Phase IIIB randomized trial of BIBW 2992 plus weekly paclitaxel versus Investigator's choise of chemotherapy following BIBW 2992 monotherapy in non-small cell lung cancer patients failing previous erlotinib or gefitinib treatment - LuxLung 5

Boehringer Ingelheim0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•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.

•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

发起方