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

NCT03457337 | Unknown Phase 2 DMC

• 1 other identifier: NA-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 gefitinib monotherapy

Conditions

Advanced NSCLC With EGFR Mutation

Outcome Measures

Primary Outcomes (1)

• Progression free survival(PFS)

  From start of anti-cancer therapy until progression or death.To evaluate the disease free survival of gefitinib combined with S-1 and gefitinib in patients with Pathological stage IIIc-IV NSCLC harbouring sensitive mutations of EGFR. Progression free survival (PFS)- defined as the time from initial medication to the first documented disease progression or death, whichever occurs first.

  2 years

Secondary Outcomes (4)

• Overall survival(OS)

  3 years

• Disease control rate

  2 years

• Objective response rate(ORR)

  2 years

• Number of Participants with Adverse Events

  3 years

Other Outcomes (1)

• Assessment of Health-related quality of life

  3 years

Study Arms (2)

S-1 plus Gefitinib

EXPERIMENTAL

S-1: According to the body surface area (BSA) to determine the dose, twice daily, after breakfast and dinner orally, continuous administration of 14 days, rest for 7 days. BSA \<1.25 m2, 80 mg / day; BSA 1.25 m2 to \<1.5 m2, 100 mg / day; BSA 1.5 m2 or more, 120 mg / day. Until disease progression, intolerance of toxicity or withdrawal of informed consent from the subject. Gefitinib: 250mg, 1 day, orally, fasting or with the same service. Until disease progression, intolerance of toxicity or withdrawal of informed consent from the subject.

Drug: S-1 plus Gefitinib

Gefitinib

ACTIVE COMPARATOR

Gefitinib 250 mg/day oral daily

Drug: Gefitinib

Interventions

S-1 plus Gefitinib DRUG

S-1: According to the body surface area (BSA) to determine the dose, twice daily, after breakfast and dinner orally Gefitinib: 250mg, 1 day, orally, fasting or with the same service

S-1 plus Gefitinib

Gefitinib DRUG

Gefitinib: 250mg, 1 day, orally

Gefitinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Interventions

S 1 (combination); Gefitinib

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Qiming Wang, Ph.D

CONTACT

0086+13783590691; qimingwang1006@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 7, 2018
• Study Start: March 28, 2018
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2021
• Last Updated: July 10, 2020

Record last verified: 2020-04

Locations

CN (1)