Osimertinib for NSCLC With EGFR Exon 20 Insertion Mutation

NCT03414814 | Completed Phase 2 Results

• 1 other identifier: KCSG LU17-19
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, non-randomized multicentre phase 2 study in NSCLC patients with EGFR exon 20 insertion mutation, whose disease has progressed on standard chemotherapy.

Conditions

Locally Advanced or Metastatic NSCLC

Keywords

NSCLC; Osimertinib; EGFR exon 20 insertion mutation

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Investigator-assessed, confirmed objective response by RECIST version 1.1

  Until study completion, from date of initiation until the date of first documented progression, unacceptable toxicities or withdrawl, whichever came first. (upto about 29months)

Secondary Outcomes (3)

• Serious Adverse Events

  From date of initiation until the date of first documented progression, unacceptable toxicities or withdrawal, whichever came first. Until study completion. (upto about 29months)

• Progression-free Survival

  From date of initiation until the date of first documented progression, unacceptable toxicities or withdrawl, whichever came first. Until study completion. (upto about 29months)

• Overall Survival

  From the first date of IP administration to the date of death. (upto about 29months)

Study Arms (1)

Osimertinib

EXPERIMENTAL

Osimertinib at 80mg dose will be administered orally once daily.

Drug: Osimertinib 80 MG [Tagrisso]

Interventions

Osimertinib 80 MG [Tagrisso] DRUG

Osimertinib 80mg once daily until disease progression

Osimertinib

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures
• Male or female must be \> 19 years of age.
• Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy with local confirmation of the presence of the EGFR exon 20 insertion mutation
• Disease progression while on standard chemotherapy (platinum doublet chemotherapy or single-agent chemotherapy in selected patients)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Patients must have a life expectancy ≥ 12 weeks
• Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
• Male patients should be willing to use barrier contraception
• Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
• At least one measurable lesion
• Provision of archival FFPE tissue
• Provision of informed consent for translational genetic research

You may not qualify if:

• Involvement in the planning and/or conduct of the study (applies to both sponsor staff and/or staff at the study site)
• Previous treatment with osimertinib (3rd generation EGFR TKIs such as olumtinib, EGF816 etc)
• Treatment with an investigational drug within five half-lives of the compound
• Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inhibitors of CYP3A4 (at least 1 week prior) and potent inducers of CYP3A4 (at least 3 week prior) (Appendix A). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer/inhibitory effects on CYP3A4.
• Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (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, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
• Patients with symptomatic CNS metastases who are neurologically unstable; however, those with asymptomatic CNS metastases who do not require steroids for at least 4 weeks prior to start of osimertinib are eligible.
• Past medical history of ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
• Inadequate bone marrow reserve or organ function
• QTc prolongation (mean resting corrected QTc \> 470 msec)
• Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib
• History of hypersensitivity to osimertinib (or drugs with a similar chemical structure or class to osimertinib) or any excipients of these agents
• Males and females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry
• Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
• Previous allogeneic bone marrow transplant.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• AstraZeneca: collaborator
• Korean Cancer Study Group: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• Kim YJ, Kim S, Kim TM, Suh KJ, Kim M, Kim SH, Keam B, Kim DW, Lee JS, Heo DS. A phase II study of osimertinib in patients with NSCLC harboring EGFR exon 20 insertion: A multicenter trial of the Korean Cancer Study Group (LU17-19). Lung Cancer. 2024 Aug;194:107870. doi: 10.1016/j.lungcan.2024.107870. Epub 2024 Jul 3.

  PMID: 38986212 DERIVED

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

Results Point of Contact

• Title: Ji-Sook Kim
• Organization: Seoul National University Hospital

kbj3075814@snu.ac.kr

821025866440

Study Officials

• Tae Min Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: January 30, 2018
• Study Start: January 4, 2018
• Primary Completion: August 3, 2021
• Study Completion: August 3, 2021
• Last Updated: February 11, 2025
• Results First Posted: February 11, 2025

Record last verified: 2025-01

Locations

KR (1)