Author of

• 11745

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  P2.11 - Poster Session 2 - NSCLC Novel Therapies (ID 209)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/29/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 11758

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    P2.11-013 - A randomised phase II trial of Olaparib maintenance versus placebo monotherapy in patients with chemosensitive advanced non-small cell lung cancer (NSCLC) (ID 1375)

    09:30 - 09:30  |  Author(s): S. Bridges
    • Abstract

    Background
    In the UK approximately 35,000 people die from lung cancer annually, the majority from NSCLC. Chemotherapy is one of the main treatments for advanced NSCLC but those treated will still only live for an average of 9 or 10 months after diagnosis. Chemotherapy damages tumour cell DNA, and NSCLC tumours that respond to chemotherapy are less able to repair this damage. Olaparib blocks the Poly (ADP-ribose) polymerase (PARP) enzyme which is essential for DNA repair. It is hypothesized that if DNA repair is prevented then this will cause cancer cell death. The UK National Cancer Research Institute Lung Clinical Studies Group, as part of the National Cancer Research Network/AstraZeneca initiative, have developed this clinical trial to investigate whether or not giving Olaparib following chemotherapy will benefit patients with NSCLC who have responded to initial chemotherapy treatment by prolonging the time before the tumour re-grows. The study is funded by a research grant from Cancer Research UK (C16728/A14917) and an investigator sponsored grant and free drug from AstraZeneca. The trial is sponsored by Velindre NHS Trust, and coordinated by the Wales Cancer Trials Unit, Cardiff, UK.

    Methods
    A UK multicentre randomised phase II trial. Eligible patients include histological diagnosis of stage IIIB/IV squamous/non-squamous non small cell lung cancer, ECOG PS0-1, age>=18, chemonaive and having given informed consent. Figure 1 Patients are initially registered before induction chemotherapy after which if there is evidence of radiological response (partial or complete) they will be randomised to either Olaparib (300mg po bd q21) until disease progression, or placebo. Those with stable disease or progression will not be eligible for the main trial and will receive local standard treatment. The primary endpoint of the randomised trial is progression-free survival based on RECIST v1.1 with secondary endpoints of safety, tolerability, feasibility of use, response, overall survival and tumour volume reduction. The median PFS for patients with CR/PR after 3 – 4 cycles of induction chemotherapy treatment is expected to be 3 months. With 90% power and a one-sided α of 0.2, 114 participants are required to demonstrate statistical significance between the arms if the true hazard ratio for Olaparib compared to placebo is 0.65, based on the logrank test. We therefore aim to recruit 57 participants into each arm, over a 12 month accrual period, with minimum participant follow-up of at least 6 months. The primary analysis of data will be performed after 98 PFS events.

    Results
    Not applicable

    Conclusion
    Not applicable