Active Trials


Back to Lung Cancer

 

BR.31
DREAM
OSCILLATE
PEARL
NIVORAD

BR.31

A phase III prospective double blind placebo controlled randomized study of adjuvant MEDI4736 in completely resected non-small cell lung cancer

Trial Summary:

This study looks at the effectiveness of adjuvant therapy with MEDI4736 in patients with completely resected non-small cell lung cancer. MEDI4736 is a human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour's immune-evading tactics. Participants will be randomised to receive treatment with either MEDI4736 or placebo. Two-thirds of the participants in this study will receive MEDI4736 and the other third will receive placebo. Participants will receive intravenous infusions of MEDI4736 or placebo every 4 weeks for 12 months (up to 13 infusions). Participants will then be followed for approximately 10 years to assess overall survival and disease free survival. 

Supported By: NCIC CTG, Astra Zeneca
Registration ID:ACTRN12615000323527
Participation:International
Australian Lead Group:ALTG
Status:Recruiting
Activation Date:17/07/2015
Chairs:Glenwood Goss (Intl.), Sue-Anne McLachlan (ANZ)
Contact:BR.31@ctc.usyd.edu.au

DREAM

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

Trial Summary:

Eligible partcipants are registered into the study. Durvalumab 1125mg AND chemotherapy (cisplatin 75mg/m2 and pemetrexed 500 mg/m2) are all given intravenously (IV) on day 1, repeated every 3 weeks for a maximum of 6 cycles. If there is no progression, continue durvalumab 1125mg IV on day 1 every 3 weeks for a maximum of an additional 12 cycles (18 cycles in total). Following study treatment phase patients will be follow up 4 weekly until disease progression. Anticancer treatment and survival every 12 weeks after progression.

Supported By: Astra Zeneca, ALTG, National Centre for Asbestos Related Diseases (NCARD) Perth
Eligibility:Adults commencing first-line doublet chemotherapy with cisplatin and pemetrexed for Malignant Pleural Mesothelioma.
Registration ID:(ANZCTR): 12616001170415
Participation:ANZ
Australian Lead Group:NHMRC CTC
Status:Recruiting
Activation Date:07/10/2016
Chairs:Anna Nowak (Sir Charles Gairdner Hospital)
Contact:dream@ctc.usyd.edu.au

OSCILLATE

Alternating Osimertinib and Gefitinib in patients with EGFR T790M positive NSCLC (Oscillate study).

Trial Summary:

The primary purpose of this trial is to evaluate the efficacy, safety and feasibility of osimertinib and gefitinib for the treatment of EGFR-T790M mutation positive advanced non-small cell lung cancer.

Supported By: AstraZeneca, ALTG
Eligibility: 1. Adults, aged 18 years and older, with histologically or cytologically confirmed metastatic or unresectable locally advanced NSCLC 2. Prior therapy with an EGFR-TKI. Patients may also have received additional lines of treatment 3. Documented evidence of EGFR-T790M mutation on tissue and/or plasma sample following disease progression on the most recent EGFR-TKI therapy (T790M mutation status will need to be re-confirmed in the event of an alternative systemic treatment following progression on the most-recent EGFR-TKI therapy). 4. Measurable disease according to RECIST version 1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Registration ID:ACTRN12617000720314
Participation:Australia
Australian Lead Group:NHMRC CTC
Status:Start-Up
Chairs:A/Prof Ben Soloman (Peter MacCallum Cancer Centre)
Contact:oscillate@ctc.usyd.edu.au

PEARL

PEARL – A randomised phase 3 trial of Palliative care Early in Advanced Lung Cancers.

Trial Summary:

Early referral to palliative care in advanced lung cancer has been shown to improve HRQL, OS and use of health care resources in a phase 3, randomised clinical trial of patients with newly diagnosed advanced NSCLC in the US. These benefits have not been corroborated in randomised trials in Canada and Australia in mixed cancer populations. The rationale for this trial is to determine if early referral to palliative care improves outcomes for patients with advanced thoracic malignancies in the Australian health care setting.
Participants will be allocated to one of the two study arms in a ratio of 1:1 (early referral to palliative care within 60 days of cancer diagnosis plus palliative care intervention plus standard oncological care OR discretionary referral to palliative care plus standard oncological care) by a central randomisation system that stratifies for:
1. Cancer type
2. Gender
3. Age
4. Planned / current use of chemotherapy
5. Australia-modified Karnofsky performance status
6. Study site.

Supported By: ALTG, Palliative Care Clinical Studies Collaborative (PaCCSC)
Eligibility:The target population is adults with advanced NSCLC, SCLC or MPM that has been newly diagnosed within the last 60 days.
Registration ID:(ANZCTR): 12617000166370
Participation:Australia
Australian Lead Group:NHMRC CTC
Status:Start-Up
Chairs:Linda Mileshkin (Peter MacCallum Cancer Centre)
Contact:pearl@ctc.usyd.edu.au

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.

Trial Summary:

Participants are 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.
Following study treatment phase patients will be follow up 12 weekly until disease progression. Anticancer treatment and survival every 12 weeks after progression.

Supported By: Bristol-Myers Squibb, ALTG, TROG
Eligibility:Adults with advanced non-small-cell lung cancer (NSCLC) progressing after 1 or 2 lines of chemotherapy and with an extra-pulmonary metastasis suitable for SABR. Tumour blocks must be available to test for PD-L1 expression.
Registration ID:(ANZCTR): 12616000352404
Participation:ANZ
Australian Lead Group:NHMRC CTC
Status:Recruiting
Activation Date:06/01/2017
Chairs:Paul Micthell (Austin Health)
Contact:nivorad@ctc.usyd.edu.au