NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1051190091

Registered date:08/01/2020

Docetaxel plus Ramucirumab immediately after treatment with ICI

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiednon-small cell lung cancer
Date of first enrollment27/05/2020
Target sample size35
Countries of recruitment
Study typeInterventional
Intervention(s)Docetaxel (60 mg / m2, day 1) and ramucirumab (10 mg / kg, day 1) are administered by infusion every 3 weeks until the protocol treatment discontinuation criteria are met.

Outcome(s)

Primary OutcomeOverall response rate
Secondary Outcomeoverall survival, progression free survival, disease control rate, safety

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1. Written informed consent to participate in this study. 2. Histologically and/or cytologically proven non-small cell lung cancer. 3. Patients who have unresectable clinical stage IIIB, IIIC, or IV, post-operative recurrence or recurrence after radical radiation therapy. 4. Patient who have measurable lesions. 5. More than twenty years old at the time of the agreement acquisition 6. ECOG Performance Status 0-1 7. Meets the following criteria within 14 days before registration a: leukocyte count: >=3000/mm3 b: neutrophil count: >=1500/mm3 c: hemoglobin: >=9.0 g/dL d: platelet count: >=100,000/mm3 e: total bilirubin: <=1.5mg/dl f: AST and ALT: <=100IU/L (<=200IU/L, in case of liver metastasis) g: Cre: <=1.5mg/dl or CCr: >=40mL/min h: PT-INR: <=1.5 i: SpO2: >=92% (room air) j: protein urea: <=1+ If the amount of proteinuria is 2+ or more, it is eligible if the amount of proteinuria in 24 hours is less than 1000 mg. If measurement by 24 hour urine storage is difficult, measure the urinary protein quantification result (mg / dL) / urinary creatinine concentration (mg / dL) ratio, and substitute that value as the 24 hour urinary protein amount (g). 8. Patients who have previously treated with immu ne checkpoint inhibitor and chemotherapy (It doesn't matter if it's simultaneous or sequential) 9. Patients who received treatment including ICI in the previous treatment 10. Patients with up to 2 lines of treatment so far 11. Patients who have passed the final day of the final course of previous treatment at the time of enrollment. 12. Patients with a history of radiation therapy could participate in the study if: a: at least 3 months after chest radiation therap y. b: at least 7 days after local or palliative radiation therapy (including stereotactic radiation to the central nervous system and whole-brain radiation)
Exclude criteria1. Patient with active double cancer. 2. Patient with infectious diseases that require systemic treatment. 3. Active interstitial pneumonitis, fibroid lung confirmed by CT. 4. Uncontrollable diabetes. 5. Uncontrollable hypertension despite standard medical management. 6. congestive heart failure (NYHA II-IV) and arrhythmias that cannot be controlled with drugs. 7. Patients with intestinal obstruction. patients with a history of inflammatory bowel disorders, extensive bowel resection, Crohn's disease, ulcerative colitis or chronic diarrhea. 8. Patients with a history of uncontrollable thrombosis / embolism. 9. HBs antigen positive. 10. HBs antibody or HBc antibody is positive and HBV-DNA is positive. 11. Patient with HIV-related diseases. 12. Patient with impaired mental status. 13. Child-Pugh B (or more severe) cirrhosis, or history of hepatic encephalopathy or cirrhosis with clinically significant ascites (regardless of severity). 14. Patients with grade 3 or higher peripheral neuropathy. 15. Pregnancy. 16. Symptomatic brain metastases or spinal metastases that require radiation or surgery. 17. Symptomatic superior vena cava syndrome. 18. Patient with much ascetic fluid, pleural effusion, cardiac effusion. 19. Image findings. a. Obvious tumor invasion to main thoracic vessel or main blood vessel stenosis b. Cavity in the tumor c. Tumor exposure to the central airway to the regional branch 20. Patients who have undergone surgery with general anesthesia within 28 days, subcutaneous venous access devices in place within 7 days, or postoperative bleeding complications or wound complications due to surgical treatment within 2 months. 21. History of ramucirumab treatment. 22. Receiving steroids in excess of 10mg/day prednisolone equivalent. 23. Patients who have used study drug or unapproved therapy within the past 3 months. Registration is possible if the doctor in charge determines that the effect and safety will not be affected. 24. Fever over 38 25. History of bleeding within 2 months 26. Patients with arterial thrombosis such as myocardial infarction, unstable angina, cerebrovascular attack or transient ischemic attack within 6 months. 27. Serious or non-healing wounds, ulcers or fractures within 28 days 28. Serious bleeding disorders, vasculitis or Grade 3 or higher gastrointestinal bleeding within 3 months 29. Patient with gastrointestinal perforation within 6 months. 30. History of hypersensitivity to the components of the study drug. 31. Patients scheduled for major surgery during the study period.

Related Information

Contact

Public contact
Name Mayako Yamashita
Address 811-1, Kimiidera, Wakayama Wakayama Japan 641-8510
Telephone +81-73-441-0619
E-mail yayamama@wakayama-med.ac.jp
Affiliation Wakayama Medical University Hospital
Scientific contact
Name Hiroaki Akamatsu
Address 811-1, Kimiidera, Wakayama Wakayama Japan 641-8510
Telephone +81-73-441-0619
E-mail h-akamat@wakayama-med.ac.jp
Affiliation Wakayama Medical University Hospital