A phase II study evaluating the effect of Nivolumab in combination with palliative radiationtherapy in previously treated patients with NSCLC

JRCT ID: jRCTs051180174

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non small cell lung cancer
• Date of first enrollment: 07/10/2016
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Novolumab 240mg/body, palliative radiation therapy

Outcome(s)

• Primary Outcome: Response rate(extra field of radiation therapy)
• Secondary Outcome: Overall survival, Progression free survival, disease control rate, Toxicity,

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Over 20 years old
2.Histologically or cytologically proven non-small cell lung cancer(except LCNEC)
3.Stage IIIB, stage IV or recurrent disease after surgery
4.Previously treated with systemic chemotherapy
4-1.EGFR/ALK negative or unknown patient must receive previously platinum doublet chemotherapy. (over 75years old, monotherapy is allowed)
4-2.EGFR or ALK positive patient must previously receive both platinum doublet chemotherapy and molecular targeted drug.
5.Patients suitable for palliative radiation therapy
6.Patients who have at least one measurable lesion outside palliative radiation field
7.ECOG PS 0-2
8.Patients are expected to live over 90days
9.SpO2>=92 or PaO2>=60mmHg
10.adequate organ function (seg.>1500/ad, Plt.>100000/eq, Hb>9.0/>0, AST(GOT) and ALT(GPT) < three times normal range, Cr<1.5 or CCR>45ml/min)
11.Patients with or without brain metastasis are eligible
12.Do not need for steroid
13.more than 14 days of interval after pretreatment.(In case of EGFR-TKI and ALK-TKI, more than 7days of interval after pretreatment)
14 .Written informed consent

Exclude criteria

1.History of severe drug allergy
2.Side effects of previously treatment is existed and disturb safety analysis
3.urrent or previous History of auto immune disease
4.Pulmonary fibrosis detected by chest CT or clinical examination
5.current or previous history of diverticulitis or ulcerative disease of GI
6.History of active double cancer within 5 years
7.History of pericardial effusion/pleural effusion/ascites with treatment needed.
8.Brain metastasis required for radiation therapy
9.uncontrolled pain due to bone metastasis
10.Current or previous (within the last 180days) history of symptomatic cerebrovascular disease or thromboembolism.
11.Uncontrollable severe cardiovascular disease
12.Uncontrollable diabetes mellitus
13.previous(within the last 14 days) pleurodesis
14.previous(within the last 28 days) operation with systemic anesthesia
15.previous (within the last 56 days) thoracic radiation therapy with over 40Gy.
16.systemic infectious disease require treatment.
17.Active hepatitis type B or typeC
18.Sever side effect caused by previously treated immune checkpoint blockade.
19.Histry of active psychological disease
20.Histry of dementia
21.Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Related Information

• Primary Sponsor: Satouchi Miyako
• Source(s) of Monetary Support: Ono Pharmaceutical Co.,ltd.,Bristol-Myers Squibb K.K.
• Secondary ID(s): UMIN000023646