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

Phase II Trial of Carboplatin, Etoposide and Atezolizumab for Previously Untreated Elderly Patients with Advanced Small cell lung cancer (OLCSG 2002-EPAS trial) - OLCSG 2002-EPAS trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1061200024
Enrollment
32
Registered
2020-10-23
Start date
2020-12-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Performance status 0-2 Small-cell lung cancer, elderly

Interventions

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 cri
D046650

Sponsors

Kato Yuka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) 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.

Exclusion criteria

Exclusion criteria: 1) 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.

Design outcomes

Primary

MeasureTime frame
1-year survival rate

Secondary

MeasureTime frame
Overall survival, progression-free survival, response rate, safety, etc.

Contacts

Public ContactYuka Kato

Okayama University Hospital

y-katorinu@okayama-u.ac.jp+81-86-235-6507

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026