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: CJLSG1902 - NMC-CJLSG1902

Itani Hidetoshi0 sites60 target enrollmentJuly 14, 2020

Conditionson-squamous non-small cell lung cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: on-squamous non-small cell lung cancer
Sponsor: Itani Hidetoshi
Enrollment: 60
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 14, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Itani Hidetoshi

Eligibility Criteria

Inclusion 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.

Exclusion 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.