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NCT04595734
Liver Toxicity in Lung Cancer Patients Treated With Immune-checkpoint Inhibitors.
trial testing No intervention due to observational methods of study in Lung Cancer Stage IV in 500 participants. Status unknown.
10 January 2023
Quick facts
| Lead sponsor | Western Sydney Local Health District |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 7 January 2020 |
| Primary completion | 10 January 2023 |
| Estimated completion | 6 January 2025 |
| Sites | 3 locations across Australia |
Drugs / interventions tested
- No intervention due to observational methods of study
Conditions studied
- Lung Cancer Stage IV — all drugs for Lung Cancer Stage IV →
- Lung Cancer, Non-small Cell — all drugs for Lung Cancer, Non-small Cell →
- Hepatitis — all drugs for Hepatitis →
Sponsor
Western Sydney Local Health District — full company profile →
Who can join
Eligibility, any sex, with Lung Cancer Stage IV or Lung Cancer, Non-small Cell. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Immune-checkpoint inhibitors have recently become available as a new therapy for a variety of cancers. This drugs function by boosting the anti-cancer immune response, but unfortunately, may cause off-target, non-specific immune activation, resulting in liver and gut toxicity. In order to understand the development of liver immune-related adverse events we aim to collect full clinicopathological data from patients with advanced lung cancer treated with immune-checkpoint inhibitors at Blacktown, Westmead and Nepean Hospitals. Patients treated with standard chemotherapy will be used as a control group. This study aims to establish clinical risk factors that can predict the occurrence of liver immune-related adverse events in patients with advanced lung cancer treated with immune-checkpoint inhibitors. Such predictors may assist in the stratification of patients based on their risk for development liver toxicity as a result of immunotherapy, allowing early cessation/modification of treatment prior to the development of severe adverse reactions. In addition, this retrospective study will aim to determine the significance of pre-existing liver damage on the development of liver adverse events as well as establish a timeline defining the development of adverse events in the liver.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04595734
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Related trials
Other recruiting trials for Lung Cancer Stage IV
Currently open trials in the same condition.
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- NCT03728361 — Nivolumab and Temozolomide in Treating Patients With Recurrent or Refractory Small-Cell Lung Cancer or Advanced Neuroend · Phase 2 · active not recruiting
Other Western Sydney Local Health District trials
Trials by the same sponsor.
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- NCT06365411 — GEnomic Medicine in Kidney Transplantation Study · not yet recruiting
- NCT06828562 — GENomic Predictors in A Multi-Ethnic Population With Kidney Disease Study · enrolling by invitation
- NCT05509153 — A Randomised Controlled Trial, Of N-Acetyl Cysteine (NAC), for Premanifest Huntingtin Gene Expansion Carriers · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04595734 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Western Sydney Local Health District
- Last refreshed: 21 January 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04595734.
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