Concurrent EGFR-TKIs and Thoracic Radiation Therapy in Active EGFR Mutation for 1st Line Treatment of Stage IV NSCLC

• Status: Terminated
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This single-arm phase II study aims to study the efficacy of a possible first line treatment that combines epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKIs) with concurrent thoracic radiation therapy for stage IV non-small cell lung cancer (NSCLC) with active EGFR mutation, as well as assessing PFS, OS, tumor response, etc. to verify that this new combinational therapy can benefit short-term and long-term survival of the patients with advanced NSCLC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xinqiao Hospital of Chongqing

Criteria

Inclusion Criteria:

1. ECOG performance status≤2；

2. Cytologically or pathologically confirmed stage IV NSCLC ( controlled pleural effusion will be eligible) with active EGFR mutation;

3. Estimated survival time more than 3 months;

4. Age older than 18 years and under 75 years;

5. Adequate bone marrow, hepatic, and renal function;AST and ALT≤2.5 times the highest reference value when not associated with hepatic metastases, or ≤5 times when hepatic metastases occur;

6. Without history of therapy for primary and metastatic disease;

7. With pleural effusion but can be controlled;

8. Asymptomatic bone metastases without treatment;

9. Based on fusion images of 4DCT MIP sketch tumors and lymph nodes, and limit the mean lung dose: V20≤25%，V30≤18%，MLD≤14Gy，V5≤60%;

10. M1a or M1b for metastases, and the number of the distant lesions ≤10；

11. Voluntary to participate in this clinical trial and sign the consent form.

Exclusion Criteria:

1. Patients with serious functional damage of important organs;

2. Patients diagnosed adequately with other malignant tumors;

3. Pregnant or lactating women;

4. Patients in an active period of acute or chronic infectious diseases;

5. Patients who are allergic to any drugs or people with allergies;

6. With brain metastases;

7. With bone metastases needing radiotherapy;

8. Patients who participate in other clinical trials concurrently;

9. Uncontrolled pleural effusion which may intervene the radiotherapy to primary tumor in lung;

10. The number of the distant lesions>10；

11. Patients who are considered not eligible for the trial after evaluation by investigator.