Osimertinib for NSCLC With Uncommon EGFR Mutations

NCT05421936 | Suspended

• 1 other identifier: UNICORN_226_13
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, retrospective study of ucEGFRmut (exon 20 insertions excluded) metastatic NSCLC osimertinib-treated as first EGFR inhibitor. RECIST and RANO-BM brain objective response rate (ORR) were evaluated by investigators. mPFS, mOS and mDOR were calculated from osimertinib initiation. Mutations found at resistance were collected.

Conditions

Carcinoma, Non-Small-Cell Lung; Genes, erbB-1

Outcome Measures

Primary Outcomes (2)

• Progression free survival

  investigator-defined PFS

  From date of osimertinib initiation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

• Overall survival

  OS

  From date of osimertinib initiation until date of death from any cause, assessed up to 100 months

Secondary Outcomes (6)

• Overall response rate

  From date of osimertinib initiation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

• Brain response

  From date of osimertinib initiation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

• Adverse events on osimertinib

  From date of osimertinib initiation until 30 days after the date of last osimertinib treatment or date of death from any cause, whichever came first, assessed up to 100 months

• Time on treatment (TOT, on osimertinib)

  From date of osimertinib initiation until the date of last osimertinib treatment or date of death from any cause, whichever came first, assessed up to 100 months

• Time to CNS progression

  From date of osimertinib initiation until the date of first documented CNS progression or censured at last follow up or at date of death from any cause, whichever came first, assessed up to 100 months

Interventions

Osimertinib DRUG

Treatment as the first EGFR-TKI

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced NSCLC with uncommon EGFR mutation

You may qualify if:

• Age ≥ 18 years
• NSCLC by histologic or cytologic diagnosis
• Stage IV or stage III not amendable to curative treatment (i.e., advanced disease)
• Uncommon mutation of EGFR (exon 20 insertion excluded)
• Treated with osimertinib for advanced disease as first TKI
• Osimertinib initiated not later than end of January 2021

You may not qualify if:

• Lack of any follow-up data
• Lack of consent for data collection or ethics committee approval for the waiver of informed consent (i.e. for deceased patients)

Sponsors & Collaborators

• Sheba Medical Center: lead
• AstraZeneca: collaborator

Study Sites (1)

Sheba Medical Centre

Ramat Gan, 5265601, Israel

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Jair Bar, MD-PhD

  Sheba Medical Center, Ramat Gan, Israel

  PRINCIPAL INVESTIGATOR

• Alfredo Addeo, MD

  Geneva University Hospital, Geneva, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Thoracic Oncology Unit, Institute of Oncology

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: June 16, 2022
• Study Start: September 27, 2020
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

IL (1)