A Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib

NCT03239340 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: D5161C000032017-002359-27
• Study Type: interventional
• Target: 154
• Locations: 5 countries
• Sites: 26

Brief Summary

A multicentre, open-label, single-arm, molecular profiling study of patients with EGFR mutation-positive locally advanced or metastatic NSCLC treated with osimertinib.

Conditions

EGFR Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Keywords

EGFR, NSCLC, Lung Cancer, Biopsy, Molecular Profiling

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With a Given Tumour Genetic and Proteomic Marker at the Point of Disease Progression

  The frequency of genetic and proteomic markers at disease progression regardless of their prevalence was evaluated.

  Genetic and proteomic markers were assessed at baseline and progression (up to 5 years after baseline)

Secondary Outcomes (14)

• Progression Free Survival (PFS)

  From date of first dose until date of progression or death (by any cause in the absence of recurrence), up to 5 years

• Objective Response Rate (ORR)

  From date of first dose until progression, or last evaluable assessment in the absence of progression, up to 5 years

• Duration of Response (DoR)

  From date of first documentation of complete/partial response until the date of progression, or last evaluable RECIST assessment for participants that did not progress within 2 missed visits of last assessment, up to 5 years

• Disease Control Rate (DCR)

  8 weeks

• Time to Treatment Discontinuation or Death (TTD)

  From date of first dose to treatment discontinuation or death (by any cause in the absence of recurrence), up to 5 years

Study Arms (1)

Osimertinib

EXPERIMENTAL

An oral, potent, selective, irreversible inhibitor of both EGFR-tyrosine kinase inhibitor sensitizing and resistance mutations in non-small cell lung cancer

Drug: Osimertinib

Interventions

Osimertinib DRUG

Osimertinib is an oral, potent, selective, irreversible inhibitor of both EGFR-tyrosine kinase inhibitor sensitizing and resistance mutations in non-small cell lung cancer with a significant selectivity margin over wild type EGFR.

Also known as: TAGRISSO, AZD9291

Osimertinib

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior
• Patients aged 18 years or older
• Patients with histological confirmation of locally advanced or metastatic NSCLC
• Patients with M1 stage according to the Tumor, Node and Metastasis Classification of Malignant Tumours (TNM)
• Patients with an EGFR deletion or mutation known (from tumour biopsy or plasma) to be associated with EGFR TKI sensitivity
• Existence of measurable or evaluable disease (as per RECIST 1.1 criteria).
• Possibility of obtaining sufficient tissue sample, via a biopsy or surgical resection of the primary tumour or metastatic tumour tissue
• WHO performance status 0-1
• Life expectancy ≥12 weeks
• Capacity to swallow
• Patients able to complete study and within geographical proximity allowing for adequate follow up
• Resolution of all acute toxic effects of previous anticancer therapy
• Female patients must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of childbearing potential
• Male patients must be willing to use barrier contraception

You may not qualify if:

• Locally advanced lung cancer candidate for curative treatment through radical surgery and/or radio(chemo)therapy
• Patients diagnosed with another lung cancer subtype
• Patients with an EGFR exon 20 insertion
• Patients with just one measurable or evaluable tumour lesion that has been resected or irradiated prior to their enrolment in the study
• Second active neoplasia
• Treatment with an investigational drug within five half-lives of the compound
• Participation in another clinical study with an investigational product (IP) during the last 3 weeks before the first day of study treatment
• Patients who have received prior immunotherapies
• Patients who have received prior EGFR treatments for lung cancer
• Patients who have received prior treatment with an EGFR TKI including in the adjuvant setting
• Patients who have received previous treatment for metastatic or stage IV disease
• Prior treatment with cytotoxic chemotherapy for advanced NSCLC
• Patients with a history of cancer that has been completely treated, with no evidence of malignant disease currently cannot be enrolled in the study if their chemotherapy was completed less than 6 months prior and/or have received a bone marrow transplant less than 2 years before the first day of study treatment
• Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy
• Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses or active infection (eg, patients receiving treatment for infection) including hepatitis C and human immunodeficiency virus (HIV), or active uncontrolled Hepatitis B virus (HBV) infection.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (26)

Research Site

Athens, Georgia, 30607, United States

Location

Research Site

Atlanta, Georgia, 30307, United States

Location

Research Site

Boston, Massachusetts, 02215, United States

Location

Research Site

Brescia, 25100, Italy

Location

Research Site

Meldola, 47014, Italy

Location

Research Site

Monza, 20900, Italy

Location

Research Site

Parma, 43126, Italy

Location

Research Site

Roma, 00152, Italy

Location

Research Site

Terni, 05100, Italy

Location

Research Site

Johor Bahru, 81100, Malaysia

Location

Research Site

Kuantan, 25100, Malaysia

Location

Research Site

Kuching, 93586, Malaysia

Location

Research Site

Lembah Pantai, 59100, Malaysia

Location

Research Site

Pulau Pinang, 10450, Malaysia

Location

Research Site

Busan, 47392, South Korea

Location

Research Site

Cheongiu, 28644, South Korea

Location

Research Site

Seongnam, 13620, South Korea

Location

Research Site

Seoul, 03722, South Korea

Location

Research Site

Seoul, 05505, South Korea

Location

Research Site

Seoul, 06591, South Korea

Location

Research Site

Seoul, 135-710, South Korea

Location

Research Site

A Coruña, 15006, Spain

Location

Research Site

Barcelona, 08035, Spain

Location

Research Site

Las Palmas de Gran Canaria, 35016, Spain

Location

Research Site

Madrid, 28046, Spain

Location

Research Site

Seville, 41009, Spain

Location

Related Links

• Redacted CSR synopsis
• Redacted CSP
• Redacted SAP

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

osimertinib

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• Zosia Piotrowska, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 4, 2017
• Study Start: May 30, 2018
• Primary Completion: September 19, 2023
• Study Completion: September 19, 2023
• Last Updated: October 21, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

US (3); IT (6); MY (5); ES (5); KR (7)