A trial which will look into the effects of giving a drug to patients with non small cell lung cancer with the aim of improving survival outcomes.

Phase 1

• Conditions: on small cell lung cancer; MedDRA version: 19.0 Level: LLT Classification code 10025064 Term: Lung carcinoma System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-003608-19-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-01
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 37

Inclusion Criteria

Patient Inclusion Criteria

1. Any stage not suitable for radical treatment
2.Either:
Confirmed activating EGFR mutation (exons 18-21; eg L858R, exon 19 deletions, exon 20 insertions, T790M, this list is not exhaustive) and WHO PS 0-3

Or
•No tissue suitable for EGFR genotyping, failed genotype, or EGFR genotyping unavailable, and
•NSCLC Adenocarcinoma sub-type (including any WHO variant – see Appendix 4), and
•Eligible smoking history:
- Never smoker (<100 cigarettes in lifetime), or
- Former smoker (stopped >1year ago and =10 pack-years)
•and WHO PS 0-2
3. Predicted life expectancy = 8 weeks
4. Unsuitable for or patient declining chemotherapy due to significant co-morbidity
5. Measurable disease according to RECIST version 1.1
6. Age 18 or over (no upper age limit)
7. Adequate haematopoietic, hepatic and renal function defined as follows:
• Absolute neutrophil count (ANC) =1.5 x 109/L and platelet count =100 x 109/L
• Bilirubin =1.5 x ULN, ALT/AST(SGPT/SGOT) =3 x ULN (or = 5 x ULN in cases of liver metastases)
8.Serum creatinine clearance =45 ml/min using any local method
9. Palliative radiotherapy allowed unless to a solitary target lesion
10. Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Exclusion Criteria

1. Previous treatment with BIBW 2992, or any EGFR-directed inhibitor
2. Any concurrent anticancer systemic therapy
3. Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and registration
4. Suitable for radical radiotherapy
5. Palliative radiotherapy within 2 weeks prior to registration
6. Palliative radiotherapy to a solitary target lesion
7. Surgery (other than biopsy) within 4 weeks prior to registration
8. Inability to take oral medication, requirement for intravenous feeding, active peptic ulcer, prior surgical procedures affecting absorption or, any medical co-morbidity affecting gastrointestinal absorption
9. Patients with current or pre-existing interstitial lung disease
10. Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient’s participation in the trial
11. Significant or recent acute gastrointestinal abnormalities with diarrhoea as a major symptom e.g., Crohn’s disease, mal-absorption, or CTCAE v4.0 Grade =3 diarrhoea of any etiology at baseline
12. Active brain metastases (defined as stable for <4 weeks and/or symptomatic and/or requiring treatment with anticonvulsants and/or leptomeningeal disease. Steroids will be allowed if administered as a stable (same) dose for at least one month before trial entry
13. Any other current malignancy or malignancy diagnosed within the past five years (other than non-melanomatous skin cancer and in situ cervical cancer)
14. History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3 or more, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to registration
15. Symptomatic left ventricular failure with NYHA classification of 3 or more
16. Active viral hepatitis and/or known HIV positive
17. Known or suspected active drug or alcohol abuse
18. Use of any investigational drug within 8 weeks of registration
19. Known allergy to BIBW 2992 or other ingredients
20. Patients who have not been on the same dose of steroids for at least 4 weeks.
21. Inability to understand or to comply with the requirements of the trial, trial protocol or to provide informed consent
22. Women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial
23. Women who are pregnant or breast feeding
24. Requirement for treatment with any of the prohibited concomitant medications listed in protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified