Status:
UNKNOWN
S-1 Plus Gefitinib Versus Gefitinib Monotherapy in Patients With EGFR-sensitive Mutation Advanced Non-squamous NSCLC
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Advanced NSCLC With EGFR Mutation
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To investigate the survival benefit of first-line therapy for patients with EGFR-sensitive mutation-positive advanced non-squamous non-small cell lung cancer treated with S-1plus gefitinib versus gefi...
Detailed Description
This is a randomized, controlled, open-plan, prospective clinical study. According to the available evidence, we selected patients with locally advanced or metastatic non-squamous non-small cell lung ...
Eligibility Criteria
Inclusion
- Volunteered for attending the study, and signed informed consent form (ICF)to participate in the study.
- Males or females aged ≥18 years, \< 75 years.
- Cytologically and Histologically documented, advanced or recurrent (stage IIIc-IV) non-small cell lung cancer patients .
- exon 19 deletion or exon 21 L858R for EGFR mutation.
- Patients hadn't received past system treatment, including cytotoxic drugs; For patients who have received adjuvant or neoadjuvant chemotherapy appears recurrence or metastasis more than 6 months from accepting the last dose of chemotherapy drugs
- Patients must have at least 1 measurable lesion according to the RECIST (version 1.1) criteria.
- Life expectancy ≥12 weeks.
- ECOG performance status 0-2.
- Adequate organ function as defined by the following criteria:
- Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN), alkaline phosphatase (AP), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in the absence of liver metastases or up to 5 ULN in case of liver metastases.
- creatinine clearance≥ 60 ml/min.
- Fertile men and women must use effective contraception.
- Subjects are allowed to receive radiation for lesions other than the target lesion, but the end of radiotherapy should be at least 3 weeks apart from randomization;
- The investigators should judge the subject's compliance to meet the study requirements.
Exclusion
- Histology confirmed for squamous carcinomas, including mixed gland scale cancer, small cell lung cancer.
- Patients with prior any anti-tumor therapy,including chemotherapy, radiotherapy, immunotherapy or biotherapy
- Patients with prior exposure to EGFR-TKIs or 5-Fu
- Not recovered from previous toxic reactions for anticancer treatment (CTCAE grade 1) or not fully recovered from previous surgery
- Patients who have brain metastasis. It is permitted if the patient has been treated with surgery and/or radiation with evidence of stable disease for at least 4 weeks.
- Patients haven't been diagnosed other malignant disease, except the basal cell carcinoma and cervical carcinoma.
- A uncontrolled clinical infection, activity, including acute pneumonia,HIV,HCV. , etc.
- Sullivudine, brivudine or other antiviral drugs of similar structure were used within 2 months before randomization
- Patients who have a difficulty in swallowing or drug absorption.
- Patients with a history of interstitial lung disease or with interstitial lung disease;
- There are diseases of alimentary canal such as active duodenal ulcer, the ulcerous colitis, intestinal obstruction or other conditions which can cause gastrointestinal bleeding or perforation in the investigator's opinion; or patient has a history of intestinal perforation, intestinal fistula.
- Evaluation of cardiac function: left ventricular ejection fraction \< 50% (echocardiography); Moderate or above disorders of mitral valve and tricuspid shut down;, serious/unstable angina or acute myocardial infarction coronary artery bypass surgery in 6 months before enrollment; patients with class 2 and above cardiac dysfunction according to New York heart association (NYHA) classification
- Patients with medical history of hemoptysis (defined as about 2.5ml bright blood) 2 weeks before the enrollments
- Stroke and transient ischemic in 12 months before enrollment.
- Severe ulcer in the skin wound, trauma and mucosa or fractures have been not fully healed.
- Patients received CYP3A4 strong inhibitor and/or inducer in 2 weeks before enrollment; Patients received P-gp and breast cancer resistance protein (BCRP) substrates drug in 2 weeks before enrollment.
- Patients has participated in other clinical trials of antitumor drugs within the previous 28 days, except for those who were able to prove that they were using placebo;
- Pregnancy or lactating women or pregnant women may be pregnant before pregnancy test positive;
- Unwillingness to receive contraception by patients or their sexual partners who are fertile but unwilling to receive contraception;
- The investigators think that there is any clinical or laboratory abnormalities in the subjects that are not suitable for this study.
- There is a serious psychological or mental abnormalities, researchers assess subjects to participate in this clinical study compliance is insufficient;
- Allergic reactions to analogs of gefitinib and S-1 and / or Analogs and / or excipients in test drugs.
Key Trial Info
Start Date :
March 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03457337
Start Date
March 28 2018
End Date
October 31 2021
Last Update
July 10 2020
Active Locations (1)
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1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000