Assessing an Oral Janus Kinase Inhibitor, AZD4205, in Combination With Osimertinib in Patients Who Have Advanced Non-small Cell Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-16

Study Completion Date

2020-01-10

Brief Summary

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This study will treat patients with advanced NSCLC who have progressed following prior therapy. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy and in combination with Osimertinib.

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Detailed Description

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A phase I/II, open-label, multicentre study to investigate the safety, tolerability, pharmacokinetics and anti-tumour activity of AZD4205 as monotherapy or in combination with Osimertinib in patients with EGFR mutant advanced stage non-small cell lung cancer (NSCLC). This study includes dose escalation part and dose expansion part.

Conditions

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Nonsmall Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

dose escalation

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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daily dose of AZD4205

Group Type EXPERIMENTAL

AZD4205

Intervention Type DRUG

Daily dose of AZD4205, followed by daily dose of AZD4205 and Osimertinib 80 mg. Starting dose of AZD4205 at 75 mg, administered once daily. If tolerated, subsequent cohorts will test increasing doses of AZD4205, and in combination with Osimertinib 80 mg.

Interventions

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AZD4205

Daily dose of AZD4205, followed by daily dose of AZD4205 and Osimertinib 80 mg. Starting dose of AZD4205 at 75 mg, administered once daily. If tolerated, subsequent cohorts will test increasing doses of AZD4205, and in combination with Osimertinib 80 mg.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Obtained written informed consent
2. Patients must have histological or cytological confirmation of activating EGFR mutation positive NSCLC and have failed prior EGFR TKIs treatment.
3. Patients must exhibit Eastern Cooperative Oncology Group (ECOG) performance status 0-1
4. Adequate bone marrow reserve and organ system functions

Exclusion Criteria

1. Any unsolved toxicity \> CTCAE grade 1 from previous anti-cancer therapy (except alopecia)
2. Active viral or bacterial infections;
3. Active or latent tuberculosis;
4. History of interstitial lung disease (ILD)
5. History of heart failure or QT interval prolongation
6. Immunodeficiency diseases;
7. Active CNS metastases
8. Treatment with an EGFR TKI (e.g., erlotinib or gefitinib) within 8 days or approximately 5 x half-life, whichever is longer, of the first dose of study treatment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No