NIPH Clinical Trials Search

JRCT ID: jRCT1061200024

Registered date:23/10/2020

Phase II Trial of Carboplatin, Etoposide and Atezolizumab for Previously Untreated Elderly Patients with Advanced Small cell lung cancer

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedPerformance status 0-2
Date of first enrollment07/12/2020
Target sample size32
Countries of recruitment
Study typeInterventional
Intervention(s)Carboplatin, Etoposide, and Atezolizumab are administered every 3 weeks for up to 4 courses (induction thera-py), and then Atezolizumab is administered until disease progression or discontinuation criteria are met (maint-enance therapy).


Primary Outcome1-year survival rate
Secondary OutcomeOverall survival, progression-free survival, response rate, safety, etc.

Key inclusion & exclusion criteria

Age minimum>= 71age old
Age maximumNot applicable
Include criteria1) A definitive diagnosis of small cell lung cancer has been obtained by histology or cytology. 2) Diagnosed as advanced type (ED) by chest CT, head CT or MRI, PET-CT, etc. 3) No serious tumor-related complications. 4) The age of the registration date is 71 years or older. 5) Performance status (PS) is 0-2 according to the ECOG standard. 6) Has measurable lesions. 7) No history of surgery, radiation therapy, or chemotherapy for small cell lung cancer. 8) No surgery, chest radiation therapy, or chemotherapy within 1 year for other cancers. 9) The general condition is good, and the functions of blood, kidney, liver, etc. can be maintained. 10) Patient consent is obtained in writing from the patient.
Exclude criteria1) Patients with positive HIV antibody. 2) Patients who are HCV antibody positive and HCV-RNA positive. 3) Patients positive for HBs antigen, HBc antibody or HBs antibody. 4) Patients with autoimmune diseases including past medical history. 5) Patients with complications such as active interstitial lung disease and active radiation pneumoni tis. 6) Patients with tuberculosis. 7) Patients undergoing dialysis. 8) Patients with severe liver dysfunction. 9) Patients with severe impairment of cardiovascular system and respiratory function. 10) Patients with a history of Grade 3 or higher hypersensitivity to immune checkpoint inhibitors, ca rboplatin or etoposide. 11) Patients with endocrine disorders that are difficult to control. 12) Patients with active inflammatory bowel disease. 13) Patients who receive continuous systemic administration of steroids over 5 mg/day in terms of predonin. 14) Patients with uncontrolled diabetes (HbA1c 8.0% or more). 15) Patients in need of double cancer treatment. 16) Patients who cannot consent to contraception by contraception methods such as condoms for 6 months after the consent is obtained and the therapeutic drug administration is completed. 17) Patients with severe infections. 18) Patients with mental disorders or dementia who have trouble obtaining proper consent. 19) Patients who have undergone transplantation therapy such as hematopoietic stem cell transpla ntation. 20) Patients who are judged to be unsuitable by the investigator or investigator.

Related Information


Public contact
Name Yuka Kato
Address 2-5-1, Shikata-cho, Kita-ku, Okayama Okayama Japan 700-8558
Telephone +81-86-235-6507
Affiliation Okayama University Hospital
Scientific contact
Name Yuka Kato
Address 160 Kou Minamiumemoto-machi, Matsuyama, Ehime Ehime Japan 791-0280
Telephone +81-89-999-1111
Affiliation NHO Shikoku Cancer Center