NEJ025B

JRCT ID: jRCTs021200005

Registered date:19/05/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Non-sequamous non-small cell lung cancer
• Date of first enrollment: 07/06/2020
• Target sample size: 35
• Study type: Interventional

Intervention(s)

Induction therapy: carboplatin AUC 5 day1+ pemetrexed 500 mg/m2 day1 q3w 4 cycles and afatinib 20 mg/body every day.
Maintenance therapy: pemetrexed 500 mg/m2 day1 q3w and afatinib 20 mg/body every day until PD.

Outcome(s)

• Primary Outcome: Progression-Free Survival Rate at 6 months
• Secondary Outcome: Overall Survival,Progression-Free Survival,Objective Response Rate,Duration Of Response,Safety,Difference of efficacy of study treatment among EGFR mutation types,Biomarker analyses

Key inclusion & exclusion criteria

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

Include criteria

1)A histologically or cytologically confirmed diagnosis of non-small-cell lung cancer other than squamous cell carcinoma.
2)Have clinical stage IIIB, IIIC, IVA, IVB or postoperative recurrent non-small-cell lung cancer that cannot be treated with radical radiotherapy and surgery.
3)An observed Exon 19 deletion mutation or Exon 21 L858R mutation in tumor tissue or tumor cells before osimertinib treatment.
4)They have 1 or more measurable lesions based on the criteria in Response Evaluation Criteria in Solid Tumors (RECIST)Version 1.1 after failure of osimertinib.
5)Confirmed PD of previous osimertinib treatment as a first-line treatment. Regardless of treatment duration of osimertinib.
6)Recovering from adverse effect until grade1 or less.
7) Be a case where chemotherapy or immunotherapy has not yet been carried out, excluding neoadjuvant and adjuvant chemotherapy 6 months before enrollment and pleurodesis a week before enrollment.
8)Be aged 20 years or over at the time of consent acquisition.
9)Have an ECOG performance status (PS) of 0 to 1.
10)Main organ functions must meet the following criteria within two weeks prior to enrollment. If there are multiple test results within this period, then the most recent test prior to enrollment will be adopted.
1) Neutrophil count 1,500/mm3 or above
2)Lymphocyte count 500/mm3 or above
3)Hemoglobin 9.0 g/dL or above
4)Platelet count 10.0 x104/mm3 or above
5)AST 2.5 times the upper limit of the site's standard values or below
6)ALT 2.5 times the upper limit of the site's standard values or below
7)Total bilirubin 1.5 times the upper limit of the site's standard values or below
8)Serum creatinine 1.5 times the upper limit of the site's standard values or below
9)Creatinine Clearance 45 mL/min or above
10) PaO2 (room air) 70 Torr or above, or SpO2 93% or above
11) The details of this study were sufficiently explained to the patient and written consent was obtained from the patient them self.

Exclude criteria

1)Have active interstitial lung disease, or a history of drug-induced pneumonitis, radiation pneumonitis needing steroid treatment.
2)The patient has brain metastasis that requires anti-edema drugs such as steroids for symptomatic brain metastases or symptom management and meningitis carcinomatosa.
*Asymptomatic brain metastasis is not excluded.
3) Have a history of irradiation directed at the lesions in the lung field or other target lesion.
*Enrollment is permitted in cases which have had palliative irradiation for bone lesions in the chest, if at the time of enrollment 2 weeks or more have elapsed since the final day of irradiation.
4) Currently have serious complications including uncontrolled lung, liver, and renal disease.
5)Have heart disease that could be clinically problematic (such as uncontrollable hypertension, unstable angina, congestive heart failure, advanced arrhythmia requiring treatment with medication, or a history of myocardial Infarction within 12 months prior to enrollment).
* treatment of hypertension is eligible.
6) Currently have or have a history of the following serious complications:
-Also have superior vena cava syndrome.
-Have spinal cord compression.
-Also have symptomatic cerebrovascular disease or have a history of cerebrovascular disease within 3 months before enrollment.
-Have unhealed bone fractures (excluding the like associated with osteoporosis) or advanced wounds
-Have infectious diseases requiring systemic administration of antibiotics, antifungal agents or antiviral agents.
7) Have uncontrolled gastrointestinal disturbances affecting intestinal absorption of afatinib (such as Crohn's disease, ulcerative colitis, chronic diarrhea, and malabsorption).
8)Have an active hepatitis being positive for HBV DNA* and HIV infection.
*Measure HBV DNA if the patient is positive for HBs antigens, HBs antibodies or HBc antibodies
9) Women who are currently pregnant or breastfeeding. Or women who are capable of becoming pregnant. Men who want to partner's pregnancy.
10) Be undergoing systemic administration of steroids for 4 weeks or more (however, enrollment is permitted for steroids in terms of within prednisolone 10 mg/day).
11)Have pleural effusion, ascites or pericardial effusion that require drainage (enrollment is permitted if the symptoms stabilize a week after drainage).
12) Have contraindication to afatinib, carboplatin, or pemetrexed.
13) The patient has complications with double cancers that have a disease-free period of less than 5 years (enrollment is permitted if intraepithelial carcinoma and intramucosal carcinoma lesions have been judged as cured from localized treatment regardless of the disease-free period).
14) Have significant neuropathy or psychosis (includes dementia and epileptic seizures).
15) Surgery is planning during study period.
16) Have serious hypersensitivity to afatinib, carboplatin, or pemetrexed.
17) Individuals who are deemed to be unsuitable for participation in this study by the principal investigator or sub-investigators for any other reason.

Related Information

• Primary Sponsor: Maemondo Makoto
• Source(s) of Monetary Support: Boehringer Ingelheim Japan, Inc.