Lung and Mesothelioma

he 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 Cancer Trials

 

CA209-234

Registered Title  Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice
Purpose This is an observational, multicenter study in patients treated with nivolumab for the
approved indications of melanoma and lung cancer in Australia, the EU, Switzerland, and the
United States (US). Targeted countries in the EU for study participation include Austria,
Belgium, France, Germany, Italy, Spain, and the United Kingdom (UK). Study objectives are to
assess the safety experience, survival, adverse event management, and outcomes of adverse
events associated with nivolumab in routine oncology care facilities.
Lay Summary  N/A
WA Trial Sites  St John of God Subiaco Ph. (08) 6465 9204
Links US National Library of Medicine 
Acknowledgements: US National Library of Medicine

 

KEYNOTE-495

Registered Title A Phase 2 Precision Oncology Study of Biomarker-Directed, Pembrolizumab-(MK-3475, SCH 900475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (KEYNOTE-495; KeyImPaCT)
Purpose  This study will investigate the utility of biomarker-based triage for study participants with
advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study
participants within groups defined by a biomarker-based classifier (gene expression profile
[GEP] and tumor mutational burden [TMB]) will be randomized to receive pembrolizumab in
combination with MK-1308, MK-4280, or lenvatinib. The primary hypotheses are as follows: In
participants receiving pembrolizumab in combination with either MK-1308, MK-4280, or
lenvatinib, the Objective Response Rate (ORR) will be 1) greater than 5% among participants
with low GEP and low TMB, 2) greater than 20% among participants with low GEP and high TMB,
3) greater than 20% among participants with high GEP and low TMB, and 4) greater than 45%
among participants with high GEP and high TMB.
Lay Summary  N/A
WA Trial Sites  Cancer Centre Clinical Trials Unit
Phone 08 615 26530
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

ATOMIC

Registered Title Ph 2/3 Study in Subjects With MPM w/Low ASS 1 Expression to Assess ADI-PEG 20 With Pemetrexed and Cisplatin
Purpose This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma with low argininosuccinate synthetase 1 expression. Malignant pleural mesothelioma have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the malignant pleural mesothelioma cells will starve and die.
Lay Summary  N/A
WA Trial Sites SCGH Medical Oncology Ph. (08) 6383 3000

 

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

CheckMate73L

Registered Title  A Phase 3, Randomized, Open Label Study to Compare Nivolumab Plus Concurrent Chemoradiotherapy (CCRT) Followed by Nivolumab Plus Ipilimumab or Nivolumab Plus CCRT Followed by Nivolumab vs CCRT Followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)
Purpose The primary purpose of the study is to compare the effectiveness of nivolumab + CCRT followed by nivolumab + ipilimumab (Arm A) vs CCRT followed by durvalumab (Arm C) in participants with untreated Locally Advanced Non-small Cell Lung Cancer
Lay Summary  N/A
WA Trials Sites  Murdoch Oncology Clinical Trials Unit
Ph. (08) 9428 8539
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

CS3006-101

Registered Title

A Phase I, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, PK and Antitumor Activities of the MEK Inhibitor CS3006 in Subjects With Locally Advanced or Metastatic Solid Tumors

Purpose

This is a multicenter, open label, dose escalation & expansion phase I study to evaluate the
clinical safety, tolerability, PK, and preliminary efficacy of CS3006.

Lay Summary

 N/A

WA Trials Sites

 0437 873 044

Links

 US National Library of Medicine

Acknowledgements: US National Library of Medicine


TACTI-002

Registered Title TACTI-002 (Two ACTive Immunotherapeutics): A Multicenter, Open Label, Phase II Study in Patients With Previously Untreated Unresectable or Metastatic Non-small Cell Lung Cancer (NSCLC), or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic Squamous Head and Neck Cancer (HNSCC) Receiving the Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) in Combination With Pembrolizumab (PD-1 Antagonist)
Purpose  Evaluate the safety and efficacy of the combination of eftilagimod alpha with pembrolizumab in non-small cell lung carcinoma and head and neck carcinoma patients.
Lay Summary  N/A
WA Trial Sites

 

St John of God - Subiaco (08) 6465 9204

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

LEAP-007

Registered Title A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) in Participants With Treatment-naïve, Metastatic Non-small Cell Lung Cancer (NSCLC) Whose Tumors Have a Tumor Proportion Score (TPS) Greater Than or Equal to 1% (LEAP-007)
Purpose  "The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.
Lay Summary  N/A
WA Trial Sites

 

Murdoch Oncology Clinical Trials Unit

Ph. (08) 9428 8539
oncologytrials.murdoch@sjog.org.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

 

DUBLIN-3

Registered Title
 Randomized Blinded Phase III Assessment of Second or Third-Line Chemotherapy With Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With Advanced Non-Small Cell Lung Cancer and With at Least One Measurable Lung Lesion
 Purpose

To compare the overall survival of NSCLC patients receiving 2nd- or 3rd-line systemic therapy with docetaxel + plinabulin (DP Arm) to patients treated with docetaxel + placebo (D5W) (D Arm) for advanced or metastatic disease.

 

 Lay Summary
N/A
 WA trial Sites

 

FSH - Cancer Centre Clinical Trials Unit (08) 615 26530

St John of God - Subiaco (08) 6465 9204

Mount Hospital Clinical Trials (08) 9481 8373

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

Checkmate-9LA

Registered Title A Study of Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs Chemotherapy Alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC) 
Purpose  The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease
Lay Summary  N/A
WA trial Sites

 

Murdoch Oncology Clinical Trials Unit (08) 9428 855

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine



Nivo Pass

Registered Title  Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice
Purpose  This is an observational, multicenter study in patients treated with nivolumab for the approved indications of melanoma and lung cancer in Australia, the EU, Switzerland, and the United States (US). Targeted countries in the EU for study participation include Austria, Belgium, France, Germany, Italy, Spain, and the United Kingdom (UK). Study objectives are to assess the safety experience, survival, adverse event management, and outcomes of adverse events associated with nivolumab in routine oncology care facilities.
Lay Summary  N/A
WA Trial Sites  St John of God - Subiaco (08) 6465 9204
Links  US National Library of Medicine
Acknowledgements: US National Library of Medicine

 

Mesothelioma Trials

 

 

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