Real-world Treatment Patterns and Clinical Outcomes in EGFR-mutant Unresectable Locally Advanced NSCLC

Real-world Treatment Patterns and Clinical Outcomes in Epidermal Growth Factor Receptor(EGFR)-Mutant Unresectable Locally Advanced NSCLC: A Retrospective Multi-center Study

The investigators will obtain a cohort of patients from multiple large cancer centers in China and try to unravel the efficacy of "radiotherapy combined with EGFR-TKI", which may provide some evidences for the treatment of stage III-inoperable NSCLC.

Study Overview

• Status: Unknown
• Conditions: Non Small Cell Lung Cancer; Stage III Non-small-cell Lung Cancer; EGFR Mutation-Related Tumors
• Intervention / Treatment: Radiation: radiation or chemo-radiation; Drug: EGFR-TKI Inhibitor

Detailed Description

The frequency of EGFR mutations in patients with stage III inoperable adenocarcinoma or non-squamous cell carcinoma is 17-31%, which is relatively low. Compared to patients with EGFR wild type, the efficacy of radiotherapy or chemo-radiotherapy may be different in EGFR mutant patients. Some small sample studies showed, compared with patients with EGFR wild type, patients with EGFR mutations have a lower risk of local recurrence and a higher risk of distant metastasis under the standard treatment for stage III lung cancer, which demonstrate the strength of systemic therapy may help. Radiotherapy combined with EGFR-Tyrosine kinase inhibitors(TKI) is a feasible treatment strategy. In view of the low mutation frequency and few prospective research results, the investigators try to explore the survival differences of three treatment strategies used in clinical practice based on the real world data. The investigators will obtain a cohort of patients from multiple large cancer centers in China and try to unravel the efficacy of "radiotherapy combined with EGFR-TKI", which may provide some evidences for the further study.

• Study Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

• Study Contact: Name: Luhua Wang, MD; Phone Number: 01087788799; Email: wlhwq@yahoo.com
• Study Contact Backup: Name: Nan Bi, MD,PhD; Phone Number: 01087788799; Email: binan_emai@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

stage III patients with EGFR mutation.

Description

Inclusion Criteria:

• histologically confirmed NSCLC with adenocarcinoma
• stage III (AJCC 7th edition)
• inoperable or refuse surgery
• EGFR-TKI mutation, specimen from tissue or blood

Exclusion Criteria:

• the pathology was not adenocarcinoma
• stage I,II and IV
• anaplastic lymphoma kinase (ALK) rearrangement
• no follow-up data achievable

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Radiation(Chemo-radiation); Patients in this group had been treated with definitive radiation/Chemo-radiation followed by no treatment until progression.	Radiation: radiation or chemo-radiation; standard treatment for stage III lung cancer
radiation+EGFR-TKI; Patients in this group had been treated with one of the following three ways: 1) definitive radiation and concurrent EGFR-TKI followed by EGFR-TKI till progression; 2) EGFR-TKI followed by radiation and continue TKI util progression; 3) radiation and TKI thereafter until progression.	Radiation: radiation or chemo-radiation; standard treatment for stage III lung cancer; Drug: EGFR-TKI Inhibitor; the standard treatment for stage IV lung cancer with EGFR mutation; Other Names: EGFR-TKI alone
EGFR-TKI; Patients in this group had been treated with EGFR-TKI without any other treatment until progression.	Drug: EGFR-TKI Inhibitor; the standard treatment for stage IV lung cancer with EGFR mutation; Other Names: EGFR-TKI alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
median progression-free survival (mPFS)	The time of half patients who are alive and progression-free after the disease diagnose, estimated by the Kaplan-Maier method and using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.	Tumor scans had been performed at baseline, and every 3 months after the first treatment of EGFR-TKI or the last dose of radiation (whichever occurs first) in 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
median overall survival(mOS)	The time of half patients who are alive after the disease diagnose, estimated by the Kaplan-Maier method and using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.	Tumor scans had been performed at baseline, and every 3 months after the first treatment of EGFR-TKI or the last dose of radiation (whichever occurs first) in 5 years
failure pattern	Rate of disease failure in local, regional and distant sites.	Tumor scans had been performed at baseline, and every 3 months after the first treatment of EGFR-TKI or the last dose of radiation(whichever occurs first) in 5 years

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Luhua Wang, MD, Cancer center of Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2020
• Primary Completion (ANTICIPATED): May 1, 2020
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (ACTUAL): March 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CAMS19/216-2000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No