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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04304638
• Other study ID #: CAMS19/216-2000
• Status: Not yet recruiting
• Start date: March 2020
• Est. completion date: June 2020

Study information

• Verified date: March 2020
• Source: Chinese Academy of Medical Sciences
• Contact: Luhua Wang, MD
• Phone: 01087788799
• Email: wlhwq[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: June 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• EGFR Mutation-Related Tumors
• Lung Neoplasms
• Non Small Cell Lung Cancer
• Stage III Non-small-cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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