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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
LBH589 in combination with External Beam Radiotherapy or Chemoradiation for Locally Advanced Non Small Cell Lung Cancer
Scientific title
A dose finding study of oral LBH589 with radiation with or without chemotherapy for Stage III Non Small Cell Lung Cancer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer 3812 0
Condition category
Condition code
Cancer 3994 3994 0 0
Lung - Non small cell

Study type
Description of intervention(s) / exposure
Intervention group 1:
LBH589, an oral histone deacetylase inhibitor, will be combined with radiation for treatment of stage III non small cell lung cancer (NSCLC) in 3 increasing dose levels- 20 mg, 30 mg and 45 mg. The drug is administered orally. The radiation will be delivered to a total dose of 40 Gy in 2 Gy per fraction. 3 patients will start treatment with 20 mg LBH589 and radiation and observed for dose limiting toxicities. In case of no or minimal toxicities the next 3 patients will be treated at second dose level i.e. 30 mg. The next and final dose level will be 45 mg. A patient will be treated at only one particular dose level. The treatment will last for the duration of radiation, i.e. 4 weeks.
Intervention group 2:
Patients with stage III NSCLC will be treated with chemoradiation plus LBH589 in three increasing dose levels 20 mg, 30 mg and 45 mg. The total treatment duration will be 6 weeks. Radiation will be given at the dose of 60 Gy- 2 Gy per fraction. The chemotherapy will be intravenous cisplatin (50mg/m2 Days 1, 8 every 3 weeks) plus oral vinorelbine (50mg/m2 Days 1, 8 every 3 weeks) for 2 cycles. The first 3 patients will start treatment at 20 mg LBH589 with chemoradiation and observed for dose limiting toxicities. In case of no or minimal toxicities, the next three patients will be treated at 30 mg dose level. The final dose level will be 45 mg. The dose of chemotherapy and raditaion will remain constant throughout. A patient will be treated at only one dose level of LBH589 whether they experience any toxicity or not.
Intervention code [1] 3532 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 4898 0
dose limiting toxicity and maximum tolerated dose using classical Fibonacci's phase I trial design.
Timepoint [1] 4898 0
The patients will be assessed for toxicities twice a week during treatment. Final assessment will be at week 4 after last treatment.
Secondary outcome [1] 8273 0
response rate using computerised tomography (CT) scan
Timepoint [1] 8273 0
4 weeks after completion of radiation

Key inclusion criteria
Histological or cytological diagnosis of locally advanced (stage III) NSCLC
Adequate organ function
Performance score < 2
Adequate lung functions with forced expiratory volume (FEV1) > 1 L
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Concurrent treatment with other histone deacetylase inhibitors such as sodium valproate
Concurrent treatment with anti-arrythmics with a tendency to prolong QTc interval.
Patients on other investigational drugs within last 30 days
Pregnant or lactating females
Patients who have any severe and/or uncontrolled medical conditions
Malabsorption syndrome

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4044 0
Commercial sector/Industry
Name [1] 4044 0
Novartis Pharmaceuticals Australia Pty Limited
Address [1] 4044 0
54 Waterloo Road
North Ryde NSW 2113
Country [1] 4044 0
Primary sponsor type
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Secondary sponsor category [1] 3730 0
Name [1] 3730 0
Address [1] 3730 0
Country [1] 3730 0

Ethics approval
Ethics application status
Ethics committee name [1] 6071 0
Royal Adelaide Hospital
Ethics committee address [1] 6071 0
Ethics committee country [1] 6071 0
Date submitted for ethics approval [1] 6071 0
Approval date [1] 6071 0
Ethics approval number [1] 6071 0

Brief summary
The study will find the right amount of dose of a new oral drug called LBH589 in combination with radiation or chemoradiation for locally advanced lung cancer.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 29024 0
Address 29024 0
Country 29024 0
Phone 29024 0
Fax 29024 0
Email 29024 0
Contact person for public queries
Name 12181 0
Nimit Singhal
Address 12181 0
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 12181 0
Phone 12181 0
+61 8 882224398
Fax 12181 0
+61 8 882224358
Email 12181 0
Contact person for scientific queries
Name 3109 0
Nimit Singhal
Address 3109 0
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 3109 0
Phone 3109 0
+61 8 882224398
Fax 3109 0
+61 8 882224358
Email 3109 0

No information has been provided regarding IPD availability
Summary results
No Results