Phase III Study of PEM + CDDP and VNR + CDDP for Completely Resected Non-squamous Non-Small Cell Lung Cancer

JRCT ID: jRCTs041180023

Registered date:20/12/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Completely Resected Non-squamous Non-Small Cell Lung Cancer
• Date of first enrollment: 14/03/2012
• Target sample size: 800
• Study type: Interventional

Intervention(s)

arm A: Vinorelbine + Cisplatin
arm B: Pemetrexed + Cisplatin

Outcome(s)

• Primary Outcome: Disease-free survival
• Secondary Outcome: Overall survival, Rate of treatment completion, Adverse events

Key inclusion & exclusion criteria

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

Include criteria

1) Histologically confirmed non-squamous NSCLC. Adenosquamous carcinoma is eligible if the squamous cell carcinoma component is less than 50%.
2) Pathologic stage II or IIIA (UICC TNM Classification 7th edition)
3) Proven EGFR gene mutation status (Exon19 deletion/ Exon21 L858R; present/ absent) (regardless of the type of determination method)
4) Complete resection* is pathologically confirmed.
*Complete resection is the surgical procedure which removes lung cancer to the R0 level.
5) The level of surgical resection is higher than lobectomy.
6) ND2a-1 or higher-level lymph node dissection or selective lymph node dissection has been conducted.
7) No other treatments except surgery have been carried out for lung cancer.
8) The age is within 20-75 years inclusive.
9) A performance status (ECOG) of 0 or 1.
10) Registration was made at 21 or more days after surgery but within 56 days after surgery.
11) The functions of the main organs are maintained, and all the criteria stated below are satisfied.
(Laboratory test values should be the most recent findings obtained within 14 days before registration, although the findings made 2 weeks previously are acceptable, if they were obtained on the same day of the week as that of the date of registration.)
* Hemoglobin: >=9.0 g/dl
* WBC: >=3000/mm3 (Neutrophil count: >=1500/mm3)
* Platelet count: >=100,000/mm3
* Both AST and ALT: <=100 IU/L
* Total bilirubin: <=1.5 mg/dl
* Serum creatinine: <=1.5 mg/dl
* Creatinine clearance: >=60 ml/min (actual measurement or the value obtained using the Cockcroft-Gault formula)
12) PaO2: >=70 Torr or SpO2: >=95% in the state of no oxygen inhalation (room climate)
13) Submission of written informed consent concerning study participation.

Exclude criteria

1) Have active double cancer (synchronous double cancer and metachronous double cancer within a 5-year disease-free interval are defined as active double cancer; in situ uterocervical carcinoma judged to be curable by topical therapy, gastric/colorectal cancer resectable by endoscopy, and topically resectable active skin diseases, except malignant melanoma, are not included in active double cancer); however, a patient is eligible even if double primary NSCLC is observed in the resected lung.
2) Previously treated with cisplatin, pemetrexed or vinorelbine
3) Administration of folic acid or Vitamin B12 is not possible.
4) Serious post-operative complications (post-operative infections, suture failures, etc.)
5) Interstitial shadow considered to be clearly indicative of interstitial pneumonia on chest CT
6) Active infection
7) Requirement of continuous systemic administration (oral or intravenous) of steroid at a dose > 10 mg/day in the case of prednisolone, and the current use of an immunosuppressant; however, patients currently treated with oral steroid at a dose of 10 mg/day in case of prednisolone can be enrolled in the study.
8) Women who are currently pregnant or will not be compliant with a medically approved contraceptive regimen during and for 6 months after the treatment period and lactating women.
Men who will not be compliant with a contraceptive regimen during and for 6 months after the treatment period.
9) History of serious drug hypersensitivity
10) Other serious complications
11) Others judged by the investigator to be unsuitable for the study

Related Information

• Primary Sponsor: Takahashi Toshiaki
• Secondary Sponsor: Tsuboi Masahiro
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare,Japan Agency for Medical Research and Development,Nationcal Cancer Center Japan
• Secondary ID(s): UMIN000006737