non-small-cell lungcancer/ lungcancer
Conditions
Interventions
Part A:
BIBW 2992 monotherapy
Part B:
arm 1: BIBW 2992 plus Paclitaxel
arm 2: investigators choise of chemotherapy
Sponsors
Boehringer Ingelheim
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In study part A: 1: Patients with confirmed diagnosis of NSCLC stage IIIb or stage IV who have failed treatment with erlotinib or gefitinib. 2: patients should have received and failed at least one line of cytotoxic chemotherapy, including a platinum-based regimen in patients eligible for platinum-based therapy for advanced or metastatic disease, however the following patients are exempted: a) patients with known EGFR mutation shown by accepted methods after therapy with reversible TKI's are eligible without prior chemotherapy, OR b) patients with clinical benefit to erlotinib or gefitinib for 6 month or more and than experience progression of the disease are eligible without prior chemotherapy 3: Eastern Cooperative Oncology Group (ECOG, R01-0787) score 0,1,or 2. 4: Patients with at least one tumour lesion measured by MRI or CT scan in at least one dimension with the longest diameter to be recorded equal or larger than 20 mm using conventional techniques or equal or larger than 10 mm using spiral CT scan to RECIST 1.1 (R09-0262) 5: Male and female patients of 18 years or older 6: life expectancy of at least 12 weeks;In study part B: Clinical benefit (stable disease) for at least 12 weeks in part A of the trial, and than shown progression of the disease according to RECIST 1.1 criteria.
Exclusion criteria
Exclusion criteria: 1.previous treatment with BIBW 2. active brain metastasis 3. history or presence of clinically relevant cardiovasculair abnormalities 4. chemo-, hormone-, or immunotherapy within the past 4 weeks. For pre-treatment with reversible TKI's 2 weeks only. 5. significant or recent acute gastrointestinal disorder with diarrhea as a major symptom at baseline 6. other life-threatening illness or organ dysfunction, or other malignancies that either might compromise the patients safety or requiers therapy 7. radiotherapy within the past 2 weeks prior to treatment with the trial drug 8. history or presence of clinically relevant cardiovasculair abnormalities as defined in the exclusion criteria. 9. prior treatment with antracyclines with a cumulative dose of >= 400mg/m². 10. clinically significant abnormal lab functions as defined in the protocol 11. pregnant women, breastfeeding women or women of childbearing potential unwilling to use a medically acceptable method of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Overall survival time from the day of randomization until death for patients randomized to either BIBW 2992/ paclitaxel combination therapy or comparator chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: 1: progression free survival as determined by RECIST1.1(response evaluation criteria in solid tumours), separately for Part A and Part B 2: Clinical benefit rate at 3 month defined as the progression free survival rate at 3 month, separately for Part A and Part B 3: Objective response rate (CR {complete response} PR {partial response}) of BIBW 2992 monotherapy according to RECIST 1.1 4: Objective response rate (CR or PR) of BIBW 2992/ Paclitaxel combination therapy and comparator therapy in Part B after progression in Part A according to RECIST 1.1 5: Time to objective response, separately for Part A and Part B 6: HRQOL defined as time to deterioration fro the three symptoms cough, dyspnoe, and pain, measured using the European Organization for Research and Treatment of Cancer questionaires (QLO-LC13 and QLQ C30) | — |
Countries
Netherlands
Outcome results
None listed