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

NCT04304638 | Unknown FDA Drug

• 1 other identifier: CAMS19/216-2000
• Study Type: observational
• Target: 450
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (3)

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

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; Drug: EGFR-TKI Inhibitor

EGFR-TKI

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

Drug: EGFR-TKI Inhibitor

Interventions

radiation or chemo-radiation RADIATION

standard treatment for stage III lung cancer

Radiation(Chemo-radiation); radiation+EGFR-TKI

EGFR-TKI Inhibitor DRUG

the standard treatment for stage IV lung cancer with EGFR mutation

Also known as: EGFR-TKI alone

EGFR-TKI; radiation+EGFR-TKI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

stage III patients with EGFR mutation.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiation

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Luhua Wang, MD

  Cancer center of Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luhua Wang, MD

CONTACT

01087788799; wlhwq@yahoo.com

Nan Bi, MD,PhD

CONTACT

01087788799; binan_emai@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 11, 2020
• Study Start: March 1, 2020
• Primary Completion: May 1, 2020
• Study Completion: June 1, 2020
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share