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

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

• Registration Number: NCT04304638
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

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.

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 Timeline

• Status Verified: 2020-03
• Study Start: 2020-03
• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-10
• Last Update Submitted: 2020-03-10
• Study First Posted: 2020-03-11
• Last Update Posted: 2020-03-11
• Primary Completion: 2020-05
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radiation(Chemo-radiation)	radiation or chemo-radiation	Patients in this group had been treated with definitive radiation/Chemo-radiation followed by no treatment until progression.
EGFR-TKI	EGFR-TKI Inhibitor	Patients in this group had been treated with EGFR-TKI without any other treatment until progression.
radiation+EGFR-TKI	radiation or chemo-radiation	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+EGFR-TKI	EGFR-TKI Inhibitor	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.

Primary Outcome Measures

Name	Time	Method
median progression-free survival (mPFS)	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	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.

Secondary Outcome Measures

Name	Time	Method
median overall survival(mOS)	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	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.
failure pattern	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	Rate of disease failure in local, regional and distant sites.