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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01209650




Registration number
NCT01209650
Ethics application status
Date submitted
24/09/2010
Date registered
27/09/2010
Date last updated
10/11/2016

Titles & IDs
Public title
LUX Lung Special Access Scheme Australia Named Patient Use (NPU)
Scientific title
Expanded Access Program BIBW 2992 for Non Small Cell Lung Cancer ( NSCLC) Last Line Treatment
Secondary ID [1] 0 0
1200.47
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Treatment: Drugs - BIBW 2992

Treatment: Drugs: BIBW 2992
tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Inclusion criteria:

- Patients with pathologic confirmation of adenocarcinoma of the lung Stage IIIB with
pleural effusion or Stage IV
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Brain metastases which are symptomatic; patients with treated, asymptomatic brain
metastases are eligible with stable brain disease for at least four 4 weeks without
the requirement for steroids or anti epileptic therapy

- Significant or recent acute gastrointestinal disorders with diarrhea as a major
symptom as judged by the investigator.

- Patients who have any other life-threatening illness or organ system dysfunction,
which in the opinion of the investigator, would either compromise patient safety or
interfere with the evaluation of the safety of the test drug

- History of cardiac disease that is clinically significant, as judged by the
investigator or uncontrolled cardiac disease (including congestive heart failure,
angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA)
functional classification of 3)

- Cardiac left ventricular function with resting ejection fraction of less than 50%

- Bilirubin 1.5 mg / dl (26 mol / L, SI unit equivalent)

- Aspartate amino transferase (AST) or alanine amino transferase (ALT) three times the
upper limit of normal (if related to liver metastases five times the upper limit of
normal)

- Serum creatinine 1.5 times of the upper normal limit or calculated/measured creatine
clearance 45ml/min

- Women of child-bearing potential or men who are able to father a child unwilling to
use a medically acceptable method of contraception during the trial

- Pregnancy or breast feeding

- Patients unable to comply with the protocol

- Patients with known HIV, active hepatitis B or active hepatitis C

- Pre-existing Interstitial Lung Disease (ILD)

- Requirement for treatment with any of the prohibited concomitant medications listed in
Section 4.2.2.1.

- Patients already pre-treated with BIBW 2992

Study design
Purpose of the study
Allocation to intervention
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
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Approved for marketing
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
1200.47.1 Boehringer Ingelheim Investigational Site - North Ryde
Recruitment postcode(s) [1] 0 0
- North Ryde

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The program will provide early access to the investigational drug BIBW 2992 to treat patients
with advanced NSCLC who have failed at least 12 weeks on erlotinib or gefitinib.

The Compassionate Use Programme will also provide additional safety and efficacy information
on BIBW 2992 use.

Named Patient Use (NPU)
Trial website
https://clinicaltrials.gov/ct2/show/NCT01209650
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01209650