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

 

ILLUMINATE

Registered Title A Phase 2 Trial of Durvalumab (MEDI4736) and Tremelimumab With Chemotherapy in Metastatic EGFR Mutant Non-squamous Non-small Cell Lung Cancer (NSCLC) Following Progression on EGFR Tyrosine Kinase Inhibitors (TKIs)
Purpose The primary purpose of this trial is to evaluate the efficacy and tolerability of durvalumab
and tremelimumab with platinum-pemetrexed in patients with metastatic NSCLC (T790+ve or
T790M-ve) following progression on EGFR Tyrosine Kinase Inhibitors.
Lay Summary  It is hoped that the findings from this trial will provide information on whether treatment
with durvalumab and tremelimumab with platinum-pemetrexed is feasible, safe and effective for
the treatment of advanced non-small cell lung cancer.
WA Trial Sites  Medical Oncology Ph. (08) 6383 3000
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 Up to 120 patients will be recruited in the TACTI-002 (Two ACTive Immunotherapies) Phase II study which will take place across approximately 15 study centres in the U.S., Europe and Australia. It will evaluate the safety and efficacy of the combination of eftilagimod alpha with pembrolizumab in patients with advanced or metastatic non-small cell lung carcinoma or head and neck carcinoma.
WA Trial Sites   Ph. (08) 6465 9204
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

SPARTA

Registered Title Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
Purpose The primary Phase 1 purpose of this study is to assess overall safety and tolerability and
recommended Phase 2 dose (RP2D) of APL-101.   The Phase 2 portion will assess efficacy of the dose determined in Phase 1 in individuals    with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors.
Lay Summary  N/A
WA Trial SItes  Medical Oncology Ph. (08) 6383 3000
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

DZ2019E0001

Registered Title A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With EGFR or HER2 Mutation
Purpose This study will treat patients with advanced NSCLC with EGFR or HER2 mutation who have
progressed following prior therapy. This is the first time this drug is 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.
Lay Summary  N/A
WA Trial Sites  Linear Clinical Research Ph. 08 6382 5513
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

 

OUTRUN / TROG 17.02

Registered Title  Randomised phase II trial of Osimertinib with or without stereotactic radiosurgery for EGFR mutated NSCLC with brain metastases (TROG 17.02 OUTRUN) 
Purpose The aim of this study is to compare the effects of Osimertinib alone versus Osimertinib plus SRS on intra-cranial disease control in EGFR mutated NSCLC with brain metastases diagnosed or developed while on first line EGFR tyrosine kinase inhibitors.
Lay Summary  N/A
WA Trial Sites  Radiation Oncology Ph. 08 6383 3204
 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

CA224-020

Registered Title A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors
Purpose The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery.
Lay Summary  N/A
WA Trial Sites  Linear Clinical Research Ph. 08 6382 5513
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

BGB-900-103

Registered Title  A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors
Purpose This is an open-label, multicenter, non-randomized Phase 1b clinical trial for patients with histologically or cytologically confirmed locally advanced or metastatic tumors including non- squamous NSCLC, RCC, or OC. 
Lay Summary  N/a
WA Trial Sites  Linear Clinical Research Ph. 08 6382 5513
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

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

Linear Clinical Research Ph. 08 6382 5513 

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

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

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

  Cancer Centre Clinical Trials Unit (08) 615 26530

St John of God - Subiaco (08) 6465 9204

 Clinical Trials Ph. (08) 9481 8373

 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

 

ATOMIC

Registered Title   Randomized, Double-Blind, Phase 2/3 Study in Subjects with Malignant Pleural Mesothelioma with Low Argininosuccinate Synthetase 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  Radiation Oncology Ph. 08 6383 3204
 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

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