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

JRCT ID: jRCTs041210002

Registered date:02/04/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Small cell lung cancer
• Date of first enrollment: 30/09/2021
• Target sample size: 40
• Study type: Interventional

Intervention(s)

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 progression

Outcome(s)

• Primary Outcome: 12-months overall survival rate
• Secondary Outcome: Response rate, Progression free survival, Overall survival, Safety

Key inclusion & exclusion criteria

• Age minimum: >= 75age old
• Age maximum: Not applicable
• Gender: Both

Include 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 <= 100IU/L
5. ALT <= 100IU/L
6. Total bilirubin <= 1.5mg/dL
7. Creatinine <= 1.2mg/dL
8. Creatinine clearance >= 50mL/min
9. SpO2 >= 90%
7) patients have a life expectancy of at least 3 months
8) Patients providing the written informed consent.

Exclude 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.

Related Information

• Primary Sponsor: Takahashi Toshiaki