Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04335292

Osimertinib Then Chemotherapy in EGFR-mutated Lung Cancer with Osimertinib Third-line Rechallenge

Led by Mark Vincent · Updated on 2024-10-22

200

Participants Needed

10

Research Sites

333 weeks

Total Duration

On this page

Sponsors

M

Mark Vincent

Lead Sponsor

A

AstraZeneca

Collaborating Sponsor

AI-Summary

What this Trial Is About

This phase II single-armed study will examine the clinical utility of retreating patients with osimertinib, in the third-line, following first-line treatment with osimertinib and second-line treatment with platinum and pemetrexed chemotherapy. The current standard of care for first-line Epidermal Growth Factor Receptor (EGFR) mutated Advanced Non-Small Cell Lung Cancer (aNSCLC) is osimertinib, followed by cytotoxic chemotherapy. The repeat of osimertinib following previous treatment failure is investigational, although supported by scientific rationale. The dosing and scheduling of osimertinib follows its use in approved settings. The investigators examine its tolerability and efficacy in this setting to ensure osimertinib is a safe third-line option for patients with Epidermal Growth Factor Receptor mutated (EGFR+) Advanced Non-Small Cell Lung Cancer(aNSCLC).

CONDITIONS

Official Title

Osimertinib Then Chemotherapy in EGFR-mutated Lung Cancer with Osimertinib Third-line Rechallenge

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must provide informed consent before any study procedures
  • Male or female patients aged 18 years or older
  • Diagnosed with advanced non-small cell lung cancer (stage M1 or earlier if not suitable for radical treatment) confirmed by tissue or ctDNA analysis
  • Known activating EGFR mutation; atypical mutations allowed with approval; exon 20 insertions excluded
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-3 with potential for second-line chemotherapy
  • Expected life expectancy of at least 12 weeks
  • Females of child-bearing potential must use effective contraception, have a negative pregnancy test, and not be breastfeeding; non-child-bearing potential defined by menopause or surgical sterilization
  • Males must agree to use barrier contraception
  • Complete demographic and treatment data available for first-line progression and second-line chemotherapy
  • Received platinum and pemetrexed chemotherapy as second-line treatment
  • Must have at least one measurable lesion assessable by CT or MRI at baseline and follow-up
Not Eligible

You will not qualify if you...

  • Involvement in study planning or conduct
  • Second invasive malignancy within 3 years except localized non-melanoma skin cancer
  • Serious uncontrolled medical or psychiatric conditions interfering with study
  • Pregnancy or lactation
  • Use of investigational drugs within five half-lives or 3 months prior
  • Use of potent CYP3A4 inducers within 3 weeks prior
  • Unresolved toxicities above grade 1 except alopecia and certain neuropathies
  • Severe or uncontrolled systemic diseases including active infections (hepatitis B, C, HIV)
  • Spinal cord compression or symptomatic unstable brain metastases unless stable and asymptomatic
  • Gastrointestinal conditions preventing drug absorption
  • History or evidence of active interstitial lung disease
  • Inadequate bone marrow or organ function as defined by specific lab values
  • Hypersensitivity to osimertinib or related drugs
  • Likely non-compliance with study procedures
  • Recent adjuvant cytotoxic chemotherapy or anti-PD-1/PD-L1 therapy within specified timeframes
  • Cardiac abnormalities increasing risk of QT prolongation or arrhythmia
  • For third-line osimertinib rechallenge: must have received first-line osimertinib followed by second-line platinum and pemetrexed, with at least one dose given, and 90 days since last first-line osimertinib dose

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

BC Cancer Agency

Vancouver, British Columbia, Canada, V5Z 4E6

Actively Recruiting

2

Lions Gate Hospital

Vancouver, British Columbia, Canada, V7L 2L7

Actively Recruiting

3

William Osler Health System

Brampton, Ontario, Canada, L6R 3J7

Actively Recruiting

4

Hamilton Health Sciences Centre, Juravinski Cancer Centre

Hamilton, Ontario, Canada, L8V 5C2

Actively Recruiting

5

Grand River Regional Cancer Centre

Kitchener, Ontario, Canada, N2G 1G3

Actively Recruiting

6

London Regional Cancer Program of the Lawson Health Research Institute

London, Ontario, Canada, N6A 5W9

Actively Recruiting

7

Durham Regional Cancer Centre, Lakeridge Health

Oshawa, Ontario, Canada, L1G 2B9

Actively Recruiting

8

The Ottawa Hospital

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

9

Sunnybrook Research Institute

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

10

Princess Margaret Hospital

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

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Research Team

M

Mark Vincent, MD

CONTACT

D

Daniel Breadner, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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