Clinical Trials

21/011 SHERLOCK

SHERLOCK: Phase 2 trial of sotorasib in combination with carboplatin-pemetrexed and bevacizumab biosimilar as first line treatment for advanced non-squamous non-small cell lung cancerwith KRAS G12C mutation.

Recruitment target:

Status:

Open to Recruitment

Summary:

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.

Clinical trial design:

Single-arm, phase 2 study with a safety run-in.

Indication:

Newly-diagnosed or recurrent metastatic non-squamous NSCLC with KRAS G12C mutation (treatment naive for advanced disease).

Intervention:

All participants enrolled in this clinical trial will begin with Induction therapy of Sotorasib 960mg oral once daily, together with Carboplatin-Pemetrexed chemotherapy and Bevacizumab on day 1 every 3 weeks for 4 cycles.

More information:

For patients

For clinicians

Contact: sherlock.study@sydney.edu.au

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Open to Recruitment:

Open to Recruitment

ADOPT – Lung

The ADOPT-Lung study will examine disease free status (DFS) following 12 months of adjuvant durvalumab in addition to neoadjuvant chemotherapy and durvalumab in NSCLC patients who do not achieve a complete pathological response following surgery. ‘Operable’ patients will be given 3-4 cycles of neoadjuvant durvalumab and chemotherapy every 3 weeks, and provided the tumour is satisfactorily removed by surgery (R0 or R1), the patients will be randomised to 12 months of durvalumab given every 4 weeks, or observation. Participants will have CT scans every 12 weeks in the first year, and every 6 months in years 2 and 3. Blood will be collected at the scan visit to measure correlation of DFS with ctDNA clearance.

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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

20/007 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.

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