Clinical trial NCT04304638: Real-world Treatment Patterns and Clinical Outcomes in EGFR-mutant Unresectable Locally Advanced NSCLC
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cell Lung Cancer
Stage III Non-small-cell Lung Cancer
EGFR Mutation-Related Tumors
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2020-03-11
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: stage III patients with EGFR mutation.

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.

Eligibility criteria: 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

Primary outcomes:
measure: median progression-free survival (mPFS)
timeFrame: 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 outcomes:
measure: median overall survival(mOS)
timeFrame: 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
measure: failure pattern
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: Cancer center of Chinese Academy of Medical Sciences
name: Luhua Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: