KCT0004541
Recruiting
未知
Open-Label, Single arm, Phase II trial to evaluate efficacy and safety of Nivolumab as maintenance therapy following Platinum-based chemotherapy in non-small cell lung cancer patients after tyrosine kinase Inhibitor therapy
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Asan Medical Center
- Enrollment
- 26
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Sex: Male or female
- •2\. Age (at the time of informed consent): 18 years and older
- •3\. Patients with histologically\- or cytologically\-confirmed advanced, metastatic, or recurrent non\-small cell lung cancer \[according to edition 8 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology]
- •4\. Patients whose disease had progressed after one or two TKIs treatment with targetable driver mutation including EGFR mutation, ALK fusion, and ROS1 rearrangement.
- •(Allowed TKIs must be approved by the local health authority, including but not limited to gefitinib, erlotinib, afatinib, dacomitinib, osimertinib, alectinib, brigatinib, crizotinib and ceritinib)
- •5\. Patients who did not shown disease progression at the time of finishing four cycles of Platinum\-based chemotherapy after TKI therapy failure
- •6\. Patients who have at least 1 measurable lesion per the RECIST Guideline Ver. 1\.1\. If patients only have lesions that were previously treated with radiation, the lesion should be limited to one with confirmed aggravation by imaging after radiation.
- •7\. Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 or 1
- •8\. Patients with a life expectancy of at least 3 months
- •9\. Patients whose latest laboratory data meet the below criteria. Of note, laboratory data will not be valid if the patient has received a granulocyte colony\-stimulating factor (G\-CSF) or blood transfusion within 14 days before testing.
Exclusion Criteria
- •1\. Patients with known SCLC transformation
- •2\. Patients with multiple primary cancers (with the exception of completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, or superficial bladder cancer, or any other cancer that has not recurred for at least 5 years)
- •3\. Patients with residual adverse effects of prior therapy or effects of surgery that would affect the safety evaluation of the investigational product in the opinion of the investigator
- •4\. Patients with current or past history of severe hypersensitivity to any other antibody products
- •5\. Patients with concurrent autoimmune disease or history of chronic or recurrent autoimmune disease (17\.3 List of autoimmune disease). Patients with controlled asthma in the opinion of the investigator may be enrolled.
- •6\. Patients with a current or past history of interstitial lung disease diagnosed based on imaging or clinical findings. Patients with radiation pneumonitis may be enrolled if the radiation pneumonitis has been confirmed as stable (beyond acute phase) without any concerns about recurrence.
- •7\. Patients with concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease
- •8\. Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment. Patients may be enrolled if the metastasis is asymptomatic and requires no treatment.
- •9\. Patients with pericardial fluid, pleural effusion, or ascites requiring treatment
- •10\. Patients with uncontrollable, tumor\-related pain
Outcomes
Primary Outcomes
Not specified
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