A phase 2 study of atezolizumab with carboplatin plus pemetrexed followed by maintenance atezolizumab with pemetrexed for elderly patients with advanced non-squamous non-small cell lung cancer

JRCT ID: jRCTs041200032

Registered date:14/07/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Non-squamous non-small cell lung cancer
• Date of first enrollment: 14/07/2020
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Atezolizumab : 1200 mg/body of Atezolizumab is intravenously infused on day 1.
Carboplatin : AUC5 of Carboplatin is intravenously infused on day 1.
Pemetrexed : 500 mg/m2 of Pemetrexed is intravenously infused on day 1.
Folic acid : Folic acid 0.5 mg on Day 1.
Starting administration at least 7 days before the start date of pemetrexed administration,
continuously taking oral medication from the last day of pemetrexed administration until the 22nd day.
Vitamin B12 : 1 mg intramuscularly.
starting administration 7 days or more before the start of pemetrexed administration,
continuing every 9 weeks from the last dose of pemetrexed to the 22nd day.

Outcome(s)

• Primary Outcome: Progression-Free Survival

Secondary Outcome

Overall Survival
Progression-Free Survival rate
Overall response rate
PD-L1 TPS Progression-Free Survival
PD-L1 TPS Overall Survival
PD-L1 TPS Progression-Free Survival rate
PD-L1 TPS Overall Survival rate
Adverse event rate

Key inclusion & exclusion criteria

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

Include criteria

1) Provided written informed consent after a thorough explanation of the study contents prior to the study registration.
2) Age of 75 years or older on the day of informed consent.
3) Confirmed cancer any of adenocarcinoma, large cell carcinoma (excluding large cell neuroendocrine carcinoma), and unclassified cancer by histological examination or cytology. With tumors that showed non-small cell mixed tissue images (squamous and non-squamous epithelium) if the pathologist determines that more than 50% of the tissues are non-squamous.
4) Confirmed both negative EGFR gene mutation including uncommon mutation and negative ALK fusion gene in tissue or cytological specimens, with the results of PD-L1 (TPS by 22C3 antibody) expression found.
5) Patients with stage IV, stage III, or postoperative recurrence who are unable to undergo radical radiation therapy.
6) Without symptomatic brain metastases or meningeal carcinomatosis. However, if the patient's neurological recovery from radiation therapy (CTCAE v5.0 grade 0-1) has been maintained for at least 2 weeks before registration (on the same day two weeks before), the patient is eligible. (For steroid administration for brain metastasis, registration is possible if the equivalent amount is 10 mg / day or less in prednisolone conversion)
7) Without Grade 3 or greater superior vena cava syndrome, pericardial effusion, pleural effusion, or ascites. For pleural effusion, if Grade 3 or greater superior pleural effusion is not seen 2 weeks after the drainage is stopped after intrathoracic injection of Unitalc or Picibanil, registration is possible.
8) With at least one measurable lesion based on RECIST ver 1.1.
9) An example of untreated cytotoxic anticancer drug and immune checkpoint inhibitor as advanced stage lung cancer (stage IV). Preoperative and postoperative chemotherapy (limited to cytotoxic anticancer drugs) is acceptable if the final dose is at least 6 months prior to registration in this clinical study.
10) Without history of definitive chemoradiotherapy within 6 months (since the last irradiation for radiation therapy alone, or since completion of the last of chemotherapy or radiotherapy for chemoradiotherapy. Similarly, patients underwent preoperative radiation (radiation therapy as preoperative adjuvant chemoradiotherapy) is eligible if six months have passed since the last treatment.
11) In a certain period of time elapsed since the previous treatment at the time of registration. (Registration is possible on the same day.)
12) ECOG Performance Status 0-1.
13) Absence of severe impairments of major organs with satisfactory clinical examination results at the treatment start under the criteria. (The clinical laboratory data within 14 days prior to the registration, the same day of the week two weeks before is acceptable.)
14) LIfe expectancy of 12 weeks or more from the treatment start date.

Exclude criteria

1) Has known active double cancer.
2) Previous treatment for surgery, radiation therapy, or chemotherapy for other cancer types. However, for surgery, radiation therapy, or hormonal therapy for other types, it applies to the cases less than 3 years after completion who can be evaluated as complete cure can be registered. Patients with history of oral chemotherapy as adjuvant chemotherapy for other cancer types can be registered if it has past less than 5 years after the completion of oral administration.
3) With local or systemic active infections requiring surgical treatment such as drainage.
4) HBs antigen-positive, or HBc antibody-positive and/or HBs antibody-positive and HBV-DNA -positive.
5) With active tuberculosis. (Registration is possible if a patient have completed standard treatment and are considered inactive.)
6) With complication of symptomatic cerebrovascular disorder or history within 1 year before registration.
7) With uncontrolled or severe cardiovascular disease including myocardial infarction or unstable angina, that occurred within 1 year before enrollment, congestive heart failure of NYHA Class II or higher, or severe arrhythmias with continuous treatment.
8) With uncontrollable bronchopulmonary hemorrhage or blood sputum.
9) With clear interstitial lung disease findings on CT. Even if CT does not reveal interstitial lung disease, patients who have received oral steroids or intravenous therapy as interstitial lung disease in the past are also excluded.
10) Received radiation therapy to the lung that exceeds 30 Gy within 6 months.
11) With an autoimmune disease or a history of an autoimmune disease requiring steroid therapy.
12) Those require continuous systemic administration of steroids (internal or intravenous) other than autoimmune diseases and those using immunosuppressants. However, steroid administration for brain metastasis can be registered if it is equivalent to prednisolone of 10 mg/day or less.
13) With spinal cord compression.
14) With gastrointestinal obstruction or peritoneal carcinomatosis.
15) With a history of severe hypersensitivity who have hypersensitivity to the components or additives of this drug.
16) Whose enrollment in this clinical study is deemed difficult due to clinically relevant mental illness.
17) Other cases judged by the investigator to be inappropriate.

Related Information

• Primary Sponsor: Itani Hidetoshi
• Source(s) of Monetary Support: Central Japan Lung Study Group(CJLSG)