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A phase II study of atezolizumab plus chemotherapy for elderly patients with ED-SCLC

Phase II study of carboplatin, etoposide, and atezolizumab for elderly patients with extensive stage small-cell lung cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041210002
Enrollment
40
Registered
2021-04-02
Start date
2021-04-02
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

Small cell lung cancer

Interventions

Induction phase Carboplatin AUC=5 day1 q3w Etoposide 80mg/m2 day1,2,3 q3w Atezolizumab 1200mg/body day1 q3w up to 4 cycles Maintenance phase Atezolizumab 1200mg/body day1 q3w until disease pro

Sponsors

Takahashi Toshiaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with small cell lung cancer (SCLC) confirmed histologically or cytologically. 2) Patients with extensive stage, postoperative recurrence, or postchemoradiotherapy recurrence 3) Previously untreated patients. Any postoperative chemotherapy or chemoradiotherapy given at least 6 months before enrollment in the present study is acceptable. 4) Age of 75 years or older at the time of informed consent 5) ECOG performance status of 0-2 6) The latest clinical laboratory test within 14 days prior to enrollment (it is eligible on the same day 2 weeks before the enrolment day) meets the following all standard. 1. Neutrophil count >= 1500/mm3 2. Haemoglobin >= 8.0g/dL 3. Platelet count >= 10.0x10000/mm3 4. AST = 50mL/min 9. SpO2 >= 90% 7) patients have a life expectancy of at least 3 months 8) Patients providing the written informed consent.

Exclusion criteria

Exclusion criteria: 1) Symptomatic brain metastasis required for radiation therapy or surgical resection. 2) Patients with severe complication, such as cerebrovascular disease, transient ischemic attacks, symptomatic heart failure, uncontrollable angina pectoris, or myocardial infarction within 1 year. 3) Patients with active double cancer (synchronous double cancer and asynchronous double cancer within 3 years of progression-free period. However, the lesions correspondent to carcinoma in situ and intramucosal carcinoma curable by topical treatment are excluded) 4) Patients treated with palliative radiotherapy within 7 days prior to enrolment 5) Patients with active Hepatitis B or C. 6) History of interstitial pulmonary disease, drug-induced interstitial pulmonary disease and irradiation pneumonitis required for steroidal treatment. 7) Patients with autoimmune disease or history of active autoimmune disease that has required systemic treatment 8) Patients treated with systemic steroids at doses higher than 10 mg/day of prednisolone equivalent for non- autoimmune diseases or patients treated with immunosuppressive agents. 9) Urgent radiotherapy because of symptom of superior vena cava syndrome. 10) Patients who are different for the participation in the study by complication of mental disease or psychiatric symptom. 11) Patients with anamnesis of hypersensitivity to ingredients of the drug. 12) Any other patients who are regarded as unsuitable for this study by the investigators.

Design outcomes

Primary

MeasureTime frame
12-months overall survival rate

Secondary

MeasureTime frame
Response rate, Progression free survival, Overall survival, Safety

Contacts

Public ContactKazushige Wakuda

Shizuoka Cancer Center

k.wakuda@scchr.jp+81-55-989-5222

Outcome results

None listed

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