Safety & efficacy study of Debio 0932 in combination with SOC in NSCLC

• Research type

  Research Study

• Full title

  A Phase I-II evaluation of the safety and efficacy of the oral HSP90 inhibitor Debio 0932 in combination with standard of care in first- and second-line therapy of patients with Stage IIIb or IV Non-small Cell Lung Cancer - the HALO study (HSP90 inhibition And Lung cancer Outcomes)

• IRAS ID

  97786

• Contact name

  E R Plummer

• Sponsor organisation

  Debiopharm SA

• Eudract number

  2011-005533-39

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Non Small-Cell Lung Cancer (NSCLC) that cannot be cured by an operation, or advanced NSCLC, is an incurable disease that is treated with anti-cancer drugs. Debiopharm is a Swiss pharmaceutical company that is investigating a new treatment for advanced NSCLC. This treatment, Debio 0932, is given as tablets and will be tested in a clinical study in combination with standard treatment for advanced NSCLC. This study consists of three parts. Part A determines the maximum dose of Debio 0932 that can safely be given in combination with standard treatment for advanced NSCLC. For those patients who did not yet receive anti-cancer drugs for advanced NSCLC, and depending on the type of NSCLC that they have, this standard ??first-line? treatment consists of cisplatin and pemetrexed, or cisplatin and gemcitabine. For patients who already received treatment with anti-cancer drugs for advanced NSCLC but whose disease has progressed, the standard ??second-line? treatment is docetaxel. Subsequent groups of 3-6 patients will receive increasing doses of Debio 0932 in addition to their standard treatment, until side effects prohibit a further dose increase. In Part B, the dose of Debio 0932 identified in Part A is added to standard ??first-line? treatment as described under Part A. Half of the patients receive Debio 0932, and half of the patients receive placebo (a ??sugar pill?), to determine if Debio 0932 slows the progression of the disease. Patients in Part B whose NSCLC progresses despite treatment can enroll in Part C, where they receive Debio 0932 or placebo in combination with docetaxel. Also in Part C it will be determined if Debio 0932 slows the progression of the disease. Patients participate either in Part A or in Parts B . Importantly, all patients in this study receive standard treatment for their NSCLC.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  12/NE/0051

• Date of REC Opinion

  27 Feb 2012

• REC opinion

  Favourable Opinion