Lung Cancer
Conditions
Interventions
All patients will receive 2-4 cycles of systemic treatment, as induction therapy.
(1)Non-squamous NSCLC
A) Pembrolizumab 200mg/body (day 1) + CDDP 75mg/m2 (day1)
+ Pemetrexed 500mg/m2 (day1), every
Sponsors
Hirotsugu Kenmotsu
Miyawaki Taichi
Harada Hideyuki
Ohde Yasuhisa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1.The age is within 20-75 years. 2.Histologically confirmed non-small cell lung cancer 3.No or unknown activating driver mutation: epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), proto-oncogene receptor tyrosine kinase (ROS1), mesenchymal epithelial transition receptor (MET) 4.Patients who have not received prior systemic chemotherapy 5.Synchronous oligo-metastatic stage IV disease: maximum of three distant metastases* *The metastatic lesions will be counted as follows: each lesion will individually be counted as one, and intrathoracic lymph node involvement (defined here as hilar, mediastinal, or supraclavicular nodes, N1-N3) will collectively be counted as one. 6.The patient must be a suitable candidate for local therapy (radiotherapy and/or surgery) to every site of disease, as determined by a multidisciplinary tumor board (including specialists in thoracic oncology, radiology, radiotherapy and thoracic surgery). 7.No malignant ascites, leptomeningeal carcinomatosis and malignant pleural effusion Primary 8.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 9.The functions of the main organs are maintained, and all the criteria stated below are satisfied. a)WBC >= 1500/mm3 b)Neutrophil count >= 1,500 /mm3 c)Hemoglobin: >=9.0 g/dl d)Platelet count: >=100,000/mm3 e)Both AST and ALT: =92% in the state of no oxygen inhalation (room climate)
Exclusion criteria
Exclusion criteria: 1.History of another primary malignancy within 5 years. 2.Active infection requiring therapy. 3.Active Hepatitis B or C. 4.Active autoimmune disease that has required systemic treatment 5.Unsuitable for thoracic radiotherapy by interstitial lung disease or chronic obstructive lung disease 6.Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival at 24 months [Defined as time from date of start date of local therapies until progression or death.] | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity [ Time Frame: Adverse events will be collected from enrollment.] Response rate of induction therapy [ Time Frame: Assessed from the start of protocol treatment until the end of the induction phase.] Progression-free survival [ Time Frame: Assessed from the date of enrolment until progression or death.] Overall survival [ Time Frame: Time from date of enrolment until death from any cause.] Performing rate of local therapy Progression-free survival [ Time Frame: Time from date of start of local therapies until progression or death.] Overall survival [ Time Frame: Time from date of start of local therapies until death from any cause.] | — |
Contacts
Public ContactTaichi Miyawaki
Juntendo University Hospital
Outcome results
None listed