Preoperative Nivolumab (Opdivo) to evaluate pathologic response in patients with stage I non-small cell lung cancer: a phase 2 trial

JRCT ID: jRCT2061180016

Registered date:29/01/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: non small cell lung cancer
• Date of first enrollment: 03/04/2019
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Nivolumab (240 mg/body) is administrated i.v. as preopierative therapy on day 1 of 2-week cycle for a total of 3 cycles. After period of the preoperative therapy, inclucing discontinuation of nivolumab administration, radical surgery is performed for all operable patients.

Outcome(s)

• Primary Outcome: pathological CR rate(IPR)

Secondary Outcome

1) Safety (adverse event to 90 days post-operation)
2) Response rate (RECIST v1.1)(IPR)
3) Major pathological response rate (IPR)
4) Overall survival

Key inclusion & exclusion criteria

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

Include criteria

1) Histologically or cytologically confirmed Non Small Cell Lung Cancer
2) Resectable NSCLC patients with clinical stage I (by UICC-TNM ver. 8), defined as having a high risk of reccurrence (pure solid or solid tumor size:2-4cm)
3) ECOG PS 0-1
4) Have a measurable target lesion, designated by RECIST ver.1.1
5) Patients with no serious disease which make the surgery to be impossible to do
6) Patient who is considered capable of lobectomy
7) Age: More than 20 years old
8) Meet the defined criteria of the results of laboratory tests on screening visit
9) For Women of Childbearing Potential (WOCBP), the result of pregnancy test (14 or less days before enrollment) is negative
10) WOCBP who has agreed with contraception until 5 months after last administration of nivolumab
11) Patient with written informed consent for participation of the study
12) Patient who observed the rules about scheduled visit, study schedule, and laboratory tests

Exclude criteria

1) Positive for EGFR mutation (deletion of exon 19, or point mutation on exon21, L858R), ALK translocation or ROS 1 translocation tests
2) Known or suspected autoimmune disease
3) Patients requiring treatment with systemic corticosteroids (over 10 mg/day dose) or immunosuppressants within 14 days before enrollment
4) Receive or plan to receive live or attenuated vaccine within 28 days prior to registration
5) Patients who have obvious interstitial lung disease or pulmonary fibrosis by chest CT test
6) Patients with concomitant or a history of tuberculosis
7) Patients who have serious or uncotrollable disease
8) Patients who have prior therapy with chemotherapy or any other anti-cancer therapy for early stage of NSCLC
9) Patients who have medical history of treatment with anti PD-1 antibody, anti PD-L1/L2 antibody, anti CTLA-4 antibody or any other antibody for inhibition or modulation of T cell costimulatory pathway
10) Positive for HBs antigen, HCV antibody, HIV antibody or HTLV-1 antibody tests
11) Negative for HBs antigen test, but positive for HBs or HBc antibody test and positive for HBV-DNA quantitative test
12) Females who are pregnant, lactating or suspected pregnancy
13) Patients who have a treatment history of active malignant tumor within 3 years before enrollment
14) Patients who have a medical history of allergy or hypersensitivity to ingredients of nivolumab
15) Patients with psychosis or dementia to interfere to obtain informed consent appropriately
16) Patients who have diverticulitis or symptomatic peptic ulcer disease
17) Patients who have medical history of hematopoietic stem cell transplantation
18) Patients whom the physicians in the study consider inappropriate for entry

Related Information

• Primary Sponsor: Okada Morihito
• Source(s) of Monetary Support: ONO PHARMACEUTICAL CO., LTD.