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

 

ASPiRATION

Registered Title   An observational cohort study to assess the clinical impact of comprehensive genomic profiling in metastatic lung cancer patients (ASPiRATION).
Purpose  ASPiRATION is a clinical trial that is testing a new approach to providing personalised treatments for patients with newly diagnosed lung cancer through comprehensive genomic testing of patient's tumour tissue. The ASPiRATION study is being conducted as part of a larger research project called the Molecular Screening and Therapeutics (MoST) Program.
Lay Summary  N/A
WA Trial Sites   Ph. 08 6382 5513
Links  Australian New Zealand Clinical Trial Registry

Acknowledgments: Australian New Zealand Clinical Trial Registry

 

TPX-0131-01

Registered Title   A Phase 1/2 Study of TPX-0131, A Novel Oral ALK Tyrosine Kinase Inhibitor in Subjects With ALK+ Advanced or Metastatic NSCLC
Purpose  A phase 1/2, first-in-human, open-label study to evaluate the safety, tolerability, PK, and
efficacy of the novel ALK inhibitor TPX-0131 in pretreated subjects with ALK+ advanced or
metastatic non-small cell lung cancer (NSCLC). The study consists of two portions: 1) Phase 1
dose escalation, and 2) Phase 2 efficacy evaluation.
Lay Summary   N/A
WA Trial Sites    Ph. 08 6382 5513
 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

CA001-050

Registered Title   A Randomized, Open-label Phase 2 Clinical Trial of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer
Purpose  The purpose of this study is to demonstrate that treatment with BMS-986012 in combination
with carboplatin, etoposide, and nivolumab will have acceptable safety and tolerability and
will improve progression-free survival compared with carboplatin, etoposide, and nivolumab
alone in newly diagnosed participants with extensive-stage small cell lung cancer (ES-SCLC).
Lay Summary  N/A
WA Trial Sites   Ph. (08) 9428 8556
 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

CA224-104

Registered Title  A Phase 2 Randomized Double-blind Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC) 
Purpose  The purpose of this study is to assess the safety profile of nivolumab plus relatlimab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves progression free survival (PFS) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).
Lay Summary  N/A
WA Trial Sites   Ph. (08) 9428 8556
 Links   US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

EMBRACE

Registered Title   Phase II clinical trial of the PARP inhibitor, olaparib, in HR-deficient metastatic breast and relapsed ovarian cancer in patients without germline mutations in BRCA1 and BRCA2: The EMBRACE study
Purpose  This study is testing olaparib, in Homologous recombination (HR) deficient metastatic breast and relapsed ovarian cancer in patients who do not have hereditary mutations in BReast CAncer susceptibility gene 1 and gene 2 (BRCA1 and BRCA2).
Lay Summary  N/A
WA Trial Sites   Ph. 08 615 26530
 Links  Australian New Zealand Clinical Trial Registry

Acknowledgments: Australian New Zealand Clinical Trial Registry

 

SKYSCRAPER-03

Registered Title  A Phase III, Open-Label, Randomized Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Patients With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent Platinum-Based Chemoradiation
Purpose  The purpose of this study is to evaluate the efficacy and safety of atezolizumab in
combination with tiragolumab compared with durvalumab in participants with locally advanced,
unresectable Stage III non-small cell lung cancer (NSCLC) who have received at least two
cycles of concurrent platinum-based chemoradiotherapy (CRT) and have not had radiographic
disease progression.
Lay Summary  N/A
WA Trial Sites  Ph. 08 615 26530
Links US National Library of Medicine 
Acknowledgements: US National Library of Medicine

 

MARIPOSA

Registered Title  A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
Purpose  The purpose of this study is to assess the efficacy of the amivantamab and lazertinib
combination, compared with osimertinib, in participants with epidermal growth factor receptor
(EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive,
locally advanced or metastatic non-small cell lung cancer (NSCLC).
Lay Summary  N/A
WA Trial Sites  Ph. (08) 9428 8556
Links  US National Library of Medicine
Acknowledgements: US National Library of Medicine

 

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
Acknowledgements: 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

 

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   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   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   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    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   Ph. 08 615 26530
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     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

 Ph.  (08) 6465 9204

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

Mesothelioma Trials

 

NIPU

Registered Title  Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma (the NIPU-study)
Purpose The objective of the study is to induce a meaningful progression-free survival benefit in
patients with Malign Pleural Mesothelioma (MPM) after progression on first line standard
platinum doublet chemotherapy, by treating with nivolumab and ipilimumab with or without UV1 vaccine.  
Lay Summary  N/A  
WA Trial Sites  Oncology Ph. (08) 6383 3000
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

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   Oncology  Ph. (08) 6383 3000
 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine