BIBW 2992 and Paclitaxel versus Chemotherapy in NSCLC

• Research type

  Research Study

• Full title

  Phase III randomized trial of BIBW 2992 plus weekly paclitaxel versus Investigator’s choice of chemotherapy following BIBW 2992 monotherapy in non-small cell lung cancer patients failing previous erlotinib or gefitinib treatment

• IRAS ID

  39852

• Contact name

  Riyaz Shah

• Sponsor organisation

  Boehringer Ingelheim Ltd

• Eudract number

  2009-014563-39

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a randomized, open label, active-controlled, multi-center trial to test whether patients with Non-Small Cell Lung Cancer (NSCLC) will have a greater benefit if treated with a combination of an irreversible tyrosine kinase inhibitor (TKI) called BIBW2992 with chemotherapy over chemotherapy alone. All patients will have been previously treated with approved TKIs and/or chemotherapy as a monotherapy in earlier lines of treatment. The study is split into two parts. Part A: The patient would receive BIBW2992 monotherapy until they have progression or unacceptable toxicity. If they have more than 12 weeks of disease stabilisation or response before progression then they are eligible to take part in the second phase of the study Part B: In this part they are given BIBW2992 in combination with paclitaxel or investigators choice of chemotherapy. The primary objective of the study is to determine the efficacy of BIBW 2992 plus weekly paclitaxel compared to investigator??s choice of chemotherapy alone after experiencing a benefit from BIBW 2992 monotherapy.

• REC name

  London - South East Research Ethics Committee

• REC reference

  10/H1102/16

• Date of REC Opinion

  26 Apr 2010

• REC opinion

  Further Information Favourable Opinion