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
- Conditions
- Neoplasms
- Registration Number
- KCT0004541
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 26
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.
•White blood cells = 2 x 103/µL and Absolute neutrophil count (ANC) = 1,500/µL
•Platelets = 100 x 103/µL
•Hemoglobin = 9.0 g/dL
•AST (SGOT) and ALT (SGPT) = 3.0-fold the upper limit of normal (ULN) of the study site (or =5.0-fold the ULN of the study site in patients with liver metastases)
•Total bilirubin = 1.5-fold the ULN of the study site
•Creatinine = 1.5-fold the ULN of the study site or creatinine clearance (either the measured or estimated value using the Cockcroft-Gault equation) > 45 mL/min
10. Women of childbearing potential (including women with chemical menopause or no menstruation for other medical reasons) #1 must agree to use contraception#2 from the time of informed consent until 5 months or more after the last dose of the investigational product. Also, women must agree not to breastfeed from the time of informed consent until 5 months or more after the last dose of the investigational product.
11. Men must agree to use contraception#2 from the start of study treatment until 7 months or more after the last dose of the investigational product.
#1. Women of childbearing potential are defined as all women after the onset of menstruation who are not postmenopausal and have not been surgically sterilized (e.g., hysterectomy, bilateral tubal ligation, bilateral oophorectomy). Postmenopause is defined as amenorrhea for =12 consecutive months without specific reasons. Women using oral contraceptives, intrauterine devices, or mechanical contraception such as contraceptive barriers are regarded as having childbearing potential.
#2. The subject must consent to use any two of the following methods of contraception: vasectomy or condom for patients who are male or female subject’s partner and tubal ligation, contraceptive diaphragm, intrauterine device, spermicide, or oral contraceptive for patients who are female or male subject’s partner.
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
11. Patients who have experienced a transient ischemic attack, cerebrovascular accident, thrombosis, or thromboembolism (pulmonary arterial embolism or deep vein thrombosis) within 180 days before enrollment
12. Patients with a history of uncontrollable or significant cardiovascular disease meeting any of the following criteria:
- Myocardial infarction within 180 days before enrollment
- Uncontrollable angina pectoris within 180 days before enrollment
- New York Heart Association (NYHA) Class III or IV congestive heart failure
- Uncontrollable hypertension despite appropriate treatment (e.g., systolic blood pressure =150 mmHg or diastolic blood pressure = 90 mmHg lasting 24 hours or more)
- Arrhythmia requiring treatment
13. Patients receiving or requiring anticoagulant therapy for a disease. Patients receiving antiplatelet therapy including low-dose aspirin may be enrolled.
14. Patients with uncontrollable diabetes mellitus
15. Patients with systemic infections requiring treatment
16. Patients who have received systemic corticosteroids [except for temporary use (e.g., for examination or prophylaxis of allergic reactions) or use for pneumonitis treatment] or immunosuppressants within 28 days before enrollment
17. Patients who have received chemotherapy within 14 days before enrollment
18. Patients who have undergone surgical adhesion of the pleura or pericardium within 28 days before enrollment
19. Patients who have undergone surgery under general anesthesia within 28 days before enrollment
20. Patients who have undergone surgery involving local or topical anesthesia within 14 days before enrollment
21. Patients who have received radiotherapy within 14 days before enrollment, or radiotherapy to bone metastases within 14 days before enrollment
22. Patients who have undergone CyberKnife or Gamma knife treatment 14 or fewer days before enrollment
23. Patients who have received any radiopharmaceuticals (excep
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS), defined as the time from the date of study enrollment to the date of first documented disease progression or death of any cause, whichever occurs first. Disease progression will be determined on the basis of investigator assessment with use of RECIST Guideline version 1.1.
- Secondary Outcome Measures
Name Time Method Overall survival (OS), defined as the time from study enrollment to death from any cause;Objective response rate (ORR), defined as the proportion of patients with Objective response;Safety profile