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

Phase 3

Recruiting

• Conditions: advanced non-small-cell lung cancer

• Registration Number: JPRN-jRCT1031190032
• Lead Sponsor: OHE Yuichiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 172

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified