Enhancing ICI

JRCT ID: jRCTs031200109

Registered date:08/09/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 08/03/2021
• Target sample size: 35
• Study type: Interventional

Intervention(s)

(1)Continuing an ICI
*nivolumab 240mg div biweekly or 480mg every 4 weeks
*pembrolizumab 200mg div triweekly, 400mg div every 6 weeks
*atezolizumab 1200mg div triweekly
*nivolumab 360mg div triweekly and ipilimumab 1 mg/kg every 6 weeks
(2)Palliative radiation therapy
Palliative radiation at a total dose of 2Gy x 20-25 or the equivalent dose (for example, 3Gyx10) to any organ with lung cancer except for the brain.
(3)Ancer
*Ancer 0.05-1.0 mL
*Twice a week
*From the start of radiation to the end of radiation (up to 8 weeks)
(4)Nine months later from the entry, repeating from (1) to (3) to another field may be performed. Within 9 months, palliative radiotherapy alone to other parts may be performed due to pain and so on.

Outcome(s)

• Primary Outcome: Safety (Adverse events graded by CTCAE version 5.0), Progression-free survival rate at 9 months (by extramural review based on RECIST version 1.1)

Secondary Outcome

(1)Objective response rate, disease control rate
(Extramural review based on RECIST version 1.1)
(2)Progression-free survival
(Extramural review based on RECIST version 1.1)
(3)Treatment duration of an ICI
(4)Overall Survival
(5)2 years survival rate
(6)Changes in immunocompetent cells

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

(1)Patients with a diagnosis of non-small cell lung cancer (NSCLC).
(2)EGFR mutation positive , EGFR mutation negative, or unknown
(3)Patients that are in stage IIIb, IIIc or stage IVa, IVb, IVc or have recurrence postoperatively without indication for surgical or radical radiation therapy.
(4)Inactive ICI by nivolumab, pembrolizumab, atezolizumab or ipilimumab+nivolumab, as defined by
*disease progression in stable disease (SD) or progressive disease (PD) with longitudinal elevation (>=2 points) of a tumor marker [*] from 8 to 12 weeks after starting an ICI
*progressive disease (PD) after 12 weeks after starting an ICI
*stable disease (SD) with longitudinal elevation (>=2 points) of a tumor marker [*] after 12 weeks after starting an ICI
[*]CEA, SLX, CA19-9, CYFRA, SCC, proGRP, NSE
(5)Having a palliative radiation field except for brain metastasis, and having a measurable lesion(s) evaluated by RECIST (version1.1) outside of the palliative radiation field
(6)From 20 to 79 years of age
(7)PS 0 or 1 (ECOG)
(8)Normal main organ functions (in principle, they should have the following values.)
1)Absolute neutrophil count >1,500/mm3
2)Hemoglobin >= 9.0 g/dl
3)Platelet count >= 100,000/mm3
4)AST,ALT <= 2.5 times ULN if no demonstrable liver metastases or <= 5 times ULN in the presence of liver metastases
5)Total bilirubin <= 1.5 times ULN if no liver metastases or <= 3 times ULN in the presence of documented liver metastases
6)Creatinine clearance < 1.5 mg/dl
7)SpO2 >= 95 %
(9)Life expectancy >= 12 weeks
(10)Written informed consent must be given

Exclude criteria

(1)Patients with synchronous multiple cancer or metachronous multiple cancer with <=5 years of disease-free interval
(2)Patients with interstitial pneumonia (UIP, probable UIP) confirmed by chest CT, drug -induced Interstitial lung disease or clinically active interstitial lung disease
(3)Any evidence of active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
(4)Patients with primary immunodeficiency
(5)Patients with disease that has an impact on digestive function, such as total gastrectomy or active inflammatory bowel disease.
(6)Active or prior documented inflammatory bowel disease such as Crohn's Disease, and ulcerative colitis.
(7)Patients with severe complications such as uncontrolled heart, lung, liver, or kidney disease.
(8)Patients that have received systemic administration of steroids at a dose of more than 10mg of prednisolone (or equivalent to this) for 4 weeks or longer.
(9)Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
(10)Active or prior documented autoimmune disease within the past 2 years.
(11)Patients with corrected QT interval (QTc) > 470 msec calculated from ECG
(12)Male patients without an intention to use the measures of contraception. Or pregnant women, lactating women, women who are positive for pregnancy tests or women without an intention to use the measures of contraception.
(13)Known allergy or hypersensitivity to any of the study drugs
(14)History of allogenic organ transplantation
(15)Previously treatment by Z-100 (Ancer)
(16)Other cases that are determined to be inappropriate by attending physicians.

Related Information

• Primary Sponsor: Kobayashi Kunihiko
• Secondary Sponsor: Nonprofit Organization, North East Japan Study Group