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

NCT03595644 | Completed Phase 2 DMC

• 1 other identifier: TJCC-LC001
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage IV Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

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

  2 years

Secondary Outcomes (1)

• OS

  3 year

Study Arms (2)

SBRT plus TKI group

EXPERIMENTAL

SBRT with photon and dose is 40-50Gy/5F after three months after EGFR-TKI treatment

Radiation: SBRT+TKI

TKI treatment group

ACTIVE COMPARATOR

Standard EGFR-TKI(Gefitinib, erlotinib or icotinib) Gefitinib: 250mg po Qd Erlotinib: 150mg po Qd Icotinib: 125mg po tid

Drug: TKI

Interventions

SBRT+TKI RADIATION

Received SBRT after three months after EGFR-TKI treatment

SBRT plus TKI group

TKI DRUG

Received EGFR-TKI treatment

TKI treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

Related Publications (4)

• 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.

  PMID: 28973074 BACKGROUND

• 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.

  PMID: 27789196 BACKGROUND

• 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.

  PMID: 24355488 BACKGROUND

• Peng P, Gong J, Zhang Y, Zhou S, Li Y, Han G, Meng R, Chen Y, Yang M, Shen Q, Chu Q, Xia S, Zhang P, Zhang L, Chen Y, Zhang L. EGFR-TKIs plus stereotactic body radiation therapy (SBRT) for stage IV Non-small cell lung cancer (NSCLC): A prospective, multicenter, randomized, controlled phase II study. Radiother Oncol. 2023 Jul;184:109681. doi: 10.1016/j.radonc.2023.109681. Epub 2023 Apr 25.

  PMID: 37105304 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• li Zhang, MD,PhD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 23, 2018
• Study Start: February 12, 2017
• Primary Completion: June 10, 2019
• Study Completion: December 10, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)