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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-002072-10 | EudraCT Number | EudraCT |
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The trial will be performed to evaluate if BIBF 1120 in combination with standard pemetrexed therapy is more effective than placebo (inactive capsule) plus standard pemetrexed therapy in patients with stage IIIB, IV or recurrent NSCLC. Safety information about BIBF1120/pemetrexed will be obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nintedanib (BIBF1120) plus pemetrexed | Experimental | nintedanib (BIBF1120) along with standard therapy of pemetrexed |
|
| Placebo plus pemetrexed | Placebo Comparator | Pemetrexed standard therapy |
|
| nintedanib (BIBF1120) monotherapy | Experimental | nintedanib (BIBF1120) monotherapy only for patients who discontinue pemetrexed |
|
| pemetrexed monotherapy | Active Comparator | pemetrexed monotherapy only for patients who discontinue nintedanib (BIBF1120) or placebo |
|
| placebo monotherapy | Placebo Comparator | placebo monotherapy only for patients who discontinue pemetrexed |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nintedanib (BIBF1120) | Drug | starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) as Assessed by Central Independent Review | Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. | From randomisation until cut-off date 9 July 2012 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (Key Secondary Endpoint) | Overall Survival (OS) defined as the duration from randomisation to death (irrespective of the reason of death). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. | From randomisation until data cut-off (15 February 2013), Up to 30 months |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Downy | California | United States | |||
| Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28184431 | Derived | Lesaffre E, Edelman MJ, Hanna NH, Park K, Thatcher N, Willemsen S, Gaschler-Markefski B, Kaiser R, Manegold C. Statistical controversies in clinical research: futility analyses in oncology-lessons on potential pitfalls from a randomized controlled trial. Ann Oncol. 2017 Jul 1;28(7):1419-1426. doi: 10.1093/annonc/mdx042. |
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5 patients at one investigator site were excluded from the enrollment count because of site non-compliance.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nintedanib Plus Pemetrexed | Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Pemetrexed | Drug | 500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle. |
|
| pemetrexed | Drug | 500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle. |
|
| B12 | Drug | 1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed |
|
| dexamethasone (or corticosteroid equivalent) | Drug | 4 mg PO bid the day before, the day of and the day after each pemetrexed infusion |
|
| placebo | Drug | starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid. |
|
| dexamethasone (or corticosteroid equivalent) | Drug | 4 mg PO bid the day before, the day of and the day after each pemetrexed infusion |
|
| B12 | Drug | 1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed |
|
| Folic Acid | Drug | 400 ug once daily starting 1-2 weeks prior to the first dose of pemetrexed and continuing for at least 3 weeks after stopping pemetrexed. |
|
| B12 | Drug | 1000 ug IM injection starting a week before first pemetrexed infusion and every 9 weeks thereafter until discontinuation of pemetrexed |
|
| dexamethasone (or corticosteroid equivalent) | Drug | 4 mg PO bid the day before, the day of and the day after each pemetrexed infusion |
|
| Folic Acid | Drug | 400 ug once daily starting 1-2 weeks prior to the first dose of pemetrexed and continuing for at least 3 weeks after stopping pemetrexed. |
|
| placebo | Drug | starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid. |
|
| Folic Acid | Drug | 400 ug once daily starting 1-2 weeks prior to the first dose of pemetrexed and continuing for at least 3 weeks after stopping pemetrexed. |
|
| Nintedanib (BIBF1120) | Drug | starting dose of 200 mg bid taken daily except on the day of pemetrexed infusion . The dose can be reduced to 150 bid and then to 100 mg bid. |
|
| Pemetrexed | Drug | 500 mg/metre squared administered as an intravenous infusion over 10 minutes on Day 1 of each 21 day cycle. |
|
| Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review |
Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. |
| From randomisation until data cut-off (15 February 2013), Up to 30 months |
| Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator | Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by investigator according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. | From randomisation until data cut-off (15 February 2013), Up to 30 months |
| Objective Tumor Response | Confirmed objective response is defined as confirmed Complete Response (CR) and Partial Response (PR) and evaluated according to the modified RECIST criteria version 1.0. This endpoint was analysed based on the central independent reviewer as well as the investigator | From randomisation until data cut-off (15 February 2013), Up to 30 months |
| Duration of Confirmed Objective Tumour Response | The duration of objective response is the time from first documented (CR) or (PR) to the time of progression or death and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. This endpoint was analysed based on the central independent reviewer as well as the investigator. | From randomisation until data cut-off (15 February 2013), Up to 30 months |
| Time to Confirmed Objective Tumour Response | Time to confirmed objective response is defined as time from randomisation to the date of first documented (CR) or (PR) and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. This endpoint was analysed based on the central independent reviewer as well as the investigator. | From randomisation until data cut-off (15 February 2013), Up to 30 months |
| Disease Control | Disease control was defined as a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and evaluated according to the modified RECIST criteria version 1.0. This endpoint was analysed based on the central independent reviewer as well as the investigator. | From randomisation until data cut-off (15 February 2013), Up to 30 months |
| Duration of Disease Control | The duration of disease control was defined as the time from randomisation to the date of disease progression or death (which ever occurs first) for patients with disease control. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. This endpoint was analysed based on the central independent reviewer as well as the investigator. | From randomisation until data cut-off (15 February 2013), Up to 30 months |
| Change From Baseline in Tumour Size | Percentage change from baseline in tumour size is defined as decrease in the sum of the longest diameter of the target lesion. Presented means are in fact adjusted best means percentage changes generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no) This endpoint was analysed based on the central independent reviewer as well as the investigator. | From randomisation until data cut-off (15 February 2013), Up to 30 months |
| Clinical Improvement. | Clinical improvement was defined as the time from randomisation to deterioration in body weight and/or Eastern Cooperative Oncology group performance score (ECOG PS) whichever occurred first. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. | From randomisation until data cut-off (15 February 2013), Up to 30 months |
| Quality of Life (QoL) | QoL was measured by standardised questionnaires (EQ-5D, EORTC QLQ-C30, EORTC QLQ-LC13). The EORTC QLQ-C30 comprises of 30 questions, using both multi-item scales and single-item measures. EORTC LC-13 comprises of 13 questions incorporating 1 multi-item scale and a series of single items. The following were the main points of interest: Time to deterioration of cough (QLQ-LC13 question 1), Time to deterioration of dyspnoea (QLQ-LC13, composite of questions 3 to 5), Time to deterioration of pain (QLQ- C30, composite of questions 9 and 19). Time to deterioration of cough, dyspnoea and pain was defined as the time to a 10-point increase from the baseline score. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. | From randomisation until data cut-off (15 February 2013), Up to 30 months |
| Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide | Geometric mean of dose normalised predose plasma concentration (Cpre,ss,norm) of nintedanib and of its metabolites BIBF 1202 and BIBF 1202 glucuronide evaluated at steady state based on course 2 and 3. If only one value was available and valid, then this value was used for calculation of Cpre,ss,norm. | Before the administration of nintedanib or placebo and between a window of 30 mins to an hour after administration of trial drug during Course 2 and between 1 and 3 hours after administration of trial drug during Course 3 |
| Incidence and Intensity of Adverse Events | Incidence and intensity of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The worst CTCAE grade per patient is reported and MedDRA version 15.1 used. Serious signs and symptoms of progressive disease were reported as an adverse event in analysis of this endpoint. | From the first drug administration until 28 days after the last drug administration, up to 36 months |
| Fountain Valley |
| California |
| United States |
| Boehringer Ingelheim Investigational Site | Fullerton | California | United States |
| Boehringer Ingelheim Investigational Site | Long Beach | California | United States |
| Boehringer Ingelheim Investigational Site | Meriden | Connecticut | United States |
| Boehringer Ingelheim Investigational Site | Aventura | Florida | United States |
| Boehringer Ingelheim Investigational Site | Boynton Beach | Florida | United States |
| Boehringer Ingelheim Investigational Site | Jacksonville | Florida | United States |
| Boehringer Ingelheim Investigational Site | Miami | Florida | United States |
| Boehringer Ingelheim Investigational Site | New Port Richey | Florida | United States |
| Boehringer Ingelheim Investigational Site | Port Saint Lucie | Florida | United States |
| Boehringer Ingelheim Investigational Site | Stuart | Florida | United States |
| Boehringer Ingelheim Investigational Site | Galesburg | Illinois | United States |
| Boehringer Ingelheim Investigational Site | Skokie | Illinois | United States |
| Boehringer Ingelheim Investigational Site | Indianapolis | Indiana | United States |
| Boehringer Ingelheim Investigational Site | New Albany | Indiana | United States |
| Boehringer Ingelheim Investigational Site | Witchita | Kansas | United States |
| Boehringer Ingelheim Investigational Site | Ashland | Kentucky | United States |
| Boehringer Ingelheim Investigational Site | Louisville | Kentucky | United States |
| Boehringer Ingelheim Investigational Site | Burlington | Massachusetts | United States |
| Boehringer Ingelheim Investigational Site | Springfield | Massachusetts | United States |
| Boehringer Ingelheim Investigational Site | Saint Louis Park | Minnesota | United States |
| Boehringer Ingelheim Investigational Site | Grand Island | Nebraska | United States |
| Boehringer Ingelheim Investigational Site | Farmington | New Mexico | United States |
| Boehringer Ingelheim Investigational Site | Dunkirk | New York | United States |
| Boehringer Ingelheim Investigational Site | Goshen | New York | United States |
| Boehringer Ingelheim Investigational Site | Lake Success | New York | United States |
| Boehringer Ingelheim Investigational Site | Nyack | New York | United States |
| Boehringer Ingelheim Investigational Site | Asheville | North Carolina | United States |
| Boehringer Ingelheim Investigational Site | Canton | Ohio | United States |
| Boehringer Ingelheim Investigational Site | Sandusky | Ohio | United States |
| Boehringer Ingelheim Investigational Site | Ephrata | Pennsylvania | United States |
| Boehringer Ingelheim Investigational Site | Langhorne | Pennsylvania | United States |
| Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States |
| Boehringer Ingelheim Investigational Site | Germantown | Tennessee | United States |
| Boehringer Ingelheim Investigational Site | Amarillo | Texas | United States |
| Boehringer Ingelheim Investigational Site | Seattle | Washington | United States |
| Boehringer Ingelheim Investigational Site | Spokane | Washington | United States |
| Boehringer Ingelheim Investigational Site | Madison | Wisconsin | United States |
| Boehringer Ingelheim Investigational Site | Milwaukee | Wisconsin | United States |
| Boehringer Ingelheim Investigational Site | Bs. As. Codigo Buenos Aires | Argentina |
| Boehringer Ingelheim Investigational Site | Córdoba | Argentina |
| Boehringer Ingelheim Investigational Site | Pergamino | Argentina |
| Boehringer Ingelheim Investigational Site | Quilmes Buenos Aires | Argentina |
| Boehringer Ingelheim Investigational Site | Rosario, Santa Fe | Argentina |
| Boehringer Ingelheim Investigational Site | San Miguel de Tucumán | Argentina |
| Boehringer Ingelheim Investigational Site | Sydney | New South Wales | Australia |
| Boehringer Ingelheim Investigational Site | Brisbane | Queensland | Australia |
| Boehringer Ingelheim Investigational Site | Adelaide | South Australia | Australia |
| Boehringer Ingelheim Investigational Site | Toorak Gardens | South Australia | Australia |
| Boehringer Ingelheim Investigational Site | Melbourne | Victoria | Australia |
| Boehringer Ingelheim Investigational Site | Perth | Western Australia | Australia |
| Boehringer Ingelheim Investigational Site | Sydney | Australia |
| Boehringer Ingelheim Investigational Site | Banja Luka | Bosnia and Herzegovina |
| Boehringer Ingelheim Investigational Site | Sarajevo | Bosnia and Herzegovina |
| Boehringer Ingelheim Investigational Site | Belo Horizonte | Brazil |
| Boehringer Ingelheim Investigational Site | Belo Horizonte,Minas Gerais | Brazil |
| Boehringer Ingelheim Investigational Site | Cachoeira Do Itapemirim-ES | Brazil |
| Boehringer Ingelheim Investigational Site | Campinas SP | Brazil |
| Boehringer Ingelheim Investigational Site | Caxias do Sul | Brazil |
| Boehringer Ingelheim Investigational Site | Curitiba | Brazil |
| Boehringer Ingelheim Investigational Site | Florianópolis | Brazil |
| Boehringer Ingelheim Investigational Site | Goiania Goias | Brazil |
| Boehringer Ingelheim Investigational Site | Ijuí | Brazil |
| Boehringer Ingelheim Investigational Site | Itajaí | Brazil |
| Boehringer Ingelheim Investigational Site | Jau/SP | Brazil |
| Boehringer Ingelheim Investigational Site | Londrina, Parana | Brazil |
| Boehringer Ingelheim Investigational Site | Pelotas Rio Grande Do Sul | Brazil |
| Boehringer Ingelheim Investigational Site | Porto Alegre | Brazil |
| Boehringer Ingelheim Investigational Site | Rio de Janeiro | Brazil |
| Boehringer Ingelheim Investigational Site | Salvador Bahia | Brazil |
| Boehringer Ingelheim Investigational Site | Santo André | Brazil |
| Boehringer Ingelheim Investigational Site | Sao Paulo - SP | Brazil |
| Boehringer Ingelheim Investigational Site | São Paulo | Brazil |
| Boehringer Ingelheim Investigational Site | Sorocaba Sao Paulo | Brazil |
| Boehringer Ingelheim Investigational Site | Thunder Bay | Ontario | Canada |
| Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada |
| Boehringer Ingelheim Investigational Site | Québec | Quebec | Canada |
| Boehringer Ingelheim Investigational Site | Jardin Del Mar, Renaca | Chile |
| Boehringer Ingelheim Investigational Site | Las Condes | Chile |
| Boehringer Ingelheim Investigational Site | Santiago | Chile |
| Boehringer Ingelheim Investigational Site | Temuco | Chile |
| Boehringer Ingelheim Investigational Site | Monteria, Cordoba | Colombia |
| Boehringer Ingelheim Investigational Site | Cuenca | Ecuador |
| Boehringer Ingelheim Investigational Site | Quito | Ecuador |
| Boehringer Ingelheim Investigational Site | Augsburg | Germany |
| Boehringer Ingelheim Investigational Site | Berlin | Germany |
| Boehringer Ingelheim Investigational Site | Gauting | Germany |
| Boehringer Ingelheim Investigational Site | Halle | Germany |
| Boehringer Ingelheim Investigational Site | Hemer | Germany |
| Boehringer Ingelheim Investigational Site | München | Germany |
| Boehringer Ingelheim Investigational Site | Hong Kong | Hong Kong |
| Boehringer Ingelheim Investigational Site | Deszk | Hungary |
| Boehringer Ingelheim Investigational Site | Nyíregyháza | Hungary |
| Boehringer Ingelheim Investigational Site | Pécs | Hungary |
| Boehringer Ingelheim Investigational Site | Dublin | Ireland |
| Boehringer Ingelheim Investigational Site | Daugavpils | Latvia |
| Boehringer Ingelheim Investigational Site | Liepāja | Latvia |
| Boehringer Ingelheim Investigational Site | Riga | Latvia |
| Boehringer Ingelheim Investigational Site | George Town | Malaysia |
| Boehringer Ingelheim Investigational Site | Kota Kinabalu | Malaysia |
| Boehringer Ingelheim Investigational Site | Kuala Lumpur | Malaysia |
| Boehringer Ingelheim Investigational Site | Kuching | Malaysia |
| Boehringer Ingelheim Investigational Site | Chihuahua City | Mexico |
| Boehringer Ingelheim Investigational Site | Morelia | Mexico |
| Boehringer Ingelheim Investigational Site | Chisinau | Moldova |
| Boehringer Ingelheim Investigational Site | 's-Hertogenbosch | Netherlands |
| Boehringer Ingelheim Investigational Site | Auckland | New Zealand |
| Boehringer Ingelheim Investigational Site | Christchurch | New Zealand |
| Boehringer Ingelheim Investigational Site | Palmerston North | New Zealand |
| Boehringer Ingelheim Investigational Site | Wellington | New Zealand |
| Boehringer Ingelheim Investigational Site | Bitola | North Macedonia |
| Boehringer Ingelheim Investigational Site | Skopje | North Macedonia |
| Boehringer Ingelheim Investigational Site | Carrasquilla Panama | Panama |
| Boehringer Ingelheim Investigational Site | Panama City | Panama |
| Boehringer Ingelheim Investigational Site | Arequipa | Peru |
| Boehringer Ingelheim Investigational Site | Cercado Arequipa | Peru |
| Boehringer Ingelheim Investigational Site | Lima | Peru |
| Boehringer Ingelheim Investigational Site | Cebu | Philippines |
| Boehringer Ingelheim Investigational Site | Davao City | Philippines |
| Boehringer Ingelheim Investigational Site | Makati | Philippines |
| Boehringer Ingelheim Investigational Site | Quezon | Philippines |
| Boehringer Ingelheim Investigational Site | Olsztyn | Poland |
| Boehringer Ingelheim Investigational Site | Baia Mare | Romania |
| Boehringer Ingelheim Investigational Site | Bucharest | Romania |
| Boehringer Ingelheim Investigational Site | Cluj-Napoca | Romania |
| Boehringer Ingelheim Investigational Site | Iași | Romania |
| Boehringer Ingelheim Investigational Site | Onești | Romania |
| Boehringer Ingelheim Investigational Site | Timișoara | Romania |
| Boehringer Ingelheim Investigational Site | Belgrade | Serbia |
| Boehringer Ingelheim Investigational Site | Kamenitz | Serbia |
| Boehringer Ingelheim Investigational Site | Niš | Serbia |
| Boehringer Ingelheim Investigational Site | Daegu | South Korea |
| Boehringer Ingelheim Investigational Site | Daejoen | South Korea |
| Boehringer Ingelheim Investigational Site | Gangdong-gu, Seoul | South Korea |
| Boehringer Ingelheim Investigational Site | Gyeonggi-do | South Korea |
| Boehringer Ingelheim Investigational Site | Jeonbuk | South Korea |
| Boehringer Ingelheim Investigational Site | Seochogu, Seoul | South Korea |
| Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| Boehringer Ingelheim Investigational Site | Suwon | South Korea |
| Boehringer Ingelheim Investigational Site | Gävle | Sweden |
| Boehringer Ingelheim Investigational Site | Stockholm | Sweden |
| Boehringer Ingelheim Investigational Site | Umeå | Sweden |
| Boehringer Ingelheim Investigational Site | Uppsala | Sweden |
| Boehringer Ingelheim Investigational Site | Kaohsiung City | Taiwan |
| Boehringer Ingelheim Investigational Site | Taichung | Taiwan |
| Boehringer Ingelheim Investigational Site | Tainan | Taiwan |
| Boehringer Ingelheim Investigational Site | Taipei | Taiwan |
| Boehringer Ingelheim Investigational Site | Bangkok | Thailand |
| Boehringer Ingelheim Investigational Site | Chiang Mai | Thailand |
| Boehringer Ingelheim Investigational Site | Ankara | Turkey (Türkiye) |
| Boehringer Ingelheim Investigational Site | Antalya | Turkey (Türkiye) |
| Boehringer Ingelheim Investigational Site | Aydin | Turkey (Türkiye) |
| Boehringer Ingelheim Investigational Site | Balcali-Adana | Turkey (Türkiye) |
| Boehringer Ingelheim Investigational Site | Diyarbakır | Turkey (Türkiye) |
| Boehringer Ingelheim Investigational Site | Gaziantep | Turkey (Türkiye) |
| Boehringer Ingelheim Investigational Site | Kocaeli | Turkey (Türkiye) |
| Boehringer Ingelheim Investigational Site | Chernihiv | Ukraine |
| Boehringer Ingelheim Investigational Site | Dnipropetrovks | Ukraine |
| Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine |
| Boehringer Ingelheim Investigational Site | Uzhhorod | Ukraine |
| Boehringer Ingelheim Investigational Site | Vinnytsia | Ukraine |
| FG001 | Placebo Plus Pemetrexed | Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Randomised set uncut (RS): all patients who were randomised whether patients had received study treatment or not. Patients were allocated to the treatment groups as randomised, regardless of the actual medication taken.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nintedanib Plus Pemetrexed | Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. |
| BG001 | Placebo Plus Pemetrexed | Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) as Assessed by Central Independent Review | Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. | RS | Posted | Median | Inter-Quartile Range | months | From randomisation until cut-off date 9 July 2012 |
|
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| Secondary | Overall Survival (Key Secondary Endpoint) | Overall Survival (OS) defined as the duration from randomisation to death (irrespective of the reason of death). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. | RS | Posted | Median | Inter-Quartile Range | months | From randomisation until data cut-off (15 February 2013), Up to 30 months |
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| Secondary | Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review | Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. | RS | Posted | Median | Inter-Quartile Range | Months | From randomisation until data cut-off (15 February 2013), Up to 30 months |
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| Secondary | Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator | Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by investigator according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. | RS | Posted | Median | Inter-Quartile Range | Months | From randomisation until data cut-off (15 February 2013), Up to 30 months |
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| Secondary | Objective Tumor Response | Confirmed objective response is defined as confirmed Complete Response (CR) and Partial Response (PR) and evaluated according to the modified RECIST criteria version 1.0. This endpoint was analysed based on the central independent reviewer as well as the investigator | Randomised Set | Posted | Number | % of participants | From randomisation until data cut-off (15 February 2013), Up to 30 months |
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| Secondary | Duration of Confirmed Objective Tumour Response | The duration of objective response is the time from first documented (CR) or (PR) to the time of progression or death and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. This endpoint was analysed based on the central independent reviewer as well as the investigator. | RS | Posted | Median | Inter-Quartile Range | Months | From randomisation until data cut-off (15 February 2013), Up to 30 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Confirmed Objective Tumour Response | Time to confirmed objective response is defined as time from randomisation to the date of first documented (CR) or (PR) and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. This endpoint was analysed based on the central independent reviewer as well as the investigator. | RS | Posted | Median | Inter-Quartile Range | Months | From randomisation until data cut-off (15 February 2013), Up to 30 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control | Disease control was defined as a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and evaluated according to the modified RECIST criteria version 1.0. This endpoint was analysed based on the central independent reviewer as well as the investigator. | RS | Posted | Number | % of participants | From randomisation until data cut-off (15 February 2013), Up to 30 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Disease Control | The duration of disease control was defined as the time from randomisation to the date of disease progression or death (which ever occurs first) for patients with disease control. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. This endpoint was analysed based on the central independent reviewer as well as the investigator. | RS | Posted | Median | Inter-Quartile Range | Months | From randomisation until data cut-off (15 February 2013), Up to 30 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Tumour Size | Percentage change from baseline in tumour size is defined as decrease in the sum of the longest diameter of the target lesion. Presented means are in fact adjusted best means percentage changes generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no) This endpoint was analysed based on the central independent reviewer as well as the investigator. | RS | Posted | Mean | 95% Confidence Interval | percentage of change in tumor size in mm | From randomisation until data cut-off (15 February 2013), Up to 30 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Improvement. | Clinical improvement was defined as the time from randomisation to deterioration in body weight and/or Eastern Cooperative Oncology group performance score (ECOG PS) whichever occurred first. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. | RS | Posted | Median | Inter-Quartile Range | Months | From randomisation until data cut-off (15 February 2013), Up to 30 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life (QoL) | QoL was measured by standardised questionnaires (EQ-5D, EORTC QLQ-C30, EORTC QLQ-LC13). The EORTC QLQ-C30 comprises of 30 questions, using both multi-item scales and single-item measures. EORTC LC-13 comprises of 13 questions incorporating 1 multi-item scale and a series of single items. The following were the main points of interest: Time to deterioration of cough (QLQ-LC13 question 1), Time to deterioration of dyspnoea (QLQ-LC13, composite of questions 3 to 5), Time to deterioration of pain (QLQ- C30, composite of questions 9 and 19). Time to deterioration of cough, dyspnoea and pain was defined as the time to a 10-point increase from the baseline score. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. | RS | Posted | Median | Inter-Quartile Range | Months | From randomisation until data cut-off (15 February 2013), Up to 30 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide | Geometric mean of dose normalised predose plasma concentration (Cpre,ss,norm) of nintedanib and of its metabolites BIBF 1202 and BIBF 1202 glucuronide evaluated at steady state based on course 2 and 3. If only one value was available and valid, then this value was used for calculation of Cpre,ss,norm. | Pharmacokinetic set- all patients in the treated set who were documented to have received at least 1 dose of nintedanib and who had at least 1 valid drug plasma concentration available | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL/mg | Before the administration of nintedanib or placebo and between a window of 30 mins to an hour after administration of trial drug during Course 2 and between 1 and 3 hours after administration of trial drug during Course 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence and Intensity of Adverse Events | Incidence and intensity of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The worst CTCAE grade per patient is reported and MedDRA version 15.1 used. Serious signs and symptoms of progressive disease were reported as an adverse event in analysis of this endpoint. | Treated set uncut - all randomised patients who were documented to have taken at least 1 dose of study medication . Patients were allocated to the treatment groups according to the treatment actually received. | Posted | Number | % of participants | From the first drug administration until 28 days after the last drug administration, up to 36 months |
|
From the first drug administration until 28 days after the last drug administration, up to 36 months
One patient in the nintedanib plus pemetrexed treatment arm reported a serious adverse event for which the preferred term was not yet coded until data cut-off (15 February 2013).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nintedanib Plus Pemetrexed | Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. | 104 | 347 | 320 | 347 | ||
| EG001 | Placebo Plus Pemetrexed | Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. | 117 | 357 | 312 | 357 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Colonic obstruction | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Mass | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Spinal pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hepatocellular injury | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Amoebiasis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Infectious peritonitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Oropharyngeal candidiasis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Chemical injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Non-small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Pericardial effusion malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Tumour ulceration | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Central nervous system lesion | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Central nervous system necrosis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Affective disorder | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Renal injury | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Raynaud's phenomenon | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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Recruitment for the study was stopped early based on the results of a pre defined futility analysis.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C530716 | nintedanib |
| D000068437 | Pemetrexed |
| D014805 | Vitamin B 12 |
| D003907 | Dexamethasone |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013259 | Steroids, Fluorinated |
| D011622 | Pterins |
| D011621 | Pteridines |
Not provided
Not provided
| Male |
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| Units | Counts |
|---|---|
| Participants |
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Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
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Nintedanib 150 mg twice daily administered orally in a form of a soft gelatin capsule plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. |
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