Lung and Mesothelioma

The following list provides a brief description of lung cancer and mesothelioma trials that are open for recruitment in Western Australia. If you would like more information please follow the links provided, contact one of the trial sites or speak with your doctor.

Please note that this list is based on information provided to the Cancer Council by WA hospitals and may not include all clinical trials that are running in WA.

Where ‘N/A' appears - this means the lacking information has not been provided to date to the Cancer Council.

 Lung

Mesothelioma

 

Lung Cancer Trials

 

BR.31 Study

Registered Title

A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer.

Purpose

The purpose of this study is to find out whether it is better to receive a new drug, MEDI4736, or better to receive no further treatment after surgery (and possibly chemotherapy) for lung cancer.

Lay Summary

N/A

WA Trial Sites

Sir Charles Gairdner Hospital Logo

SCGH Medical Oncology
Ph. (08) 6383 3000

Fiona Stanley Hospital Logo

Cancer Centre Clinical Trials Unit
Caroline Stone
Clinical Trials Manager
Phone 08 615 26530 Fax 08 615 20954
caroline.stone@health.wa.gov.au

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

NIVORAD Study

Registered Title

NIVORAD - A randomised phase 2 trial of nivolumab and stereotactic ablative body radiotherapy in advanced non-small cell lung cancer, progressing after first or second line chemotherapy.

Purpose

The aim of this study is to determine the activity and safety of treating an asymptomatic, extrathoracic metastasis with a single fraction of SABR, during immunotherapy with nivolumab in advanced NSCLC progressing after 1 or 2 lines of chemotherapy.

Lay Summary

Who is it for?

Adults with advanced non-small-cell lung cancer (NSCLC) progressing after 1 or 2 lines of chemotherapy and with an asymptomatic, extrathoracic metastasis suitable for SABR. Tumour blocks must be available to test for PD-L1 expression.

Study details:

Participants will be randomly allocated in a ratio of 2:1 to either nivolumab 240mg every 2 weeks plus SABR (experimental) or nivolumab 240mg every 2 weeks alone (control). Nivolumab is continued until disease progression or prohibitive toxicity.

Participants will be assessed regularly for treatment response and side effects during the treatment and follow up phase. Clinical assessments will be performed before each cycle of nivolumab (2 weekly) and CT scans at baseline, week 6, 12, 18, 24 then 12 weekly until progression. Anticancer treatments and survival will be reviewed every 12 weeks after progression. This will enable us to determine the activity and safety of each treatment option in patients with an asymptomatic, extrathoracic metastasis.

WA Trial Sites

Sir Charles Gairdner Hospital Logo

SCGH Medical Oncology
Ph. (08) 6383 3000

Links

Australian New Zealand Clinical Trials Registry

 

Acknowledgements: Australian New Zealand Clinical Trials Registry

 

SAFRON II Trial (TROG Trial 13.01)

Registered Title

A Randomised Phase II Trial of Stereotactic Ablative Fractionated Radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the lung (SAFRON II).

Purpose

The purpose of this study is to assess toxicity, quality of life, clinical efficacy, cost effectiveness and immunogenicity of single fraction SABR and multi-fraction SABR in patients with limited (≤3) pulmonary metastases.

Lay Summary

Stereotactic Ablative Body Radiotherapy (SABR) is a new form of cancer radiotherapy treatment and there are two SABR techniques emerging in Australia; one which involves a single large treatment session and another which involves multiple smaller sessions.

The main purpose of this study is to examine the side effects of these two SABR techniques relative to each other, as well as to investigate the relative effectiveness and costs associated with each technique. This study will also examine the quality of life of participants who undergo the SABR treatment. By completing this study, we aim to determine which method of delivery is the best to be used in Australia and New Zealand in the future.

Participants will be randomised to receive either: ARM 1: Single Fraction SABR: 28Gy delivered 1 treatment session OR ARM 2: Multi Fraction SABR: 48 Gy delivered in 4 treatment sessions, delivered twice a week over 2 weeks, with each fraction on non-consecutive days.

This research study is expected to recruit 84 participants over a 3 year period.

WA Trial Sites

Sir Charles Gairdner Hospital Logo

Department of Radiation Oncology, Sir Charles Gairdner Hospital
Ph. (08) 6383 3202

Links

Trans Tasman Radiation Oncology Group (TROG)

 

 

Mesothelioma Trials

 

CheckMate 743 Study

Registered Title

A Phase III, Randomized, Open Label Trial of Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma.

Purpose

The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.

Lay Summary

N/A

WA Trial Sites

Sir Charles Gairdner Hospital Logo

SCGH Medical Oncology
Ph. (08) 6383 3000

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

DREAM Study

Registered Title

A phase 2 trial of durvalumab with first line chemotherapy in mesothelioma with a safety run in.

Purpose

This study will investigate the effectiveness of durvalumab in combination with standard chemotherapy for mesothelioma.

Lay Summary

Who is it for?

You may be eligible to join this study if you are aged 18 years or above, have had a diagnosis of malignant pleural mesothelioma that is not amenable to curative surgical resection.

Study details:

All participants in the study will receive standard first-line chemotherapy for mesothelioma and the new treatment, durvalumab, intravenously on day 1 of each 3 week cycle for a maximum number of 18 cycles. Participants will be followed-up for a minimum of 12 months to determine progression free survival and tumour response rate.

Durvalumab is an antibody (a type of human protein) that works by blocking a body substance called PD-L1. Blocking PD-L1 helps the body’s immune system to attack cancer cells. Research has shown that durvalumab can slow tumour growth and shrink tumours in some people with cancer. We plan to enrol 54 participants in this study from hospitals and clinics throughout Australia. Durvalumab is currently an experimental treatment. This means that it is not yet approved for the treatment of mesothelioma, or any other condition, in Australia, or in other countries.

WA Trial Sites

Sir Charles Gairdner Hospital Logo

SCGH Medical Oncology
Ph. (08) 6383 3000

Links

Australian New Zealand Clinical Trials Registry

Acknowledgements: Australian New Zealand Clinical Trials Registry

 

FGFR FRAME Mesothelioma Study

Registered Title

A two stage, open-label, phase II trial assessing the efficacy of a single oral agent AZD4547 in malignant mesothelioma.

Purpose

This primary purpose of this study is to evaluate the safety and efficacy of AZD4547 for the treatment of malignant mesothelioma which has progressed following first line chemotherapy. You may be eligible to participate in this study if you are aged 25 years or over, and have been diagnosed with mesothelioma which has progressed following first or second line chemotherapy with pemetrexed and cisplatin and/or carboplatin.

Lay Summary

Study details

All participants in this study will receive two oral doses of the study drug, AZD4547 per day for 6 months, with appointments with study staff every 3 weeks throughout this period to monitor side effects and adherence to the medication. Researchers will examine disease progression and survival at 6 months, as well as side effect data from the three-weekly appointments to determine the efficacy and safety of the drug.

Information from this study will then be used to inform researchers on whether continued study of this drug is both worthwhile and safe, in the hope that it may provide a safe and effective second line therapy for mesothelioma in patients whose disease has progressed following first line chemotherapy.

WA Trial Sites

Sir Charles Gairdner Hospital Logo

SCGH Medical Oncology
Ph. (08) 6383 3000

Links

Australian New Zealand Clinical Trials Registry

Acknowledgements: Australian New Zealand Clinical Trials Registry

 

 

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