Skip to main content
OpenTrials
Completed

NCT Number: NCT03595644

Maintenance Targeted Therapy With or Without Stereotactic Body Radiation Therapy for Stage IV Non-small Cell Lung Cancer

This is a Prospective, Multicenter, Randomized Controlled study to evaluate Stereotactic Body Radiation Therapy (SBRT) as a potential treatment for stage IV non-small cell lung cancer (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) and has been receiving treatment with a targeted agent such as gefitinib, erlotinib and icotinib.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stage IV Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must have biopsy proven metastatic NSCLC (Stage IV).
  • Patients must have received first line chemotherapy, from 4-6 cycles, and achieved stable disease or a partial response.
  • Patients receiving first-line erlotinib, gefitinib, or icotinib for EGFR mutant-positive for 3 months and achieved stable disease, partial response or completely response.
  • Age 18 to 75 years old.
  • Patients must have measurable disease at baseline.
  • The amount of metastatic focus <5.
  • ECOG score 0-2
  • Adequate normal organ and marrow function for TKI treatment and radiotherapy.
  • Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R)
  • Patients must provide written informed consent to participate in the study.

Exclusion criteria

  • Patients who previously received radiotherapy to the primary site.
  • Patient can't tolerate radiotherapy or targeted therapy;
  • Pregnant or nursing women

Treatment and study plan

SBRT+TKI

Radiation

Received SBRT after three months after EGFR-TKI treatment

TKI

Drug

Received EGFR-TKI treatment

Primary outcomes

  1. PFS

    Time frame: 2 years

    Progression-free survival: From the first treatment to the date of first documentation of disease progression, or death due to any cause

Secondary outcomes

  1. OS

    Time frame: 3 year

    Overall survival: From the first administration to death from any cause

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Collaborators

  • Hubei Cancer Hospital
  • Renmin Hospital of Wuhan University
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Wuhan University

Registry information

Official study title

Maintenance Targeted Therapy With or Without Stereotactic Body Radiation Therapy for Stage IV Non-small Cell Lung Cancer: a Prospective, Multicenter, Randomized Controlled Clinical Trial.

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jul 23, 2018
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.