Value through Innovation27 July 2016

Clinical Study Results

  • BI 2536 - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1216.5
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I open-label dose escalation study of intravenous BI 2536 together with pemetrexed in previously treated patients with non-small-cell lung cancer

    Study Document Trial synopsis 1216.5_CO english
  • BI 2536 - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1216.9
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product BI 2536
    Generic Name BI 2536
    Lab Code
    Clinical Phase II
    Study Title

    An open, randomised clinical Phase II trial to investigate the efficacy, safety and pharmacokinetics of a single dose of 200 mg of i.v. BI 2536 in comparison to 50 mg of i.v. BI 2536 administered on days 1, 2 and 3 in patients with advanced or metastatic non small cell lung cancer

    Study Document Trial synopsis 1216.9_CO english
  • Bivatuzumab - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1170.3
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product Bivatuzumab
    Generic Name Bivatuzumab
    Lab Code
    Clinical Phase I
    Study Title

    A phase I biodistribution study with 186 Re-labelled humanised monoclonal antibody BIWA 4, in patients with non-small cell lung cancer.

    Study Document Trial synopsis 1170.3_CO english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.22
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    LUX Lung 2: A Phase II single arm trial of BIBW 2992 in non-small cell lung cancer patients with EGFR activating mutations

    Study Document Trial synopsis 1200.22_PE_DS_CO english Trial synopsis 1200.22_DS_CO english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.23
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IIb/III
    Study Title

    Phase IIb/III randomised, double-blind trial of BIBW 2992 plus best supportive care (BSC) versus placebo plus BSC in non-small cell lung cancer patients failing erlotinib or gefitinib (LUX-Lung 1)

    Study Document Trial snopsis 1200.23_CO english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.32
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase III
    Study Title

    LUX-Lung 3; A randomised, open-label, phase III study of BIBW 2992 versus chemotherapy as first-line treatment for patients with stage IIIB or IV adenocarcinoma of the lung harbouring an EGFR-activating mutation

    Study Document Trial synopsis 1200.32 english Lay summary 1200.32 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.33
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I/II
    Study Title

    LUX-Lung 4: A Phase I/II open label trial of continuous once daily oral treatment with BIBW 2992 – Phase I trial in advanced non small cell lung cancer patients & Phase II trial in non small cell lung cancer patients failing erlotinib or gefitinib – Full Analysis for Phase I. LUX-Lung 4: A Phase I/II open label trial of continuous once daily oraltreatment with BIBW 2992 – Phase I trial in advanced non small cell lung cancerpatients & Phase II trial in non small cell lung cancer patients failing erlotinib orgefitinib – Full Analysis for Phase II

    Study Document Trial synopsis 1200.33_Ph_1_DS_CO english Trial synopsis 1200.33_Ph_2_CO english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.41
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    A Phase II single-arm trial of BIBW 2992 in demographically and genotypically selected non-small cell lung cancer patients

    Study Document Trial synopsis 1200.41_DR english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.72
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    A Phase II trial of BIBW 2992 as a third-line treatment for patients with stage IIIB/IV adenocarcinoma of the lung harbouring wild-type EGFR

    Study Document Trial synopsis 1200.72_DS_CO english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.40
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase II
    Study Title

    A phase II single-arm trial of BIBW 2992 in EGFR FISH positive non-small cell lung cancer patients

    Study Document Trial synopsis 1200.40_DR english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.34
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase III
    Study Title

    LUX-Lung 6: A randomised, open-label, phase III study of BIBW 2992 versus chemotherapy as first-line treatment for patients with stage IIIB or IV adenocarcinoma of the lung harbouring an EGFR-activating mutation

    Study Document Trial synopsis 1200.34_PE english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.71
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase Ib
    Study Title

    A Phase Ib open-label clinical trial of continuous once daily oral treatment using BIBW 2992 plus cetuximab (Erbitux®) in patients with non-small cell lung cancer with progression following prior erlotinib (Tarceva®) or gefitinib (Iressa®)

    Study Document Trial synopsis 1200.71_PE_DR english Trial synopsis 1200.71_DR english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.42
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase III
    Study 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 (LUX lung 5)

    Study Document Trial synopsis 1200.42_OS english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.70
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase Ib
    Study Title

    A Phase Ib open-label clinical trial of continuous once daily oral treatment using BIBW 2992 plus sirolimus in patients with non-small cell lung cancer harbouring an EGFR mutation and/or disease progression following prior erlotinib or gefitinib

    Study Document Trial synopsis 1200.70_DR english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.125
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase III
    Study Title

    LUX-Lung 8: A randomized, open-label phase III trial of afatinib versus erlotinib in patients with advanced squamous cell carcinoma of the lung as second-line therapy following first-line platinum-based chemotherapy

    Study Document Trial synopsis 1200.125_OS english Lay summary 1200.125_OS english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.167
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IIIb
    Study Title

    A Phase IIIb, non-randomized, open-label, two-cohort study in patients with EGFR mutations-positive advanced adenocarcinoma of the lung, assessing the utility of the Afatinib Diarrhea Assessment and Management guidelines (ADAM)

    Study Document Trial synopsis 1200.167_DR english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.121
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase Ib
    Study Title

    A Phase 1b study of intermittent administration of high doses of the irreversible EGFR inhibitor afatinib as a means of achieving plasma levels active against non-small cell lung cancer with known T790M mutations

    Study Document Trial synopsis 1200.121_DR english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.123
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IIb
    Study Title

    LUX-Lung 7: A randomised, open-label Phase IIb Trial of afatinib versus gefitinib as first-line treatment of patients with EGFR mutation positive advanced adenocarcinoma of the lung

    Study Document Trial synopsis 1200.123_primary_analysis english Lay summary 1200.123_primary_analysis english Trial synopsis 1200.123_overall_survival english Lay summary 1200.123_overall_survival english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.29
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I study of continuous, concomitant oral treatment with BIBF 1120 and docetaxel - a Phase I, open-label, dose-escalation study in Japanese patients with stage IIIB/IV or recurrent non-small-cell lung cancer after failure of chemotherapy

    Study Document Trial synopsis 1199.29 english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.10
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase IIa
    Study Title

    Phase II trial of BIBF 1120 in patients with stage IIIB/IV non small cell lung cancer

    Study Document Trial synopsis 1199.10 english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.5
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase Ib
    Study Title

    A Phase I open label dose escalation study of continuous oral treatment with BIBF 1120 together with paclitaxel and carboplatin in patients with advanced stage non-small-cell lung cancer

    Study Document Trial synopsis 1199.5_CO english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.18
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I open label study of continuous oral treatment with BIBF 1120 ES together with pemetrexed in previously treated patients with non-small cell lung cancer

    Study Document Trial synopsis 1199.18_CO english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.13
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase III
    Study Title

    Multicentre, randomised, double-blind, Phase III trial to investigate the efficacyand safety of oral BIBF 1120 plus standard docetaxel therapy compared toplacebo plus standard docetaxel therapy in patients with stage IIIB/IV orrecurrent non small cell lung cancer after failure of first line chemotherapy(LUME Lung 1)

    Study Document Lay summary 1199.13 english Trial synopsis 1199.13 english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.14
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase III
    Study Title

    Multicentre, randomized, double-blind, Phase III trial to investigate the efficacy and safety of oral BIBF 1120 plus standard pemetrexed therapy compared to placebo plus standard pemetrexed therapy in patients with stage IIIB/IV or recurrent non-small cell lung cancer after failure of first-line chemotherapy (LUME Lung 2)

    Study Document Trial synopsis 1199.14_PE_DS_DR english Trial synopsis 1199.14_FU english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.28
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I/II
    Study Title

    A phase I/II study of continuous, concomitant oral treatment with BIBF 1120 and pemetrexed - a phase I, open-label, dose-escalation study - a phase II, 2 arm, randomised, double-blind, placebo-controlled study in Japanese patients with stage IIIB/IV or recurrent non-small-cell lung cancer after failure of chemotherapy

    Study Document Trial synopsis 1199.28 english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.128
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase III
    Study Title

    Multicentre, randomised, double-blind, Phase III trial to investigate the efficacy and safety of oral nintedanib plus docetaxel therapy compared to placebo plus docetaxel therapy in patients with stage IIIB/IV or recurrent, adenocarcinoma subtype non-small cell lung cancer after failure of first line chemotherapy

    Study Document Trial statement 1199.128_DR english Trial synopsis 1199.128_PR english
  • Sibrotuzumab - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1152.3
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product Sibrotuzumab
    Generic Name Sibrotuzumab
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I Single Dose Escalation Study of BIBH 1 in Patients with Non-Small Cell Lung Cancer Scheduled for Resection

    Study Document Trial synopsis 1152.3_CO english
  • Sibrotuzumab - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1152.6
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product Sibrotuzumab
    Generic Name Sibrotuzumab
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I Single Dose Escalation Study of 131 I-Sibrotuzumab in Patients with Advanced or Metastatic Non-Small Cell Lung Cancer

    Study Document Trial synopsis 1152.6_CO english
  • Volasertib - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1230.5
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product Volasertib
    Generic Name Volasertib
    Lab Code BI 6727
    Clinical Phase II
    Study Title

    A randomized open-label Phase II trial of BI 6727 monotherapy and BI 6727 in combination with standard dose pemetrexed compared to pemetrexed monotherapy in second line non-small cell lung cancer

    Study Document Trial synopsis 1230.5_DR english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.90
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase Ib
    Study Title

    An open label Phase I safety run-in trial of oral nintedanib plus docetaxel therapy in Japanese patients with locally advanced or metastatic adenocarcinoma subtype non-small cell lung cancer after failure of platinum-based first line chemotherapy

    Study Document Trial synopsis 1199.90 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.48
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IIIb
    Study Title

    An open label trial of afatinib in treatment-naive or chemotherapy pre-treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s)

    Study Document Trial synopsis 1200.48 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.208
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IV
    Study Title

    An open-label, single-arm Phase IV study of afatinib in patients with stage IV or recurrent Non-Small Cell Lung Cancer who have poor performance status and whose tumors have the common epidermal growth factor receptor (EGFR) mutations, Exon 19 deletions or Exon 21(L858R) substitution mutations

    Study Document Trial synopsis 1200.208 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.181
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IV
    Study Title

    Post marketing surveillance on long term drug use of GIOTRIF® Tablets in patients with epidermal growth factor receptor (EGFR) mutation-positive inoperable or recurrent non-small cell lung cancer (NSCLC).

    Study Document Trial synopsis 1200.181 english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.82
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I/II
    Study Title

    LUME-Lung 3: A Phase I/II study of continuous oral treatment with BIBF 1120 added to standard gemcitabine/cisplatin therapy in first-line NSCLC patients with squamous cell histology

    Study Document Trial synopsis 1199.82 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.217
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IV
    Study Title

    An open-label, single-arm phase IV study to assess the efficacy and safety of afatinib as second-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring an EGFR mutation (Del19 or L858R) who have failed first-line treatment with platinum-based chemotherapy

    Study Document Trial synopsis 1200.217 english
  • n/a - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.227
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product n/a
    Generic Name n/a
    Lab Code n/a
    Clinical Phase IV
    Study Title

    Evaluation of the impact of nurse-led telephone follow-up on treatment compliance of patients treated for a locally advanced or metastatic nonsmall- cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutation(s). The PARTAGE study.

    Study Document Trial synopsis 1200.227 english
  • GIOTRIF ® (afatinib) - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1200.270
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase IV
    Study Title

    RealGiDo: Real-world data on Gi(l)otrif® dose adjustment in first-line treatment, TKI-naïve, advanced non-small cell lung cancer patients with EGFR activating mutations

    Study Document Trial synopsis 1200.270 english
  • VARGATEF ® - Carcinoma, Non-Small-Cell Lung
    Clinical Study Number 1199.238
    Study Indication Carcinoma, Non-Small-Cell Lung
    Product VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I trial to investigate the effect of nintedanib on the pharmacokinetics of a combination of ethinylestradiol and levonorgestrel in patients with nonsmall cell lung cancer

    Study Document Trial synopsis 1199.238 english Lay summary 1199.238 english

Clinical Trial Registry and structured study results. Find here protocol information for all clinical study types.

European Trial Register of EU studies.