Clinical trial · Interventional
Assessing an Oral Janus Kinase Inhibitor, AZD4205, in Combination With Osimertinib in Patients Who Have Advanced Non-small Cell Lung Cancer
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nonsmall Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD4205 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- daily dose of AZD4205
- description
- daily dose of AZD4205
- interventionNames
- Drug: AZD4205
Primary outcomes (1)
- measure
- safety and tolerability of AZD4205
- timeFrame
- 21 days after the first dose
- description
- Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v4.0
Secondary outcomes (3)
- measure
- Objective Response Rate (ORR)
- timeFrame
- RECIST tumour assessments every 6 weeks from enrollment until study completion, an average of 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available