Phase II study of 4-drug combination chemotherapy in patients with non-small cell lung cancer harboring EGFR active mutation.

JRCT ID: jRCTs031180157

Registered date:25/02/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 17/11/2017
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Four-drug combination chemotherapy of carboplatin, pemetrexed, bevacizumab and erlotinib

Outcome(s)

• Primary Outcome: Progression-free survival
• Secondary Outcome: Overall Response rate, Disease Control Rate, Overall Survival, Safety profiles

Key inclusion & exclusion criteria

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

Include criteria

1, histologically or cytologically confirmed non-squamous non-small cell lung cancer
2, Stage IIIB, IIIC, IVA and IVB without indication of curative therapy or postoperative recurrent condition (UICC 8th)
3, EGFR active mutation i.e. exon 19 deletion or exon 21 L858R point mutation (a patient with complex mutations is excluded except for the combination of exon 19 deletion and exon 21 L858R point mutation)
4, One or more mesurable lesion(s)
5, chemotherapy-naive patient
6, Aged 20 or older at the time of informed consent
7, Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1
8, Adequate oral intake
9, Adequate organ function
10, All of the following criteria are met based on the latest data obtained within 14 days before enrollment:
1) Neutrophil count >= 1,500/mm^3
2) Hemoglobin >= 9.0 g/dL
3) Platelet count >= 10*10^4/mm^3
4) Total bilirubin <= 1.5 mg/dL (<= 2.0 mg/dl in case liver metastases is present)
5) AST(GOT) <= 2.5 X ULN and ALT(GPT) <= 2.5 X ULN (<= 5.0 X ULN if liver metastases is present)
6) Creatinine <= 1.5 X ULN
7) SpO2 >= 95% in room air or PaO2 is 80 torr or more.
8) Urinary protein is 1+ or less.
11, At the time of registration, the following period should elapse since the end of the following prior treatment:
Palliative radiation therapy: 2 weeks or more.
Surgical therapy (including examination or exploratory thoracotomy): 4 weeks or more.
Thoracic / cardiac drainage therapy: 2 weeks or more.
12, Estimated life expectancy should be more than 90 days from the date of registration.
13, Have given written consent to participate in the study after receiving detailed explanation of the study.

Exclude criteria

1, Evident pulmonary fibrosis or interstitial lung disease on chest X-ray
2, History of radiotherapy for primary lesion (Eligible if primary lesion is out of radiation field)
3, Presence or past history of hemoptysis (>= 2.5 ml)
4, Predisposing factor of airway bleeding i.e. disorder of coagulation, tumor invasion to major vessels, evident cavitary lesions, and tumor invasion of bronchus mucosa
5, Symptomatic central nervous system metastases (Eligible if central nervous system symptoms are not observed after stereotactic radiotherapy such as gamma knife and two weeks should elapse after last irradiation. Registration after whole brain radiation is not permitted regardless of the presence of CNS symptoms.)
6, Active infectious disease (excluding viral hepatitis)
7, Severe complication (congestive heart failure, chronic renal failure, chronic liver failure, bleeding peptic ulcer, paralysis of intestine, ileus, uncontrollable diabetes mellitus, and so on)
8, Ascites or pleural effusion requiring drainage
9, Active double cancer
10, Elective surgery after enrollment of the study
11, Pregnant or lactating females, females of child-bearing potential, and males desiring partner's pregnancy
12, Severe mental disorder
13, Severe drug hypersensitivity
14, Active hepatic disease
15, Any other condition unsuitable for enrolling the study judged by the attending doctor

Related Information

• Primary Sponsor: Kurata Takayasu
• Secondary Sponsor: North East Japan Study Group (NEJSG)