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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 10, 2020

Interventions

  • Radiation: SBRT+TKI
    • Received SBRT after three months after EGFR-TKI treatment
  • Drug: TKI
    • Received EGFR-TKI treatment

Arms, Groups and Cohorts

  • Experimental: SBRT+TKI
    • SBRT with photon and dose is 40-50Gy/5F after three months after EGFR-TKI treatment
  • Active Comparator: TKI
    • Standard EGFR-TKI(Gefitinib, erlotinib or icotinib) Gefitinib: 250mg po Qd Erlotinib: 150mg po Qd Icotinib: 125mg po tid

Clinical Trial Outcome Measures

Primary Measures

  • PFS
    • Time Frame: 2 years
    • progression-free survival

Secondary Measures

  • OS
    • Time Frame: 3 year
    • overall survival

Participating in This Clinical Trial

Inclusion Criteria

1. Patients must have biopsy proven metastatic NSCLC (Stage IV).

2. Patients must have received first line chemotherapy, from 4-6 cycles, and achieved stable disease or a partial response.

3. Patients receiving first-line erlotinib, gefitinib, or icotinib for EGFR mutant-positive for 3 months and achieved stable disease, partial response or completely response.

4. Age 18 to 75 years old.

5. Patients must have measurable disease at baseline.

6. The amount of metastatic focus <5.

7. ECOG score 0-2

8. Adequate normal organ and marrow function for TKI treatment and radiotherapy.

9. Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R)

10. Patients must provide written informed consent to participate in the study.

Exclusion Criteria

1. Patients who previously received radiotherapy to the primary site.

2. Patient can't tolerate radiotherapy or targeted therapy;

3. Pregnant or nursing women

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tongji Hospital
  • Collaborator
    • Wuhan Union Hospital, China
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • li Zhang, MD,PhD, Principal Investigator, Tongji Hospital
  • Overall Contact(s)
    • li Zhang, MD,PhD, 02783663407, luzigang@163.com

References

Iyengar P, Wardak Z, Gerber DE, Tumati V, Ahn C, Hughes RS, Dowell JE, Cheedella N, Nedzi L, Westover KD, Pulipparacharuvil S, Choy H, Timmerman RD. Consolidative Radiotherapy for Limited Metastatic Non-Small-Cell Lung Cancer: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2018 Jan 11;4(1):e173501. doi: 10.1001/jamaoncol.2017.3501. Epub 2018 Jan 11.

Gomez DR, Blumenschein GR Jr, Lee JJ, Hernandez M, Ye R, Camidge DR, Doebele RC, Skoulidis F, Gaspar LE, Gibbons DL, Karam JA, Kavanagh BD, Tang C, Komaki R, Louie AV, Palma DA, Tsao AS, Sepesi B, William WN, Zhang J, Shi Q, Wang XS, Swisher SG, Heymach JV. Local consolidative therapy versus maintenance therapy or observation for patients with oligometastatic non-small-cell lung cancer without progression after first-line systemic therapy: a multicentre, randomised, controlled, phase 2 study. Lancet Oncol. 2016 Dec;17(12):1672-1682. doi: 10.1016/S1470-2045(16)30532-0. Epub 2016 Oct 24.

de Vin T, Engels B, Gevaert T, Storme G, De Ridder M. Stereotactic radiotherapy for oligometastatic cancer: a prognostic model for survival. Ann Oncol. 2014 Feb;25(2):467-71. doi: 10.1093/annonc/mdt537. Epub 2013 Dec 18.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.