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
CONTACT-01
| Registered Title | A Phase III, Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Atezolizumab Given in Combination With Cabozantinib Versus Docetaxel Monotherapy in Patients With Metastatic Non-Small Lung Cancer |
| Purpose | This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab given in combination with cabozantinib compared with docetaxel monotherapy in patients with metastatic NSCLC, with no sensitizing EGFR mutation or ALK translocation, who have progressed following treatment with platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody, administered concurrently or sequentially. |
| Lay Summary | N/A |
| WA Trial Sites |  (08) 9242 7640 |
| Links | US National Library of Medicine |
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 |
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 UnitPhone 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
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 |
|
| 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 |
|
| 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 |
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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