TKI Followed by Thoracic Radiotherapy for Stage IV EGFR Mutant NSCLC

Non-Small Cell Lung Cancer Metastatic Clinical Trial

Official title:

Tyrosine Kinase Inhibitor Followed by Thoracic Radiotherapy for Stage IV EGFR Mutant Non-small Cell Lung Cancer: A Phase II Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03916913
• Other study ID #: NCC201805002
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 1, 2023

Study information

• Verified date: April 2019
• Source: Chinese Academy of Medical Sciences
• Contact: Jingbo Wang, MD
• Phone: +861087788056
• Email: wangjingbo303[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this phase II trial with single arm, we aim to investigate the clinical efficacy and toxicity profile of local radiotherapy on all disease sites for EGFR-mutant oligo-metastatic NSCLC (no more than 3 metastatic lesions) who did not experience disease progression after at least 3 months of TKI therapy.

Description:

Tyrosine kinase inhibitor (TKI) has been widely accepted as the first-line therapy for stage IV NSCLC with active mutation of EGFR. Olio-metastasis is a disease status between localized and extended status of disease, namely with the limited number of lesions, which is generally defined as ≤ 5. A couple of phase II studies have shown that consolidation local management was able to prolong the local-regional tumor control and might further improve overall survival (OS) for oligo-metastatic NSCLC who have gained disease control from systemic therapy. However, there is lack of data regarding whether local radiotherapy (RT) could improve progression free survival (PFS) and OS for NSCLC with active EGFR mutation who have benefited from TKI. In this phase II trial with single arm, we aim to investigate the clinical efficacy and toxicity profile of local radiotherapy on all disease sites for EGFR-mutant oligo-metastatic NSCLC (no more than 3 metastatic lesions) who did not experience disease progression after at least 3 months of TKI therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age =18 and =75;

• ECOG performance status 0-1;

• Patients must provide study specific informed consent prior to study entry;

• Pathologically or cytologically diagnosed as NSCLC;

• EGFR activating mutation to TKI approved by histology, cytology or circulation tumor DNA;

• Stage IV NSCLC with = 3 metastatic lesions (AJCC, 8th ed.) confirmed by meticulous radiographic examination. Brain MRI and 18F PET/CT is strongly recommended unless there is a contraindication;

• Patients have received=3 months of TKI therapy and do not received disease progression;

• HB = 10.0 g/dL;

• Absolute number of neutrophil granulocyte = 1.5 × 109/L;

• Absolute number of PLT = 100 × 109/L;

• Total bilirubin = 1.5 folds of the maximum extent;

• ALT and AST = 2.0 folds of the maximum extent;

• Cr = 1.25 folds of the maximum extent and Ccr = 60mLl/min.

Exclusion Criteria:

• Patients have received thoracic radiotherapy before;

• Malignant pleural effusion, pericardial effusion or peritoneal effusion;

• Patients have severe pulmonary comorbidity, such as ILD, COPD or other active pulmonary disease;

• Any unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, CHF (NYHA = II), MI within 6 months of enrollment, severe arrhythmia requiring medication,hepatic, nephric or metabolic disease;

• HIV infection;

• Pregnancy or lactation women;

• ECOG status =2;

• Mixed SCLC component;

• Other factors that is considered ineligible.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer Metastatic

Intervention

Radiation:
• Local radiation therapy
Local radiotherapy on all sites of disease including primary and metastatic lesions

Locations

Country	Name	City	State
China	Cancer Hospital/Institute, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	Duration between the first date of TKI administration and disease progression or last follow-up	1 year
Secondary	Overall response	Post-RT response compared with the baseline status at the first data of TKI administration	1 month after RT
Secondary	Overall survival	Duration between the first date of TKI administration and any cause of death or last follow up	2 year
Secondary	Time to progression of initial lesions	Duration between the first date of TKI administration and the progression of the initial lesions or last follow up	1 year
Secondary	Time to appearance of new metastatic lesions	Duration between the first date of TKI administration and the occurrence of new lesions or last follow up	1 year
Secondary	Treatment related toxicity	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0	1 year
Secondary	EORTC Quality of life	Quality of life evaluation using EORTC questionnaires	1 year