Radiotherapy Combined With Iressa for EGFR Mutation Positive Patients With Locally Advanced Non-small Cell Lung Cancer (NSCLC)

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Other: Gefitinib

• Registration Number: NCT01391260
• Lead Sponsor: ZhuGuangYing

Brief Summary

The purpose of this study is to access the effect and safety of radiotherapy combined whth Iressa for patients with locally advanced non-small cell lung cancer with harboring active EGFR mutations.

Detailed Description

Worldwide more than half a million new cases of lung cancer are diagnosed annually. About 80% of these tumours are of non-small cell histological type. Surgery is the treatment of choice, but only about 20% of tumours are suitable for potentially curative resection. Concurrent chemoradiotherapy is the standard treatment for locally advanced NSCLC. When Iressa was used in the first-line treatment of advanced NSCLC with EGFR mutations positive, the 12-month rates of progression-free survival were 24.9%. Therefore, we speculate that the EGFR mutations in patients with locally advanced NSCLC, Gefitinib combined with radiotherapy may be better than chemoradiotherapy. We design the study to access the effect and safety of radiotherapy combined whth Iressa for patients with locally advanced non-small cell lung cancer with harboring active EGFR mutations.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-07
• Study First Submitted QC: 2011-07-08
• Study First Posted: 2011-07-11
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-01
• Last Update Posted: 2011-08-02
• Primary Completion: 2012-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Histologically confirmed diagnosis of non-squamous NSCLC; Stage ⅢA-ⅢB(not suitable for surgery) or stage Ⅳ(only single-site single transfer );
• Untreated patients, or who completed ≤ 2 cycles of first-line chemotherapy (chemotherapy regimen: paclitaxel, docetaxel + cisplatin) within the previous month;
• Patients with tumor EGFR mutation positive (exon 19 deletion mutation or exon 21 L858R substitution mutation);
• Patients must be informed of the investigational nature of the study and must sign an informed consent form;
• Presence of at least one measurable/evaluable according to RECIST criteria.
• ECOG performance Status 0-2 ;
• Patients must have a life expectancy > 12 weeks;
• Patients with laboratory values as follows:WBC>4.0 x 109/L; ANC≥1.5 x 109/L; PLT≥100 x 109/L; HGB≥10 g/dL; CR≤1.5 x ULN; TBIL<1.5 x ULN; AST and ALT≤1.5 x ULN; LDH≤1.5 x ULN; AKP≤5 x ULN;
• FEV 1≥1.0L and >50% Corresponding normal values;
• Patient candidate to standard platinum-based chemotherapy;
• Patients must be nonpregnant and non-lactating.Patients of childbearing potential must implement an effective method of contraception during the study. All female Patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test.

Exclusion Criteria

• Any evidence of clinically active interstitial lung disease;
• Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uterine and squamous cell carcinoma of the skin；
• Pregnancy or lactating；
• Serious concomitant infection;
• MI within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia;
• As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease);
• Patients who are not suitable to participate in the trial according to researchers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiotherapy Combined With Gefitinib	Gefitinib	-

Primary Outcome Measures

Name	Time	Method
Response rate (RR)	1 year

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	2 years
Progression free survival (PFS)	2 years
Quality of life (MD-Anderson questionnaire)	1 year

Trial Locations

Locations (6)

307 Hosptial of PLA; 🇨🇳 Beijing, Beijing, China

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China

Chinese Academy of Medical Sciences Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Renmin Hospital of Wuhan University, Hubei General Hospital; 🇨🇳 Wuhan, Hubei, China

Beijing Cancer Hospital; 🇨🇳 Beijing, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China