Back to resultsGefitinib Combine Radiotherapy as Therapy for Patients With NSCLC Harbouring Sensitive Mutations of EGFR
Primary Purpose
Lung Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Gefitinib
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- China-Japan Friendship Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gefitinib + Radiotherapy
Arm Description
Experimental: Gefitinib Gefitinib 250 mg/day oral daily Radiotherapy Total dose 50-54Gy, divided dose 1.8-2Gy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall survival
evaluated in the 6 years since treatment begain
3 yeas DFS rate
To compare the adjuvant treatment arm in terms of 3 yeas DFS rate.
5 years DFS rate
To compare the adjuvant treatment arm in terms of 5 years DFS rate.
5 years OS rate
To compare the adjuvant treatment arm in terms of 5 years OS rate.
Number of Participants with Adverse Events
The safety and tolerability profile of gefitinib at a 250 mg daily dose relative to that of radiotherapy.
Full Information
NCT ID
NCT03381430
First Posted
November 15, 2017
Last Updated
December 17, 2017
Sponsor
Qilu Pharmaceutical Co., Ltd.
Collaborators
China-Japan Friendship Hospital, Peking University Cancer Hospital & Institute, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03381430
Brief Title
Gefitinib Combine Radiotherapy as Therapy for Patients With NSCLC Harbouring Sensitive Mutations of EGFR
Official Title
A Open-label, One-arm Trial of Gefitinib Combined With Radiotherapy as Adjuvant Therapy in Completely Resected Patients With Pathological Stage IIIA-N2 Non-small Cell Lung Cancer Harbouring Sensitive Mutations of EGFR
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2018 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Pharmaceutical Co., Ltd.
Collaborators
China-Japan Friendship Hospital, Peking University Cancer Hospital & Institute, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Cisplatin-based adjuvant chemotherapy is standard of care for patients with stage II-IIIA non-small cell lung cancer (NSCLC). Activating somatic mutations of the tyrosine kinase domain of epidermal growth factor receptor (EGFR) have been characterized in a subset of patients with advanced NSCLC. The recently study of gefitinib (G) versus vinorelbine+cisplatin (VP) as adjuvant treatment in stage II-IIIA (N1-N2) NSCLC with EGFR-activating mutation (ADJUVANT)shows that G had significantly longer median DFS (28.7 months) than VP (18.0months). 3-year DFS was significantly better with G (34.0% vs 27.0%; p= 0.013) and subgroup analysis of patients treated with G, lymph node status (pN1/N2) demonstrated significant correlation with DFS.
At present, postoperative radiotherapy has been widely used in the treatment of all kinds of cancer, and the guidelines also recommend postoperative radiotherapy for stage IIIA-pN2 NSCLC. The retrospective study of Lee et. al. reported on the use of postoperative radiotherapy (PORT) as first strategy after resection of stage IIIA-pN2 NSCLC. The result showed that the five-year overall OS was significantly higher in patients treated with PORT and postoperative chemotherapy (POCT) than in patients treated with PORT alone. This open-label phase II trial is studying gefitinib combined with radiotherapy to see how well it works in treating patients who have undergone surgery for Pathological stage IIIA-N2 NSCLC with EGFR activating mutation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gefitinib + Radiotherapy
Arm Type
Experimental
Arm Description
Experimental: Gefitinib Gefitinib 250 mg/day oral daily Radiotherapy Total dose 50-54Gy, divided dose 1.8-2Gy
Intervention Type
Drug
Intervention Name(s)
Gefitinib
Intervention Description
Gefitinib 250 mg/day oral daily
Primary Outcome Measure Information:
Title
Disease free survival
Description
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.
Time Frame
CT scan, abdominal ultrasound every 3 months, brain MRI every 6 months, bone scan every 12 months for up to 3 years.
Secondary Outcome Measure Information:
Title
Overall survival
Description
evaluated in the 6 years since treatment begain
Time Frame
6 years
Title
3 yeas DFS rate
Description
To compare the adjuvant treatment arm in terms of 3 yeas DFS rate.
Time Frame
3 years
Title
5 years DFS rate
Description
To compare the adjuvant treatment arm in terms of 5 years DFS rate.
Time Frame
5 years
Title
5 years OS rate
Description
To compare the adjuvant treatment arm in terms of 5 years OS rate.
Time Frame
5 years
Title
Number of Participants with Adverse Events
Description
The safety and tolerability profile of gefitinib at a 250 mg daily dose relative to that of radiotherapy.
Time Frame
In the period of Gefitinib 250 mg/day oral daily for 24 months. Radiotherapy total dose 50-54Gy, divided dose 1.8-2Gy.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guang-ying Zhu, MD
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
Gefitinib Combine Radiotherapy as Therapy for Patients With NSCLC Harbouring Sensitive Mutations of EGFR
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