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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Stage III Non-small-cell Lung Cancer; Non Small Cell Lung Cancer; EGFR Mutation-Related Tumors

Treatments: Drug: EGFR-TKI Inhibitor; Radiation: radiation or chemo-radiation

Study type: Observational

Funder types: Other

Identifiers

NCT04304638

CAMS19/216-2000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

450 participants in 3 patient groups

Radiation(Chemo-radiation)

Description:

Patients in this group had been treated with definitive radiation/Chemo-radiation followed by no treatment until progression.

Treatment:

Radiation: radiation or chemo-radiation

radiation+EGFR-TKI

Description:

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.

Treatment:

Drug: EGFR-TKI Inhibitor

Radiation: radiation or chemo-radiation

EGFR-TKI

Description:

Patients in this group had been treated with EGFR-TKI without any other treatment until progression.

Treatment:

Drug: EGFR-TKI Inhibitor