cytologically (including biopsy) or histologically confirmed non-small cell lung cancer.
(2) Stage IV, postoperative recurrent disease,
(3) For prior systemic therapy:
(i) No prior S-1 or immune checkpoint inhibitors
(ii) Refractory/intolerant to first-line platinum-based therapy (excluding S-1) for NSCLC
(iii) >=168 days since last non-immune checkpoint inhibitor anticancer drug in neo/adjuvant therapy
(4) Suspected ILD on imaging, meeting all:
(i) No known cause (e.g., collagen disease, drug-induced, sarcoidosis, hypersensitivity pneumonitis)
(ii) Chest CT shows:
(a) No honeycomb sign
(b) HRCT pattern: Probable UIP, Indeterminate for UIP, or Alternative diagnosis (ATS/ERS/JRS/ALAT 2018)
(iii) No history of acute ILD exacerbation
(iv) Antinuclear antibody <80x
(v) %VC >=80%
(vi) If biopsied, not diagnosed as UIP or Probable UIP with honeycomb signs
(5) EGFR mutation negative for non-squamous NSCLC
(6) ALK, ROS1, BRAF(V600E), MET exon 14 skipping, RET, NTRK fusions negative/unknown
(7) Age >=18 at registration
(8) ECOG PS 0-1
(9) Eligible regardless of PD-L1 (22C3) expression.
(10) Measurable lesions not required
(11) No Grade >=3 SVC syndrome, pericardial effusion, pleural effusion, ascites, symptomatic brain metastases, leptomeningeal carcinomatosis, or spinal metastases requiring radiation or surgery
(12)
(i) Palliative radiation for non-CNS metastases: >=7 days (exclude if >30 Gy to thorax within 168 days)
(ii) Stereotactic RT/gamma knife for CNS metastases: >=7 days
(iii) Whole brain RT: >=14 days
(iv) Drainage
(v) Pleurodesis
(vi) Transfusion, hematopoietic factors
(vii) Incisional biopsy, trauma treatment
(viii) Surgery under general anesthesia
(13) No autoimmune diseases
(14) Adequate organ function
(15) Written informed consent

(1) Synchronous double or multiple cancer or metachronous double or multiple cancer within 2 years.
(2) Systemic infection requiring treatment
(3) Fever >=38.0 degrees Celsius at registration
(4) During pregnancy, within 28 days of postparturition, or during lactation.
(5) Psychiatric disorders or symptoms interfering with daily life, deemed unsuitable for trial participation
(6) Continuous systemic administration of steroids >10 mg/day prednisolone equivalent or other immunosuppressants
(7) Poorly controlled diabetes despite appropriate treatment
(8) History of cerebrovascular event within 1 year
(9) Two or more transient ischemic attacks
(10) Symptomatic congestive heart failure, unstable angina, or myocardial infarction within 6 months
(11) Clinically serious arrhythmia on the electrocardiogram.
(12) Hypersensitivity to S-1 or nivolumab

Both

Advanced non-small cell lung cancer without driver gene alteration

Group A
S-1 (80-120 mg/body) days 1-14, every 3 weeks for 1 course, up to 1 year from the start of protocol treatment

Group B
Nivolumab (240 mg) day 1, every 2 weeks for 1 course, up to 1 year from the start of protocol treatment

Overall Survival

Progression-free survival, Response rate, Time to exacerbation of ILD (Interstitial Lung Disease), Adverse events, Serious adverse events

+81-4-7133-1111

Sept. 05, 2024

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