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

JRCT ID: jRCT1031190032

Registered date:28/05/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: advanced non-small-cell lung cancer
• Date of first enrollment: 01/07/2019
• Target sample size: 200
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(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.

Exclude criteria

(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.

Related Information

• Primary Sponsor: OHE Yuichiro
• Source(s) of Monetary Support: National Cancer Center Japan,Japan Agency for Medical Research and Development