Phase II study of IRInotecan after COmbined immunotherapy for extensive-disease small cell lung cancer

JRCT ID: jRCTs071210090

Registered date:04/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Extensive-disease small cell lung cancer
• Date of first enrollment: 22/11/2021
• Target sample size: 30
• Study type: Interventional

Intervention(s)

- UGT1A1 gene polymorphism is wild type for both * 6 and * 28
: Irinotecan monotherapy (100 mg / m2, day1, 8, 15 every 4 weeks)
- UGT1A1 gene polymorphism is * 6 or * 28 hetero zygous
: Irinotecan monotherapy (80 mg / m2, day1, 8, 1 5 every 4 weeks)
- UGT1A1 gene polymorphism is * 6 or * 28 homoz ygous, * 6 and * 28 complex heterozygous
: Irinotecan monotherapy (60 mg / m2, day1, 8, 15 every 4 weeks)
It will continue until disease progression and unac ceptable toxicity are confirmed.

Outcome(s)

• Primary Outcome: Response Rate
• Secondary Outcome: overall survival, progression-Free survival, safety

Key inclusion & exclusion criteria

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

Include criteria

1) A definitive diagnosis of small cell lung cancer h as been obtained by histological or cytological exa mination.
2) A case of re-exacerbation after combined immunotherapy for small cell lung cancer
(Both sensitive relapse and refractory relapse are possible)
3) Cases with ECOG Performance status (PS) 0-2
4) Age at the time of obtaining consent is 20 years or older
5) No active double cancer (simultaneous double cancer / multiple cancer and metachronous doubl e cancer / multiple cancer with no disease period within 5 years. However, carcinoma in situ that is c onsidered to be cured by local treatment Does not include lesions equivalent to carcinoma in situ )
6) Written consent has been obtained from the pa tient after a sufficient explanation of the study con tent has been given prior to enrollment in the stud y.
7) The latest test results within 14 days before reg istration (the same day 2 weeks before the registra tion date is possible) satisfy all of the following: Ne utrophil count equal or more than 1,500/uL, Platelet count equal or more than 100 x 103 / uL, Total bilirubin (T-Bil) equal or less than 1.5 mg / dL, AST equal or less than 100 U / L, ALT equal or less than 100 U / L, Serum creatinine (Cr) equal or less than 1.5 mg / dL, Room air SpO2 equal or mor e than 92%

Exclude criteria

1) Cases with interstitial pneumonia that can be p ointed out by plain chest X-ray
2) Chest irradiation within 28 days
3) Symptoms of superior vena cava syndrome are observed and urgent radiotherapy is required
4) Have serious heart disease such as uncontrolled angina or heart failure, and myocardi al infarction within 3 months
5) Have uncontrolled diabetes
6) Have uncontrolled hypertension
7) Have an infectious disease with systemic treatm ent
8) Pregnant, potentially pregnant, within 28 days o f childbirth, lactating women, men wishing to beco me pregnant with their partner
9) Have a fever of 38.0 or higher at the time of regi stration
10) It is judged that it is difficult to participate in t he test due to complications of mental illness or p sychiatric symptoms that interfere with daily life. 11) Received continuous systemic administration ( oral or intravenous) of steroids or immunosuppres sive drugs equivalent to prednisolone 11 mg / day or higher
12) HBsAg positive
13) HIV antibody positive (HIV antibody can be un tested)
14) Have other complications that are judged to in terfere with the administration of treatment

Related Information

• Primary Sponsor: Mukae Hiroshi
• Secondary ID(s): Nil known