Clinical Trials

20/004 ALK ASPiRATION SUBSTUDY

The ALK ASPiRATION substudy will confirm the activity of alectinib in the treatment of ALK+ metastatic NSCLC for patients where the ALK mutation was only detected by comprehensive genomic profiling. Alectinib works by blocking the action of an abnormal protein that signals cancer cells to multiply. Alectinib is available on the PBS for treatment of NSCLC with ALK mutation determined by fluorescence in situ hybridisation (FISH) testing.

Status:

Open to Recruitment

Summary:

A single arm, open label, phase II trial of alectinib in patients with advanced tumours harbouring ALK gene alterations detected by comprehensive genomic profiling (CGP) (MoST 14).

Clinical trial design:

Phase II single arm open label signal-seeking clinical trial

Indication:

Patients with advanced cancers harbouring ALK gene alterations identified using CGP. NSCLC patients with ALK gene alterations must be FISH-negative, i.e. not eligible for reimbursed ALK-targeted treatment

Intervention:

Patients will receive continuous alectinib 600 mg twice a day until disease progression, participant withdrawal or unacceptable toxicity.

More information:

For patients

For clinicians

ASPiRATION substudies include NSCLC-specific substudies and Omico MoST substudies that cater for NSCLC patients with tumours expressing the appropriate molecular biomarkers. The ASPiRATION substudies are all Phase II single arm open label signal-seeking clinical trials with the intent to demonstrate or confirm drug activity and safety in order to inform subsequent randomised Phase III clinical trials.

The ASPiRATION study and substudies are led by TOGA, in collaboration with Omico (Australian Genomic Cancer Medicine Centre) and the NHMRC Clinical Trials Centre (CTC), University of Sydney.

More Clinical Trials

Open to Recruitment:

Open to Recruitment

23/008 ASPECT

The aim is to establish the rates of radiation-induced lung disease outcomes, quality of life, and progression-free survival in lung cancer patients treated with Functional avoidance radiotherapy (Arm 1) and Standard radiotherapy (Arm 2)

Open to Recruitment

22/001 DYNAMALK

Eventual resistance to ALKi therapy remains inevitable. There is currently no predictive or prognostic biomarker accepted or available in routine clinical practice to guide the personalised management of advanced ALK+ cases from diagnosis and with each line of therapy, nor is there wide and timely accessibility of a ctDNA genomic panel to enable such molecular data in Australia. DYNAMALK aims to undertake molecular profiling via an Australian ctDNA study in treatment naïve and pre-treated ALK+ patients to describe and correlate ctDNA findings according to any prior therapies and temporal genomic profiles of patients recruited, to identify patterns of emerging resistance against clinical outcomes, and to report the influence of ctDNA genomic data obtained real time in informing clinical management over and above standard of care.

Open to Recruitment

20/001 HER2 ASPiRATION SUBSTUDY

The HER2 ASPiRATION substudy intends to demonstrate activity of trastuzumab emtansine in advanced HER2+ metastatic NSCLC. Trastuzumab emtansine is a drug known as an antibody drug conjugate (ADC) consisting of a monoclonal antibody trastuzumab, to target the tumour, that is covalently linked to the cytotoxic agent DM1. This drug has demonstrated efficacy in HER2+ breast cancer.

Open to Recruitment

20/007 OCEANiC

OCEANiC will investigate whether, following surgery for local or locally advanced EGFR+ NSCLC, patients with tumours containing certain types of genetic signatures can achieve the same disease-free survival with osimertinib treatment alone, as has previously been achieved with osimertinib and chemotherapy. Standard of care treatment is evolving to include osimertinib in addition to chemotherapy, but the OCEANiC trial may provide evidence for similar benefits for using the drug alone, with less toxicity, improved quality of life and reduced health care costs.

Open to Recruitment

21/011 SHERLOCK

SHERLOCK will examine whether sotorasib used in first line treatment of advanced KRAS G12C+ NSCLC, in combination with two chemotherapy drugs (called carboplatin and pemetrexed) and bevacizumab (which improves anti-cancer drug delivery) improves the response of the tumour to treatment. Sotorasib is available on the PBS as monotherapy in 2^nd or later lines of treatment. Patients with advanced KRAS G12C+ NSCLC usually undergo initial treatment with chemotherapy, immunotherapy or a combination of the two treatments.

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