TKI Followed by Thoracic Radiotherapy for Stage IV EGFR Mutant NSCLC

  • STATUS
    Recruiting
  • End date
    Jan 1, 2023
  • participants needed
    85
  • sponsor
    Chinese Academy of Medical Sciences
Updated on 3 February 2022
EGFR

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.

Details
Condition Non-Small Cell Lung Cancer Metastatic
Treatment Local radiation therapy
Clinical Study IdentifierNCT03916913
SponsorChinese Academy of Medical Sciences
Last Modified on3 February 2022

Eligibility

Yes No Not Sure

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 received3 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 medicationhepatic, nephric or metabolic disease
HIV infection
Pregnancy or lactation women
ECOG status 2
Mixed SCLC component
Other factors that is considered ineligible
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