InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.Learn why

Optimise reading forHealth ProfessionalsPatients

Closed (no longer recruiting)Last updated: 30 January 2024

JACKPOT 001: This phase I/II trial is testing a new drug (AZD4205) alone and in combination with an oral drug (Osimertinib) in patients with advanced Non-Small Cell (NSC) Lung Cancer who progressed on prior treatmentA 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)

Clinical summary

Summary

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. This study includes dose escalation part and dose expansion part. In this study, participants will receive a daily dose of AZD4205, followed by daily dose of AZD4205 and Osimertinib 80 mg. The starting dose of AZD4205 will be 75 mg, administered once daily. If tolerated, subsequent cohorts will test increasing doses of AZD4205, and in combination with Osimertinib 80 mg.

Conditions

This trial is treating patients with Non-Small Cell (NSC) Lung Cancer.

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

I/II

Trial Acronym

JACKPOT 001

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Dizal (Jiangsu) Pharmaceutical Co., Ltd.

Scientific Title

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)

Eligibility

Inclusion

  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

  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

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

+ Show non-recruiting hospitals

Closed hospitals

Completed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

Speak with someone who has cancer clinical trial experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

CloseReport inaccuracy

Thank you for helping us to increase accuracy of the trial. Our team will validate the information and update the information as soon as possible.

Submitting ... Please wait

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.