S-1 Plus Gefitinib Versus Gefitinib Monotherapy in Patients With EGFR-sensitive Mutation Advanced Non-squamous NSCLC

  • STATUS
    Recruiting
  • End date
    Oct 31, 2021
  • participants needed
    200
  • sponsor
    Henan Cancer Hospital
Updated on 24 January 2021

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 gefitinib monotherapy

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 cancer with stage -C- confirmed by cytology or histology and positive EGFR-sensitive mutation, then patients accept first-line treatment with S-1 plus gefitinib or gefitinib. This study will collect FFS during treatment until the patient dies and will follow the survival of the subject after the disease progresses.

Details
Condition EGFR-sensitive Mutation-positive Advanced Non-squamous Non-small Cell Lung Cancer Treated With S-1plus Gefitinib Versus Gefitinib Monotherapy, Advanced NSCLC With EGFR Mutation
Treatment Gefitinib, S-1 plus Gefitinib
Clinical Study IdentifierNCT03457337
SponsorHenan Cancer Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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