PhaseII study of Atezolizumab plus Chemotherapy in PS 2 Patients With Non-Sq NSCLC

JRCT ID: jRCTs041210030

Registered date:10/06/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Non-Sq non-small cell lung cancer
• Date of first enrollment: 18/08/2021
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Induction phase
Carboplatin AUC=5 day1 q3w
Nab-paclitaxel75mg/m2 day1,8 q3w
Atezolizumab 1200mg/body day1 q3w
up to 4 cycles

Maintenance phase
Atezolizumab 1200mg/body day1 q3w
until disease progression

Outcome(s)

• Primary Outcome: Overall response rate
• Secondary Outcome: Safety, tolerability, overall survival, duration of responce, Progression free survival,6-month progression-free survival rate,PS improvement rate

Key inclusion & exclusion criteria

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

Include criteria

1)Patients with small cell lung cancer (NSCLC) confirmed histologically or cytologically.
2)Patients with stageIV, 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.
A driver genetic mutation positive patient (EGFR, ALK, ROS1,BRAF(V600E),MET, RET, or NTRK) will be eligible for enrollment if they have confirmed disease progression after at least one line of target therapy for each driver gene and no other prior systemic drug therapy.
4)Age of 20 years or older at the time of informed consent
5)ECOG performance status of 2
6)At least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) ver1.1.
7)The latest clinical laboratory test within 7 days prior to enrollment (it is eligible on the same day 1weeks before the enrolment day) meets the following all standard.
1. Neutrophil count >= 1500/mm3
2. Platelet count >= 10.0x10000/mm3
3. Haemoglobin >= 9.0g/dL
4. AST* <= 100IU/L
5. ALT* <= 100IU/L
6. Total bilirubin <= 1.5mg/dL
7. Creatinine <= 1.5mg/dL
8. SpO2 >= 90%(without oxygen administration)
*Patients with documented liver metastases: AST and/or ALT <=200IU/L
8)patients have a life expectancy of at least 12 weeks
9)Patients providing the written informed consent

Exclude criteria

1)Patients with severe complication, such as cerebrovascular disease, transient ischemic attacks, symptomatic heart failure, uncontrollable angina pectoris, or myocardial infarction within 1 year.
2)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)
3)Patients with active Hepatitis B or C. However, HBs antibody-positive or HBc antibody-positive but not active hepatitis with viral DNA load below sensitivity could be included in the study. HCV antibody-positive but not active hepatitis, could be included in the study.
4)The presence of evident interstitial pulmonary disease (idiopathic interstitial pneumonia, pneumoconiosis, irradiation pneumonitis, drug-induced pneumonitis, etc), that is clinically symptomatic or evident on chest X-ray or chest CT. however clinically stable opacity caused by radiotherapy could be enrolled in the study.
5)Patients with autoimmune disease or history of active autoimmune disease which requires systemic steroid treatment.
6)Patients receiving systemic steroids at doses higher than 10 mg/day of prednisolone equivalent for non- autoimmune diseases. Patients treated with immunosuppressive agents.
7)A history of severe hypersensitivity to carboplatin, nab-paclitaxel, or atezolizumab.
8)Symptomatic brain metastasis required for radiation therapy or surgical resection. Patients who are appropriately treated and neurologically stable for 7 days before the enrollment, and does not require an increase of steroid dose, can be enrolled.
9)Patients with carcinomatous meningitis.
10)Patients with pleural, ascites, or pericardial effusion which requires continuous drainage. If the effusion is controlled and the drain can be removed before the treatment, the patients can be enrolled in the study.
Cases with pleurodesis two weeks before enrollment can be enrolled.
11)Patients treated with palliative radiotherapy within 7 days prior to enrolment
12)Severe complications such as uncontrollable hypertension, diabetes mellitus, active gastrointestinal bleeding, or observed congestive heart failure, unstable angina, myocardial infarction within 6 months.
13)Pregnant, breastfeeding, or has possibility of pregnant and is unwilling to use contraception.
14)Patients who are different for the participation in the study by complication of mental disease or psychiatric symptom.
15)Any other patients who are regarded as unsuitable for this study by the investigators.

Related Information

• Primary Sponsor: Murakami Haruyasu