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JCOG1701: Randomized phase III study comparing cessation or continuation of PD-1 Pathway Blockade for patients with advanced non-small-cell lung cancer (SAVE study)

JCOG1701: Randomized phase III study comparing cessation or continuation of PD-1 Pathway Blockade for patients with advanced non-small-cell lung cancer (SAVE study)

GOTO Yasushi

National Cancer Center Hospital

5-1-1 Tsukiji, Chuo-ku, Tokyo

ygoto@ncc.go.jp

SATOMI Eriko

National Cancer Center Hospital

5-1-1 Tsukiji, Chuo-ku, Tokyo

+81-3-3547-5293

CRL_office@ml.res.ncc.go.jp

Not Recruiting

May. 28, 2019

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

(1) Histologically confirmed non-small cell lung cancer (adenocarcinoma, squamous carcinoma, LCNEC, carcinoid tumor, large-cell carcinoma, adenosquamous carcinoma, sarcomatoid cancer, unclassifiable cancer, and salivary gland tumor) or cytologically (including biopsy) confirmed non-small cell lung cancer (adenocarcinoma, squamous carcinoma, adenocarcinoma-suggested, squamous-suggested, LCNEC-suggested, and NOS).
(2) Treated with anti-PD-1 or anti-PD-L1 inhibitor for 52 weeks or more and not over 62 weeks.
(3) Remarkable response of anti-PD-1 or anti-PD-L1 inhibitor measured by comparing CT imaging of before the treatment and that of taken within 4 weeks before the enrollment.
(4) 20 years of age or older.
(5) ECOG performance status, 0 or 1.
(6) None of the treatment below should be done within 8 weeks before the enrollment.
(i) radiotherapy (for metastatic sites).
(ii) chest drainage for more than 24 hours.
(iii) pleurodesis.
(iv) surgery with general anesthesia.
(7) No adverse reactions with grade 3 or more, related to anti-PD-1 or PD-L1 inhibitors.
(8) No pneumonitis with grade 3 or more, even not related to the pretreated anti-PD-1 or PD-L1 inhibitors.
(9) No active, chronic or recurrent autoimmune disease.
(10) No symptomatic brain metastasis, meningeal carcinoma, and spinal metastasis which needs radiotherapy or surgery.
(11) No superior vena cava syndrome, pericardial water retention, pleural effusion, and ascites with grade 3 or more.
(12) Adequate function of major organs.
(13) Written informed consent.

(1) Synchronous or metachronous (within 2 years) malignancies. (2) Infectious disease requiring systemic treatment. (3) Pyrexia of 38 or higher degrees centigrade. (4) Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy. (5) Severe psychological disorders. (6) Patients requiring systemic steroids medication or immunosuppressants for non-autoimmune disease.
(7) Poorly controlled diabetes mellitus. (8) Poorly controlled hypertension. (9) History of unstable angina pectoris with new onset or exacerbation within recent 3 weeks or myocardial infarction within 6 months before registration.
(10) Positive HBs antigen.

Both

advanced non-small-cell lung cancer

Arm A (Standard arm): Continue the treatment including anti-PD-1 or anti-PD-L1 inihibitor treated before enrollment.
Arm B (Test arm): Discontinue the anti-PD-1 or anti-PD-L1 inhibitor treated before enrollment.

overall survival

progression-free survival, time to failure of strategy, adverse events, serious adverse events, response rate of patients who restarted anti-PD-1 or anti-PD-L1 inhibitors (calculated for those allocated to arm B), and progression-free survival of patients who restarted anti-PD-1 or anti-PD-L1 inhibitors (calculated for those allocated to arm B)

+81-4-7133-1111

Mar. 14, 2019

No

none