Clinical trial · Interventional
Concurrent EGFR-TKIs and Thoracic Radiation Therapy in Active EGFR Mutation for 1st Line Treatment of Stage IV NSCLC
Concurrent EGFR-TKIs and Thoracic Radiation Therapy in EGFR Active Mutation for the First Line Treatment of Non-Small Cell Lung Cancer at Stage IV: A Single-arm, Open-label, Single Center, Phase II Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): too slow of recruitmentc
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EGFR-TKIs | Drug | — | UNRESOLVED |
| thoracic radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EGFR-TKIs combined with radiotherapy
- description
- EGFR-TKIs combined with concurrent thoracic radiotherapy. Receive oral erlotinib 150mg per day with concurrent thoracic radiotherapy, within 2 weeks, pGTV54~60Gy/27~30f/5.5~6w.
- interventionNames
- Drug: EGFR-TKIs
- Radiation: thoracic radiotherapy
Primary outcomes (1)
- measure
- 1-year rate of progression-free survival
- timeFrame
- one year after treatment, followed
- description
- 1-year rate of progression-free survival
Secondary outcomes (6)
- measure
- Overall survival (OS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDZheng L, Wang Y, Xu Z, Yang Q, Zhu G, Liao XY, Chen X, Zhu B, Duan Y, Sun J. Concurrent EGFR-TKI and Thoracic Radiotherapy as First-Line Treatment for Stage IV Non-Small Cell Lung Cancer Harboring EGFR Active Mutations. Oncologist. 2019 Aug;24(8):1031-e612. doi: 10.1634/theoncologist.2019-0285. Epub 2019 Apr 30. PMID 31040256