Gefitinib Combine Radiotherapy as Therapy for Patients With NSCLC Harbouring Sensitive Mutations of EGFR

NCT03381430 | Unknown

• 1 other identifier: GRAY
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the survival benefit of the gefitinib combined with radiotherapy as adjuvant therapy for completely resected patients with Pathological stage IIIA-N2 NSCLC harbouring sensitive mutations of EGFR.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  From start of anti-cancer therapy until progression or death. To evaluate the disease free survival of gefitinib combined with radiotherapy as adjuvant therapy in completely resected patients with Pathological stage IIIA-pN2 NSCLC harbouring sensitive mutations of EGFR.Disease free survival (DFS)- defined as the time from initial medication to the first documented disease progression or death, whichever occurs first.

  CT scan, abdominal ultrasound every 3 months, brain MRI every 6 months, bone scan every 12 months for up to 3 years.

Secondary Outcomes (5)

• Overall survival

  6 years

• 3 yeas DFS rate

  3 years

• 5 years DFS rate

  5 years

• 5 years OS rate

  5 years

• Number of Participants with Adverse Events

  In the period of Gefitinib 250 mg/day oral daily for 24 months. Radiotherapy total dose 50-54Gy, divided dose 1.8-2Gy.

Study Arms (1)

Gefitinib + Radiotherapy

EXPERIMENTAL

Experimental: Gefitinib Gefitinib 250 mg/day oral daily Radiotherapy Total dose 50-54Gy, divided dose 1.8-2Gy

Drug: Gefitinib

Interventions

Gefitinib DRUG

Gefitinib 250 mg/day oral daily

Gefitinib + Radiotherapy

Eligibility Criteria

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

You may qualify if:

• Written informed consent provided.
• Males or females aged ≥18 years, \< 75 years.
• Target population is completely resected pathological stage IIIA-N2 NSCLC with EGFR exon 19 deletions and exon 21 L858R activating mutation.
• Underwent radical resection
• The patient did not receive any neoadjuvant chemotherapy or EGFR-TKI targeted therapy before surgery
• Patient who can start the investigational therapy within 3-6 weeks after the complete resection
• ECOG performance status 0-1.
• Life expectancy ≥12 weeks.
• Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
• Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
• Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.
• Female subjects should not be pregnant or breast-feeding.

You may not qualify if:

• Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
• Patients with prior any systemic chemotherapy, immunotherapy or biotherapy
• Known severe hypersensitivity to gefitinib or any of the excipients of this product.
• Patients with prior radiotherapy.
• Not fully recovered from the previous surgery.
• History of another malignancy in the last 5 years with the exception of the following: basal cell carcinoma of the skin and in situ carcinoma of the uterine cervix.
• Patients who harbouring exon 20 T790M mutation.
• Patient who has any active infection (e.g. acute pneumonia, hepatitis B or hepatitis C).
• Dysphagia or known malabsorption of drugs.
• Patient with serious heart, liver, kidney or other important organ dysfunction.
• Pregnancy or lactation women or women may be positive for pregnancy before the first medication.
• Patient has fertility but not willing to take contraceptive measures or whose sexual partners are unwilling to take contraceptive measures.
• Researcher believes the patient's condition is not suitable for the clinical study.
• Researcher judged the patient's lack of compliance with the study.
• Known severe hypersensitivity to gefitinib or any of the excipients of this product.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead
• China-Japan Friendship Hospital: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• Chinese PLA General Hospital: collaborator

Study Sites (1)

China-Japan Friendship Hospital

Beijing, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Guang-ying Zhu, MD

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: December 22, 2017
• Study Start: June 1, 2018
• Primary Completion: March 1, 2023
• Study Completion: December 1, 2025
• Last Updated: December 22, 2017

Record last verified: 2017-11

Locations

CN (1)