WJOG11118L

JRCT ID: jRCTs041200046

Registered date:29/09/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Lung Cancer
• Date of first enrollment: 30/10/2020
• Target sample size: 30
• Study type: Interventional

Intervention(s)

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 3 weeks
B) Pembrolizumab 200mg/body (day 1) + CBDCA AUC 5 (day 1)
+ Pemetrexed 500mg/m2 (day 1), every 3 weeks

(2) Squamous histology, Adeno-squamous histology
A) Pembrolizumab 200mg/body (day 1) + CBDCA AUC 6 (day 1)
+ nab-PTX 100mg/m2 (day1,8,15), every 3 weeks
D) Pembrolizumab 200mg/body (day 1) CBDCA AUC 6 (day 1)
+ PTX 200mg/m2, every 3 weeks

*Patients who required immediate local therapy for CNS metastases could receive radiotherapy before enrollment.

3.2.Local Therapy
Patients will receive local therapies within 21-56 days from the start of last cycle of induction chemotherapy. Patients will receive local therapies determined by a multidisciplinary tumor board (including specialists in thoracic oncology, radiotherapy and thoracic surgery). Local therapies to the primary tumor and all metastases include radiotherapy or surgery (limiting to primary site, regional lymph nodes and pulmonary metastases).

6.3. Maintenance Therapy
Maintenance therapy will start within 42 days from the end of the local therapies. The Patients with non-squamous histology will receive Pembrolizumab + Pemetrexed as maintenance therapy, and those with squamous histology will do Pembrolizumab as maintenance therapy.

(1)Non-squamous histology
Pembrolizumab 200mg/body (day 1) + Pemetrexed 500mg/m2 (day1), every 3 weeks

(2) Squamous histology, Adeno-squamous histology
A) Pembrolizumab 200mg/body (day 1), every 3 weeks
B) Pembrolizumab 400mg/body (day 1), every 6 weeks

Outcome(s)

Primary Outcome

Progression-free survival at 24 months
[Defined as time from date of start date of local therapies until progression or death.]

Secondary Outcome

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.]

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include 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: <=100 IU/L
f)Total bilirubin: <=1.5 mg/dl
g)Serum creatinine: <=1.5 mg/dl
h)SpO2: >=92% in the state of no oxygen inhalation (room climate)

Exclude 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.

Related Information

• Primary Sponsor: Hirotsugu Kenmotsu
• Secondary Sponsor: Miyawaki Taichi,Harada Hideyuki,Ohde Yasuhisa