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

• ClinicalTrials.gov Identifier: NCT03595644
• Recruitment Status: Completed
• First Posted: July 23, 2018
• Last Update Posted: April 8, 2021
• Sponsor: Tongji Hospital
• Collaborators: Wuhan Union Hospital, China; Renmin Hospital of Wuhan University; Wuhan University; Hubei Cancer Hospital
• Information provided by (Responsible Party): Tongji Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Stage IV Non-small Cell Lung Cancer	Radiation: SBRT+TKI; Drug: TKI	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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.
• Actual Study Start Date: February 12, 2017
• Actual Primary Completion Date: June 10, 2019
• Actual Study Completion Date: December 10, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. OS [ Time Frame: 3 year ]
   Overall survival: From the first administration to death from any cause

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

China, Hubei

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

Wuhan, Hubei, China, 430030

Sponsors and Collaborators

Tongji Hospital

Wuhan Union Hospital, China

Renmin Hospital of Wuhan University

Wuhan University

Hubei Cancer Hospital

Investigators

• Principal Investigator: li Zhang, MD,PhD; Tongji Hospital

More Information

Publications:

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.

• Responsible Party: Tongji Hospital
• ClinicalTrials.gov Identifier: NCT03595644
• Other Study ID Numbers: TJCC-LC001
• First Posted: July 23, 2018
• Last Update Posted: April 8, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms