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CompletedNCT02272413Updated Jan 13, 2020Results posted

Phase III Trial BI 695502 Plus Chemotherapy vs. Avastin® Plus Chemotherapy in Patients With Lung Cancer

A Phase 3 interventional study of BI 695502 and Avastin in Carcinoma, Non-Small-Cell Lung, sponsored by Boehringer Ingelheim. Completed at 189 sites in 28 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-13.

Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
671
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The objective of this phase III trial is to establish statistical equivalence in terms of efficacy (best overall response rate [ORR], proportion of patients with complete response [CR] plus partial response [PR]) until 18 weeks of first-line treatment with BI 695502 plus chemotherapy versus Avastin® plus chemotherapy followed by maintenance monotherapy with either BI 695502 or Avastin®.

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 671 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Adult patients aged >=18 years with histologically or cytologically confirmed advanced nonsquamous non-small cell lung cancer (nsNSCLC). Mixed tumors should be categorized according to the predominant histology.

Note: NSCLC should be predominantly nonsquamous. Recurrent or metastatic disease (Stage IV) with an indication for therapy with paclitaxel + carboplatin + Avastin®.

Patients harboring tumors with unknown or without activating epidermal growth factor receptor (EGFR) / anaplastic lymphoma receptor tyrosine kinase (ALK) mutation maybe included provided chemotherapy is standard of care. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on independent central review.

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.

Adequate hepatic, renal, and bone marrow function:

Life expectancy > 6 months based on clinical judgment. Further inclusion criteria apply.

Exclusion criteria

Exclusion criteria:

Prior therapy with monoclonal antibodies or small molecule inhibitors against Vascular Endothelial Growth Factor (VEGF) or VEGF receptors, including Avastin®.

Prior systemic therapy for metastatic disease. Prior systemic anticancer therapy or radiotherapy for locally advanced nsNSCLC if completed \<12 months prior to Screening.

Previous malignancy other than NSCLC in the last 5 years except for basal cell cancer of the skin or pre-invasive cancer of the cervix.

Symptomatic brain metastasis. Diagnosis of small cell carcinoma of the lung, squamous cell carcinoma of the lung, NSCLC not specified (NS) or NSCLC not otherwise specified(NOS).

Any unresolved toxicity > Common Toxicity Criteria Grade 1 (except alopecia) from previous anticancer therapy (including radiotherapy).

History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding. Thrombotic or hemorrhagic event =\< 6 months prior to Screening. Further exclusion criteria apply.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
671 participants (actual)

Study arms

  • Experimental
    BI 695502

    Drug: BI 695502

  • Active comparator
    Avastin

    Drug: Avastin

Interventions

  • DrugBI 695502
  • DrugAvastin
06

What researchers measure

Primary outcomes

  1. Best Overall Response Rate (ORR), Based on Unconfirmed Response Assessment, as Assessed by Central Imaging Review Until 18 Weeks After the Start of Treatment

    ORR was defined as the percentage of patients who achieved at least one visit response of complete response (CR) or partial response (PR) after the start of treatment. The response criteria evaluation was carried out according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. CR and PR did not need to be confirmed by a subsequent tumor assessment due to blinded central assessment. CR: Disappearance of all target lesions since baseline; PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Tumor assessments were performed prior to trial drug administration, until 18 weeks.

    Time frame: Tumor assessment scans were performed at baseline, Cycle 3 (Week 6), Cycle 5 (Week 12) and at Week 18 ±14 days. Best ORR evaluated until confirmed disease progression, unacceptable toxicity, death or up to 18 weeks, whichever happened earlier.

Secondary outcomes

  1. Percentage of Patients With Selected Treatment-Emergent Adverse Events (TEAEs) For Comparability Assessment of BI 695502 and US-licensed Avastin®

    The following selected adverse events (AEs) were evaluated for comparability assessment of BI 695502 and US-licensed Avastin®: * Infusion reactions (anaphylactic/hypersensitivity/infusion-related reactions), * Thromboembolic events (arterial or venous), * Febrile neutropenia, * Gastrointestinal perforations, * Hypertension, * Proteinuria, * Pulmonary hemorrhage, * Other hemorrhages (not including pulmonary hemorrhages), * Wound-healing complications/abscess/fistulas. The analysis of AEs was based on the concept of TEAEs. For non-switched patients, all AEs that started or worsened in severity on or after the first dose of trial drug and prior to the date of last administration of trial medication + 16 weeks inclusive were defined as TEAEs.

    Time frame: From first dose of trial drug until 16 weeks after the last dose of trial medication, up to 218 days.

  2. Progression-Free Survival (PFS) Time as Determined by Investigator Assessment

    PFS was defined as the time from randomization until disease progression as determined by Investigator assessment or death from any cause, whichever occurred first during the pre-switch period. Disease progression was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 millimeters. Tumor assessments were performed prior to trial drug administration. PFS was calculated using the Kaplan-Meier technique.

    Time frame: Tumor scans performed at baseline, Cycle 3 (Week 6), Cycle 5 (Week 12), Cycle 7 (Week 18), then every 3 cycles (~9 weeks) until confirmed disease progression. Analysis performed for pre-switch period only; maximum duration of up to 35 cycles (105 weeks).

  3. Overall Survival (OS) Time

    OS was defined as the time randomization until death from any cause during the pre-switch period. OS was calculated using the Kaplan-Meier technique.

    Time frame: From baseline until death due to any cause, ie., up to 35 cycles (105 weeks).

  4. Duration of Response (DOR) as Determined by Investigator Assessment

    DOR was the time from first documented CR or PR until time of progression as determined by Investigator assessment during the pre-switch period. Tumor assessments were performed prior to trial drug administration. DOR was calculated using the Kaplan-Meier technique.

    Time frame: Tumor scans performed at baseline, Cycle 3 (Week 6), Cycle 5 (Week 12), Cycle 7 (Week 18), then every 3 cycles (~9 weeks) until confirmed disease progression., ie up to 35 cycles (105 weeks).

07

Results

Posted Jan 13, 2020
Limitations and caveats
From 21 December 2017, after Week 18 primary analysis data cut-off, the Sponsor recommended to switch patients from BI 695502/US-licensed Avastin® to Avastin®. The main analyses to report all endpoint and AE results was the pre-switch period.

Participant flow

Phase III, randomized, double-blind, multicenter, active comparator, parallel 2-arm trial in patients with advanced non-squamous non-small cell lung cancer (nsNSCLC). From 21December2017, Sponsor recommended, patients to be switched from BI 695502 to reference product Avastin® (commercially available) as soon as it was available at clinical site.

Randomized Through Treatment Start
Participant flow — Randomized Through Treatment Start
MilestoneBI 695502Avastin® US
Started338333
Treated335328
Completed335328
Not completed35
Withdrew: Not treated35
Pre-switch Period
Participant flow — Pre-switch Period
MilestoneBI 695502Avastin® US
Started335328
Completed4246
Not completed293282
Withdrew: Adverse event3837
Withdrew: Death2626
Withdrew: Withdrawal by subject2715
Withdrew: Physician decision618
Withdrew: Progressive disease185173
Withdrew: Lost to follow-up02
Withdrew: Protocol violation10
Withdrew: Other than listed1011
Post-switch Period
Participant flow — Post-switch Period
MilestoneBI 695502Avastin® US
Started4246
Completed00
Not completed4246
Withdrew: Adverse event44
Withdrew: Death32
Withdrew: Withdrawal by subject12
Withdrew: Physician decision11
Withdrew: Progressive disease2121
Withdrew: Study terminated by sponsor811
Withdrew: Other than listed45

Outcome measures

PrimaryBest Overall Response Rate (ORR), Based on Unconfirmed Response Assessment, as Assessed by Central Imaging Review Until 18 Weeks After the Start of Treatment

ORR was defined as the percentage of patients who achieved at least one visit response of complete response (CR) or partial response (PR) after the start of treatment. The response criteria evaluation was carried out according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. CR and PR did not need to be confirmed by a subsequent tumor assessment due to blinded central assessment. CR: Disappearance of all target lesions since baseline; PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Tumor assessments were performed prior to trial drug administration, until 18 weeks.

Time frame:
Tumor assessment scans were performed at baseline, Cycle 3 (Week 6), Cycle 5 (Week 12) and at Week 18 ±14 days. Best ORR evaluated until confirmed disease progression, unacceptable toxicity, death or up to 18 weeks, whichever happened earlier.
Reported as:
Number · Percentage of patients (%)
Best Overall Response Rate (ORR), Based on Unconfirmed Response Assessment, as Assessed by Central Imaging Review Until 18 Weeks After the Start of Treatment
Percentage of patients (%)BI 695502Avastin® US
Best Overall Response Rate (ORR), Based on Unconfirmed Response Assessment, as Assessed by Central Imaging Review Until 18 Weeks After the Start of Treatment54.063.1
Statistical analysis
  • BI 695502 vs Avastin® US · Log-binomial regression · Ratio of best orr: 0.8550 · 90% CI 0.7697 to 0.9506
  • BI 695502 vs Avastin® US · Log-binomial regression · Ratio of best orr: 0.8550 · 95% CI 0.7543 to 0.9700
SecondaryPercentage of Patients With Selected Treatment-Emergent Adverse Events (TEAEs) For Comparability Assessment of BI 695502 and US-licensed Avastin®

The following selected adverse events (AEs) were evaluated for comparability assessment of BI 695502 and US-licensed Avastin®: * Infusion reactions (anaphylactic/hypersensitivity/infusion-related reactions), * Thromboembolic events (arterial or venous), * Febrile neutropenia, * Gastrointestinal perforations, * Hypertension, * Proteinuria, * Pulmonary hemorrhage, * Other hemorrhages (not including pulmonary hemorrhages), * Wound-healing complications/abscess/fistulas. The analysis of AEs was based on the concept of TEAEs. For non-switched patients, all AEs that started or worsened in severity on or after the first dose of trial drug and prior to the date of last administration of trial medication + 16 weeks inclusive were defined as TEAEs.

Time frame:
From first dose of trial drug until 16 weeks after the last dose of trial medication, up to 218 days.
Reported as:
Number · Percentage of patients (%)
Percentage of Patients With Selected Treatment-Emergent Adverse Events (TEAEs) For Comparability Assessment of BI 695502 and US-licensed Avastin®
Percentage of patients (%)BI 695502Avastin® US
AtLeast 1 AE selected for Comparability Assessment52.50 (47.04 to 57.99)45.10 (39.65 to 50.68)
Infusion reactions16.70 (12.88 to 21.15)13.10 (9.65 to 17.25)
Thromboembolic events6.60 (4.16 to 9.77)5.50 (3.28 to 8.53)
Febrile neutropenia3.90 (2.08 to 6.54)3.40 (1.69 to 5.92)
Gastrointestinal perforations2.10 (0.84 to 4.26)0.60 (0.07 to 2.19)
Hypertension15.50 (11.82 to 19.85)16.20 (12.34 to 20.60)
Proteinuria15.80 (12.08 to 20.18)14.60 (10.99 to 18.93)
Pulmonary haemorrhage1.20 (0.33 to 3.03)0.90 (0.19 to 2.65)
Other hemorrhages20.00 (15.85 to 24.69)16.20 (12.34 to 20.60)
Wound-healing complications/abscess/fistulas2.70 (1.24 to 5.04)2.10 (0.86 to 4.35)
Statistical analysis
  • BI 695502 vs Avastin® US · Score exact method · Risk ratio (rr): 1.16 · 95% CI 0.99 to 1.37
  • BI 695502 vs Avastin® US · Score exact method · Risk ratio (rr): 1.28 · 95% CI 0.88 to 1.88
  • BI 695502 vs Avastin® US · Score exact method · Risk ratio: 1.20 · 95% CI 0.64 to 2.32
  • BI 695502 vs Avastin® US · Score exact method · Risk ratio (rr): 1.16 · 95% CI 0.51 to 2.76
  • BI 695502 vs Avastin® US · Score exact method · Risk ratio (rr): 3.43 · 95% CI 0.79 to 32.82
  • BI 695502 vs Avastin® US · Score exact method · Risk ratio (rr): 0.96 · 95% CI 0.66 to 1.39
  • BI 695502 vs Avastin® US · Score exact method · Risk ratio (rr): 1.08 · 95% CI 0.74 to 1.57
  • BI 695502 vs Avastin® US · Score exact method · Risk ratio (rr): 1.31 · 95% CI 0.28 to 10.79
  • BI 695502 vs Avastin® US · Score exact method · Risk ratio (rr): 1.24 · 95% CI 0.88 to 1.74
  • BI 695502 vs Avastin® US · Score excat method · Risk ratio (rr): 1.26 · 95% CI 0.47 to 3.57
SecondaryProgression-Free Survival (PFS) Time as Determined by Investigator Assessment

PFS was defined as the time from randomization until disease progression as determined by Investigator assessment or death from any cause, whichever occurred first during the pre-switch period. Disease progression was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 millimeters. Tumor assessments were performed prior to trial drug administration. PFS was calculated using the Kaplan-Meier technique.

Time frame:
Tumor scans performed at baseline, Cycle 3 (Week 6), Cycle 5 (Week 12), Cycle 7 (Week 18), then every 3 cycles (~9 weeks) until confirmed disease progression. Analysis performed for pre-switch period only; maximum duration of up to 35 cycles (105 weeks).
Reported as:
Median · Months
Progression-Free Survival (PFS) Time as Determined by Investigator Assessment
MonthsBI 695502Avastin® US
Progression-Free Survival (PFS) Time as Determined by Investigator Assessment8.34 (7.49 to 8.77)9.00 (8.34 to 10.38)
Statistical analysis
  • BI 695502 vs Avastin® US · Cox-proportional hazards regression · Hazard ratio (hr): 1.22 · 95% CI 1.02 to 1.45
SecondaryOverall Survival (OS) Time

OS was defined as the time randomization until death from any cause during the pre-switch period. OS was calculated using the Kaplan-Meier technique.

Time frame:
From baseline until death due to any cause, ie., up to 35 cycles (105 weeks).
Reported as:
Median · Months
Overall Survival (OS) Time
MonthsBI 695502Avastin® US
Overall Survival (OS) Time15.57 (14.16 to 17.25)19.48 (15.87 to 20.73)
Statistical analysis
  • BI 695502 vs Avastin® US · Cox-proportional hazards regression · Hazard ratio (hr): 1.23 · 95% CI 1.00 to 1.51
SecondaryDuration of Response (DOR) as Determined by Investigator Assessment

DOR was the time from first documented CR or PR until time of progression as determined by Investigator assessment during the pre-switch period. Tumor assessments were performed prior to trial drug administration. DOR was calculated using the Kaplan-Meier technique.

Time frame:
Tumor scans performed at baseline, Cycle 3 (Week 6), Cycle 5 (Week 12), Cycle 7 (Week 18), then every 3 cycles (~9 weeks) until confirmed disease progression., ie up to 35 cycles (105 weeks).
Reported as:
Median · Months
Duration of Response (DOR) as Determined by Investigator Assessment
MonthsBI 695502Avastin® US
Duration of Response (DOR) as Determined by Investigator Assessment7.66 (7.03 to 9.03)8.94 (7.26 to 10.28)
Statistical analysis
  • BI 695502 vs Avastin® US · Cox-proportional hazards regression · Hazard ratio (hr): 1.14 · 95% CI 0.88 to 1.48

Adverse events

Collected over For Pre-switch period: From first dose of trial drug until 112 days (16 weeks) after the last dose of trial medication, up to 218 days. For post-switch period: From the first dose of Avastin® until end of treatment (EOT) visit, up to 127 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BI 695502 (Pre-switch)193/335 (57.6%)108/335 (32.2%)293/335 (87.5%)
US-licensed Avastin® (Pre-switch)184/328 (56.1%)89/328 (27.1%)288/328 (87.8%)
BI 695502 (Post-switch)3/42 (7.1%)5/42 (11.9%)20/42 (47.6%)
US-licensed Avastin® (Post-switch)2/46 (4.3%)2/46 (4.3%)22/46 (47.8%)
Most frequent serious events
Showing 10 of 179
Most frequent serious events
EventBI 695502 (Pre-switch)US-licensed Avastin® (Pre-switch)BI 695502 (Post-switch)US-licensed Avastin® (Post-switch)
Febrile neutropeniaBlood and lymphatic system disorders13/33511/3280/420/46
AnaemiaBlood and lymphatic system disorders6/33511/3280/420/46
Pulmonary embolismRespiratory, thoracic and mediastinal disorders11/3355/3280/420/46
PneumoniaInfections and infestations9/3359/3281/420/46
NeutropeniaBlood and lymphatic system disorders4/3359/3280/420/46
Acute myocardial infarctionCardiac disorders1/3350/3281/420/46
Pulmonary haemorrhageRespiratory, thoracic and mediastinal disorders3/3351/3281/420/46
SepsisInfections and infestations0/3350/3281/420/46
Cardiac tamponadeCardiac disorders0/3350/3281/420/46
Myocardial ischaemiaCardiac disorders0/3350/3281/420/46
Most frequent other events
Showing 10 of 43
Most frequent other events
EventBI 695502 (Pre-switch)US-licensed Avastin® (Pre-switch)BI 695502 (Post-switch)US-licensed Avastin® (Post-switch)
AlopeciaSkin and subcutaneous tissue disorders155/335149/3280/420/46
AnaemiaBlood and lymphatic system disorders112/33584/3282/424/46
NauseaGastrointestinal disorders73/33575/3282/421/46
ProteinuriaRenal and urinary disorders51/33546/3288/426/46
Neuropathy peripheralNervous system disorders62/33559/3281/420/46
NeutropeniaBlood and lymphatic system disorders61/33552/3280/422/46
DiarrhoeaGastrointestinal disorders60/33545/3281/421/46
Peripheral sensory neuropathyNervous system disorders56/33553/3280/421/46
VomitingGastrointestinal disorders56/33537/3281/421/46
Decreased appetiteMetabolism and nutrition disorders54/33554/3282/424/46

Baseline characteristics

Full Analysis Set (FAS): The FAS contained all randomized patients who received at least 1 dose of trial drug and who had a baseline tumor assessment.

Age, Continuous
Age, Continuous(Years)BI 695502Avastin® USTotal
Mean61.2 ± 9.8961.3 ± 9.2261.2 ± 9.55
Sex: Female, Male
Sex: Female, Male(Participants)BI 695502Avastin® USTotal
Female121125246
Male214203417
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)BI 695502Avastin® USTotal
Hispanic or Latino433477
Not Hispanic or Latino284285569
Unknown or Not Reported8917
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BI 695502Avastin® USTotal
American Indian or Alaska Native000
Asian6471135
Native Hawaiian or Other Pacific Islander000
Black or African American112
White258248506
More than one race000
Unknown or Not Reported12820
08

Study locations

189 sites
  • Pacific Cancer Medical Center, Inc.
    Anaheim, California 92801, United States
  • Comprehensive Blood and Cancer Center
    Bakersfield, California 93309, United States
  • Lalita Pandit, M.D., Inc.
    Fountain Valley, California 92708, United States
  • Southern California Oncology Research Alliance
    Los Angeles, California 90057, United States
  • Innovative Clinical Research, Inc.
    Whittier, California 90603, United States
  • Ashland Bellefonte Cancer Center
    Ashland, Kentucky 41101, United States
  • Reliant Medical Group
    Worcester, Massachusetts 01608, United States
  • Detroit Clinical Research Center
    Owosso, Michigan 48867, United States
  • Carolinas Cancer Care
    Charlotte, North Carolina 28204-2839, United States
  • CENIT - Centro de Neurociencias, Investigacion y Tratamiento
    Ciudad Autonoma Buenos Aires, C1125ABD, Argentina
  • Sanatorio Delta
    Rosario, S2000BIF, Argentina
  • Sanatorio Parque
    Rosario, S2000DSV, Argentina
  • Centro Oncológico de Rosario
    Rosario, S2000KZE, Argentina
  • CPCO - Centro de Pesquisa Clinica em Oncologia
    Cachoeiro de Itapemirim, 29308-014, Brazil
  • Hospital do Cancer do Ceara
    Fortaleza, 60430-230, Brazil
  • Pronutrir
    Fortaleza, 60810-180, Brazil
  • Hospital de Carida de de Ijui - CACON
    Ijuí, 98700-000, Brazil
  • Hospital Bruno Born
    Lajeado, 95900-000, Brazil
  • Hospital da Cidade de Passo Fundo
    Passo Fundo, 99010-260, Brazil
  • Universidade de Caxias do Sul - IPCEM - Inst. de Pesq.clilni
    Petrópolis, 95070-560, Brazil
  • Irmandade da Santa Casa de Misericórdia de Porto Alegre
    Porto Alegre, 90035-074, Brazil
  • Hospital de Clínicas de Porto Alegre
    Porto Alegre, 90035-903, Brazil
  • CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
    Santo André, 09060-650, Brazil
  • Clinica de Oncologia de Sorocaba
    Sorocaba, 18030-075, Brazil
  • ICAVC - Instituto do Cancer Arnaldo Vieira de Carvalho
    São Paulo, 01209-000, Brazil
  • ICESP - Instituto do Cancer do Estado de Sao Paulo
    São Paulo, 01246-000, Brazil
  • MHAT - Dobrich, AD
    Dobrich, 9300, Bulgaria
  • UMHAT Georgi Stranski, Clinic of Paediatrics, Pleven
    Pleven, 5800, Bulgaria
  • Complex Oncological Center - Plovdiv, EOOD
    Plovdiv, 4004, Bulgaria
  • DCC 1 - Ruse, EOOD
    Ruse, 7002, Bulgaria
  • MHAT Serdika, EOOD, Sofia
    Sofia, 1303, Bulgaria
  • MHAT 'Tokuda Hospital Sofia', EAD
    Sofia, 1407, Bulgaria
  • SHATOD 'Dr. Marko Antonov Markov'-Varna, EOOD
    Varna, 9010, Bulgaria
  • Clínica Santa María
    Santiago, 7520349, Chile
  • Hospital Clínico San Borja Arriarán
    Santiago, 8360160, Chile
  • Centro Internacional de Estudios Clinicos - CIEC
    Santiago, 8420383, Chile
  • Instituto Clínico Oncológico del Sur - ICOS
    Temuco, 4810469, Chile
  • Hospital Clinico Viña del Mar
    Viña del Mar, 1741, Chile
  • General Hospital Pula
    Pula, 52100, Croatia
  • Clinical Hospital Centar Sestre Milosrdnice
    Zagreb, 10000, Croatia
  • University Clinic for Pulmonary Diseases
    Zagreb, 10000, Croatia
  • Alexandria University Hospital
    Alexandria, 21131, Egypt
  • Ain Shams University Hospital
    Cairo, 11566, Egypt
  • National Cancer Institute, Cairo University
    Cairo, 11796, Egypt
  • Nasser Institute
    Cairo, 12655, Egypt
  • Oncology Centre- Mansoura University
    Mansoura, 1234, Egypt
  • Menofiya University Hospital
    Monofia, 31111, Egypt
  • Gesundheitszentrum Wetterau gGmbH
    Bad Nauheim, 61231, Germany
  • Athens Hospital of Chest Diseases "Sotiria"
    Athens, 11527, Greece
  • University General Hospital of Heraklion
    Crete, 71201, Greece
  • University of Patras Medical School
    Patras, 26504, Greece
  • Euromedica Kyanous Stavros General Hospital
    Thessaloniki, 54645, Greece
  • Health Center of Thermi, Thessaloniki
    Thessaloniki, 57001, Greece
  • Interbalkan Medical Center of Thessaloniki
    Thessaloniki, 57001, Greece
  • National Koranyi TBC and Pulm. Internal Med. Clinic
    Budapest, 1121, Hungary
  • Semmelweis University
    Budapest, 1125, Hungary
  • Pulmonology Institute of Veszprem County, Farkasgyepu
    Farkasgyepu, 8582, Hungary
  • Jasz-Nagykun-Szolnok Megyei Hetenyi G. Korhaz-Rendelointezet
    Szolnok, 5000, Hungary
  • Markusovszky University Teaching Hospital
    Szombathely, 9700, Hungary
  • Tudogyogyintezet Torokbalint
    Torokbalint, 2045, Hungary
  • ASST di Cremona
    Cremona, 26100, Italy
  • Osp. Umberto I
    Lugo (RA), 48022, Italy
  • Istituto Scientifico Romagnolo
    Meldola (FC), 47014, Italy
  • Azienda Ospedaliera Universitaria Pisana
    Pisa, 56124, Italy
  • Aichi Medical University Hospital
    Aichi, Nagakute, 480-1195, Japan
  • Aichi Cancer Center Aichi Hospital
    Aichi, Okazaki, 444-0011, Japan
  • Tosei General Hospital
    Aichi, Seto, 489-8642, Japan
  • Fujita Health University Hospital
    Aichi, Toyoake, 470-1192, Japan
  • Aso Co.,Ltd Iizuka Hospital
    Fukuoka, Iizuka, 820-8505, Japan
  • Gunma Prefectural Cancer Center
    Gunma, Ota, 373-8550, Japan
  • Hyogo Prefectural Amagasaki General Medical Center
    Hyogo, Amagasaki, 660-8550, Japan
  • Itami City Hospital
    Hyogo, Itami, 664-8540, Japan
  • Kobe City Medical Center General Hospital
    Hyogo, Kobe, 650-0047, Japan
  • Ibaraki Prefectural Central Hospital
    Ibaraki, Kasama, 309-1793, Japan
  • Kagawa Rosai Hospital
    Kagawa, Marugame, 763-8502, Japan
  • Kitasato University Hospital
    Kanagawa, Sagamihara, 252-0375, Japan
  • Yokohama City University Hospital
    Kanagawa, Yokohama, 236-0004, Japan
  • Uji-Tokushukai Medical Center
    Kyoto, Uji, 611-0041, Japan
  • Matsusaka City Hospital
    Mie, Matsusaka, 515-8544, Japan
  • Miyazaki Prefectural Miyazaki Hospital
    Miyazaki, Miyazaki, 880-8510, Japan
  • Nara Hospital Kinki University Faculty of Medicine
    Nara, Ikoma, 630-0293, Japan
  • Niigata Cancer Center Hospital
    Niigata, Niigata, 951-8566, Japan
  • Kansai Medical University Hospital
    Osaka, Hirakata, 573-1191, Japan
  • Osaka Medical Center for Cancer and Cardiovascular Diseases
    Osaka, Osaka, 537-8511, Japan
  • Takatsuki Red Cross Hospital
    Osaka, Takatsuki, 569-1096, Japan
  • Saitama Medical University International Medical Center
    Saitama, Hidaka, 350-1298, Japan
  • National Hospital Organization Kinki-Chuo Chest Medical Center
    Sakai-shi, 591-8555, Japan
  • Nippon Medical School Hospital
    Tokyo, Bunkyo-ku, 113-8603, Japan
  • Nihon University Itabashi Hospital
    Tokyo, Itabashi-ku, 173-8610, Japan
  • Japan Anti-Tuberculosis Association Fukujuji Hospital
    Tokyo, Kiyose, 204-8522, Japan
  • Toranomon Hospital
    Tokyo, Minato-ku, 105-8470, Japan
  • Chungbuk National University Hospital
    Cheongju-si, 361-711, Korea, Republic of
  • Chonnam National University Hwasun Hospital
    Hwasun-gun, 519-763, Korea, Republic of
  • Gachon University Gil Medical Center
    Incheon, 21565, Korea, Republic of
  • Asan Medical Center
    Seoul, 05505, Korea, Republic of
  • Korea University Guro Hospital
    Seoul, 08308, Korea, Republic of
  • The Catholic University of Korea, St.Vincent's Hospital
    Suwon-si, 16247, Korea, Republic of
  • Hospital Pulau Pinang
    Georgetown Pulau Pinang, 10990, Malaysia
  • University Malaya Medical Centre
    Kuala Lumpur, 59100, Malaysia
  • Hospital Tengku Ampuan Afzan
    Kuantan, 25100, Malaysia

Showing the first 100 of 189 sites across 28 countries.

09

References and documents

Study documents

  • Study protocol · Jan 17, 2018
  • Statistical analysis plan · Nov 13, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02272413
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Oct 23, 2014
Start date
Jul 8, 2015
Primary completion
Jun 30, 2017
Completion
Nov 16, 2018
Results posted
Jan 13, 2020
Last update
Jan 13, 2020

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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