Concepts in Development

ALTG 15/004 BR.34:
A randomized trial of durvalumab (MEDI4736) and tremelimumab ± platinum-based chemotherapy in patients with high-risk advanced or metastatic (stage IIIB/IV) squamous or non-squamous NSCLC – B Hughes

  • The overall objective of this trial is to determine if durvalumab + tremelimumab, ± first-line platinum-based combined chemotherapy, improves overall survival in patients with incurable advanced or metastatic NSCLC
  • Planned global recruitment 300 (ANZ 100)
  • Open to active enrolment

ALTG14/001 BR.31:
Phase III Prospective Double Blind Placebo Controlled Randomised Study of Adjuvant MEDI4736 In Completely Resected NSCLC – S McLachlan

  • This purpose of this trial is to assess in comparison to placebo, the impact of adjuvant therapy with MEDI4736 given by IV infusion for one year on disease free survival (DFS) of patients with completely resected (stage IB >/= 4cm, stage II or IIIA) NSCLC that is Programmed death-ligand 1 (PD-L1) positive.
  • Planned global recruitment is 1,360 (ANZ 100)
  • Open to active enrolment

ALTG 16/005 OSCILLATE:
Alternating Osimertinib and Gefitinib in patients with EGFR T790M positive NSCLC – B Solomon

  • The purpose of this trial is to determine the efficacy and feasibility of alternating osimertinib and gefitinib in patients with EGFR-T790M mutation positive NSCLC.
  • Applicable to patients with EGFR mutation positive NSCLC that have acquired resistance to first or second generation EGFR TKIs and that are T790M positive.
  • Planned recruitment is 45 patients
  • Open to active enrolment

ALTG 16/007 ALKTERNATE:
Single arm phase 2 trial in ALK-rearranged NSCLC alTERNATing lortatinib with crizotinib after progression on first line crizotinib – N Pavlakis

  • This study aims to identify whether a fixed, ongoing alternating schedule of lorlatinib with crizotinib results in ongoing disease control and suppression of detectable innate or acquired ALK gene resistance mutations in blood; and to determine if ALK gene resistance mutations in circulating tumour DNA can be used to identify participants developing resistance before progression is clinically evident
  • Planned recruitment 40 patients from 15 sites
  • Concept submitted and under review for funding

 

ALTG 16/009 ILLUMINE:
A Phase 2 study of durvalumab plus tremelimumab in patients with relapsed EGFR mutant NSCLC – C Lee

  • This study aims to evaluate the efficacy and tolerability of combination durvalumab plus tremelimumab in patients with relapsed EGFR mutant NSCLC
  • Planned recruitment 50 from 15 sites
  • Concept submitted and under review for funding

ALTG 16/010 LungCare:
A multicentre randomised controlled trial comparing primary care vs hospital-based follow-up following surgical lobectomy for NSCLC – F Brims

  • Grant application submitted March 2017 to NHMRC, Cancer Australia and Cancer Council

ALTG 16/012 STIMULI:
A Phase 2 trial of consolidation with nivolumab and ipilimumab in limited-stage SCLC after chemo-radiotherapy – European Thoracic Oncology Platform (ETOP) study – P Mitchell

  • To evaluate if chemo-radiotherapy and prophylactic cranial irradiation followed by nivolumab and ipilimumab consolidation have better outcome (PFS and OS) compared to patients treated with chemo-radiotherapy and prophylactic cranial irradiation without nivolumab and ipilimumab consolidation
  • Planned global recruitment 260 (ANZ=50)
  • Study has recruited 84 patients to date with recruitment estimated to continue to 2019
  • Planned recruitment for 50 patients from 20-25 sites
  • Recruitment expected to open in early 2018

ALTG 17/001 Active surveillance in patients with MPM:
A prospective single arm phase II trial – A Nowak

  • Project grant submission planned for 2018
  • If successful, anticipated study start late 2018
Upcoming Events
  1. 4th ALTG Preceptorship in Lung Cancer, Melbourne, VIC

    August 17 - August 18