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

December 26, 2019 updated by: Boehringer Ingelheim

A Multicenter, Randomized, Double-blind Phase III Trial to Evaluate Efficacy and Safety of BI 695502 Plus Chemotherapy Versus Avastin® Plus Chemotherapy in Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer

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®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

671

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina, C1125ABD
        • CENIT - Centro de Neurociencias, Investigacion y Tratamiento
      • Rosario, Argentina, S2000BIF
        • Sanatorio Delta
      • Rosario, Argentina, S2000DSV
        • Sanatorio Parque
      • Rosario, Argentina, S2000KZE
        • Centro Oncologico de Rosario
  • Brazil
      • Cachoeiro de Itapemirim, Brazil, 29308-014
        • CPCO - Centro de Pesquisa Clinica em Oncologia
      • Fortaleza, Brazil, 60430-230
        • Hospital do Cancer do Ceara
      • Fortaleza, Brazil, 60810-180
        • Pronutrir
      • Ijuí, Brazil, 98700-000
        • Hospital de Carida de de Ijui - CACON
      • Lajeado, Brazil, 95900-000
        • Hospital Bruno Born
      • Passo Fundo, Brazil, 99010-260
        • Hospital da Cidade de Passo Fundo
      • Petrópolis, Brazil, 95070-560
        • Universidade de Caxias do Sul - IPCEM - Inst. de Pesq.clilni
      • Porto Alegre, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre
      • Porto Alegre, Brazil, 90035-074
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
      • Santo André, Brazil, 09060-650
        • CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
      • Sorocaba, Brazil, 18030-075
        • Clinica de Oncologia de Sorocaba
      • São Paulo, Brazil, 01209-000
        • ICAVC - Instituto do Cancer Arnaldo Vieira de Carvalho
      • São Paulo, Brazil, 01246-000
        • Icesp - Instituto Do Câncer Do Estado de São Paulo
  • Bulgaria
      • Dobrich, Bulgaria, 9300
        • MHAT - Dobrich, AD
      • Pleven, Bulgaria, 5800
        • UMHAT Georgi Stranski, Clinic of Paediatrics, Pleven
      • Plovdiv, Bulgaria, 4004
        • Complex Oncological Center - Plovdiv, EOOD
      • Ruse, Bulgaria, 7002
        • DCC 1 - Ruse, EOOD
      • Sofia, Bulgaria, 1407
        • MHAT 'Tokuda Hospital Sofia', EAD
      • Sofia, Bulgaria, 1303
        • MHAT Serdika, EOOD, Sofia
      • Varna, Bulgaria, 9010
        • SHATOD 'Dr. Marko Antonov Markov'-Varna, EOOD
  • Chile
      • Santiago, Chile, 7520349
        • Clínica Santa María
      • Santiago, Chile, 8360160
        • Hospital Clinico San Borja Arriarán
      • Santiago, Chile, 8420383
        • Centro Internacional de Estudios Clinicos - CIEC
      • Temuco, Chile, 4810469
        • Instituto Clínico Oncológico del Sur - ICOS
      • Viña del Mar, Chile, 1741
        • Hospital Clinico Vina del Mar
  • Croatia
      • Pula, Croatia, 52100
        • General Hospital Pula
      • Zagreb, Croatia, 10000
        • University Clinic for Pulmonary Diseases
      • Zagreb, Croatia, 10000
        • Clinical Hospital Centar Sestre Milosrdnice
  • Egypt
      • Alexandria, Egypt, 21131
        • Alexandria University Hospital
      • Cairo, Egypt, 11566
        • Ain Shams University Hospital
      • Cairo, Egypt, 12655
        • Nasser Institute
      • Cairo, Egypt, 11796
        • National Cancer Institute, Cairo University
      • Mansoura, Egypt, 1234
        • Oncology Centre- Mansoura University
      • Monofia, Egypt, 31111
        • Menofiya University Hospital
  • Germany
      • Bad Nauheim, Germany, 61231
        • Gesundheitszentrum Wetterau gGmbH
  • Greece
      • Athens, Greece, 11527
        • Athens Hospital of Chest Diseases "Sotiria"
      • Crete, Greece, 71201
        • University General Hospital of Heraklion
      • Patras, Greece, 26504
        • University of Patras Medical School
      • Thessaloniki, Greece, 57001
        • Interbalkan Medical Center of Thessaloniki
      • Thessaloniki, Greece, 54645
        • Euromedica Kyanous Stavros General Hospital
      • Thessaloniki, Greece, 57001
        • Health Center of Thermi, Thessaloniki
  • Hungary
      • Budapest, Hungary, 1121
        • National Koranyi TBC and Pulm. Internal Med. Clinic
      • Budapest, Hungary, 1125
        • Semmelweis University
      • Farkasgyepu, Hungary, 8582
        • Pulmonology Institute of Veszprem County, Farkasgyepu
      • Szolnok, Hungary, 5000
        • Jasz-Nagykun-Szolnok Megyei Hetenyi G. Korhaz-Rendelointezet
      • Szombathely, Hungary, 9700
        • Markusovszky University Teaching Hospital
      • Torokbalint, Hungary, 2045
        • Tudogyogyintezet Torokbalint
  • Italy
      • Cremona, Italy, 26100
        • ASST di Cremona
      • Lugo (RA), Italy, 48022
        • Osp. Umberto I
      • Meldola (FC), Italy, 47014
        • Istituto Scientifico Romagnolo
      • Pisa, Italy, 56124
        • Azienda Ospedaliera Universitaria Pisana
  • Japan
      • Aichi, Nagakute, Japan, 480-1195
        • Aichi Medical University Hospital
      • Aichi, Okazaki, Japan, 444-0011
        • Aichi Cancer Center Aichi Hospital
      • Aichi, Seto, Japan, 489-8642
        • Tosei General Hospital
      • Aichi, Toyoake, Japan, 470-1192
        • Fujita Health University Hospital
      • Fukuoka, Iizuka, Japan, 820-8505
        • Aso Co.,Ltd Iizuka Hospital
      • Gunma, Ota, Japan, 373-8550
        • Gunma Prefectural Cancer Center
      • Hyogo, Amagasaki, Japan, 660-8550
        • Hyogo Prefectural Amagasaki General Medical Center
      • Hyogo, Itami, Japan, 664-8540
        • Itami City Hospital
      • Hyogo, Kobe, Japan, 650-0047
        • Kobe City Medical Center General Hospital
      • Ibaraki, Kasama, Japan, 309-1793
        • Ibaraki Prefectural Central Hospital
      • Kagawa, Marugame, Japan, 763-8502
        • Kagawa Rosai Hospital
      • Kanagawa, Sagamihara, Japan, 252-0375
        • Kitasato University Hospital
      • Kanagawa, Yokohama, Japan, 236-0004
        • Yokohama City University Hospital
      • Kyoto, Uji, Japan, 611-0041
        • Uji-Tokushukai Medical Center
      • Mie, Matsusaka, Japan, 515-8544
        • Matsusaka City Hospital
      • Miyazaki, Miyazaki, Japan, 880-8510
        • Miyazaki Prefectural Miyazaki Hospital
      • Nara, Ikoma, Japan, 630-0293
        • Nara Hospital Kinki University Faculty of Medicine
      • Niigata, Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
      • Osaka, Hirakata, Japan, 573-1191
        • Kansai Medical University Hospital
      • Osaka, Osaka, Japan, 537-8511
        • Osaka Medical Center for Cancer and Cardiovascular Diseases
      • Osaka, Takatsuki, Japan, 569-1096
        • Takatsuki Red Cross Hospital
      • Saitama, Hidaka, Japan, 350-1298
        • Saitama Medical University International Medical Center
      • Sakai-shi, Japan, 591-8555
        • National Hospital Organization Kinki-Chuo Chest Medical Center
      • Tokyo, Bunkyo-ku, Japan, 113-8603
        • Nippon Medical School Hospital
      • Tokyo, Itabashi-ku, Japan, 173-8610
        • Nihon University Itabashi Hospital
      • Tokyo, Kiyose, Japan, 204-8522
        • Japan Anti-Tuberculosis Association Fukujuji Hospital
      • Tokyo, Minato-ku, Japan, 105-8470
        • Toranomon Hospital
  • Korea, Republic of
      • Cheongju-si, Korea, Republic of, 361-711
        • Chungbuk National University Hospital
      • Hwasun-gun, Korea, Republic of, 519-763
        • Chonnam National University Hwasun Hospital
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital
      • Suwon-si, Korea, Republic of, 16247
        • The Catholic University of Korea, St.Vincent's hospital
  • Malaysia
      • Georgetown Pulau Pinang, Malaysia, 10990
        • Hospital Pulau Pinang
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
      • Kuantan, Malaysia, 25100
        • Hospital Tengku Ampuan Afzan
  • Mexico
      • El Salto, Mexico, 45680
        • Investigación Biomédica para el Desarrollo de Fármacos
      • Merida, Mexico, 97000
        • Unidad de Atencion Medica e Investigacion en Salud S.C.
      • Monterrey, Mexico, 64060
        • Axis Heilsa S. de R.L. de C.V., Monterrey
      • Orizaba, Mexico, 94300
        • Clinical Medical Research S.C
      • Queretaro, Mexico, 76090
        • Hospital San Jose Querétaro
      • Toluca, Mexico, 50080
        • Centro Hemato Oncologico Privado
  • Philippines
      • Bacolod City, Philippines, 6100
        • Dr. Pablo O. Torre Memorial Hospital
      • Cebu City, Philippines, 6000
        • Perpetual Succour Hospital (Cebu)
      • Cebu City, Philippines, 6000
        • Cebu Doctors Hospital
      • Manila, Philippines, 1000
        • Manila Doctors Hospital
      • Quezon City, Philippines, 1100
        • Lung Center Of The Philippines
  • Poland
      • Jelenia Gora, Poland, 58-506
        • Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
      • Lublin, Poland, 20-362
        • KO-MED Centra Kliniczne Lublin II
      • Tarnobrzeg, Poland, 39-400
        • Zofia Tarnowska domo Zamoyska,RegHosp.Cardiol.Dep,Tarnobrzeg
      • Torun, Poland, 87-100
        • The Provincial Polyclinical Hospital in Torun
      • Warszawa, Poland, 02-781
        • Onco.Cent. - Instit. of Maria Sklodowskiej-Curie
      • Warszawa, Poland, 04-125
        • Magodent Sp. Z o.o.
  • Portugal
      • Coimbra, Portugal, 3041-801
        • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
      • Lisboa, Portugal, 1769-001
        • Centro Hospitalar Lisboa Norte Hospital Pulido Valente
      • Porto, Portugal, 4200-072
        • IPO Porto Francisco Gentil, EPE
      • Santa Maria da Feira, Portugal, 4520-211
        • Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião
      • Vila Nova de Gaia, Portugal, 4434-502
        • Centro Hospitalar de Vila Nova de Gaia
  • Romania
      • Baia Mare, Romania, 430031
        • Baia Mare Emergency County Hospital
      • Bucuresti, Romania, 022328
        • Institute of Oncology 'Prof. Dr. Alexandru Trestioreanu'
      • Cluj Napoca, Romania, 400349
        • Spitalul Clinic Judetean de Urgenta Cluj Napoca
      • Cluj-Napoca, Romania, 400132
        • Spitalul Militar de Urgenta Dr.Papilian, Cluj-Napoca
      • Timisoara, Romania, 300210
        • S.C Oncocenter Oncologie Clinica S.R.L
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • SBIH of Arkhangelsk reg. "Arkhangelsk Clin. Onc. Dispensary"
      • Kazan, Russian Federation, 420029
        • St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"
      • Kursk, Russian Federation, 305035
        • RBIH "Kursk regional clinical oncology dispensary"
      • Moscow, Russian Federation, 115478
        • FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF
      • Omsk, Russian Federation, 644013
        • BHI of Omsk region - Clinical Oncology Dispensary
      • Pyatigorsk, Russian Federation, 357502
        • SBIH of Stavropol territory "Pyatigorsk Oncol. Dispensary"
      • St. Petersburg, Russian Federation, 197022
        • 1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.
      • St. Petersburg, Russian Federation, 197758
        • FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF
      • St. Petersburg, Russian Federation, 194291
        • GUZ Leningradskaya Regional Clin. Hospital, St. Petersburg
      • St. Petersburg, Russian Federation, 197022
        • SPb SBIH "City Clinical Oncological Dispensary"
  • Serbia
      • Belgrade, Serbia, 11080
        • Clinical Center Bezanijska kosa, Belgrade
      • Belgrade, Serbia, 11000
        • Institute for Oncol & Radiol of Serbia, Clinic f. Med. Onco.
      • Gornji Matejevac, Serbia, 18204
        • Clinic of Pulmonary Diseases and Tuberculosis 'Knez Selo'
      • Kragujevac, Serbia, 34000
        • Clinical Center Kragujevac
      • Sremska Kamenica, Serbia, 21204
        • Inst. for Pulm. Diseases of Vojvodine, Clinic f. Pulm. Oncol
  • South Africa
      • Cape Town, South Africa, 7570
        • GVI Cape Gate Oncology Centre
      • Cape town, South Africa, 7700
        • Rondebosch Oncology Centre
      • George, South Africa, 6530
        • GVI Oncology Outeniqua Unit
      • Johannesburg, South Africa, 1709
        • West Rand Oncology Centre, Johannesburg
      • Port Elizabeth, South Africa, 6045
        • Langenhoven Drive Oncology Centre
  • Spain
      • Badajoz, Spain, 06007
        • Hospital Infanta Cristina
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Santiago de Compostela, Spain, 15706
        • Hospital Clínico de Santiago
      • Sevilla, Spain, 41013
        • Hospital Virgen Del Rocio
      • Sevilla, Spain, 41014
        • Hospital Nuestra Señora de Valme
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncologia
      • Zaragoza, Spain, 50009
        • Hospital Miguel Servet
  • Thailand
      • Hat Yai, Thailand, 90110
        • Songklanagarind Hospital
      • Muang, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital
      • Muang, Thailand, 52000
        • Lampang Hospital
      • Muang, Thailand, 65000
        • Naresuan University Hospital
      • Muang, Thailand, 34000
        • Ubonratchathani Cancer Hospital, Muang
      • Muang, Thailand, 41330
        • Udonthani Cancer Hospital, Muang
  • Turkey
      • Antalya, Turkey, 7058
        • Akdeniz University Medical Faculty
      • Battalgazi, Turkey, 44280
        • Inonu Uni. Med. Fac., Battalgazi
      • Diyarbakir, Turkey, 21080
        • Dicle University Medical Faculty
      • Edirne, Turkey, 22030
        • Trakya Universitesi Tip Fakultesi
      • Gaziantep, Turkey, 27310
        • Gaziantep University
      • Istanbul, Turkey, 34093
        • Bezmi Alem Foundation University Medical Faculty Hospital
      • Istanbul, Turkey, 34752
        • Yeditepe University Medical School Hospital
      • Istanbul, Turkey, 34844
        • Fatih University Faculty of Medicince, Istanbul
  • Ukraine
      • Chernihiv, Ukraine, 14029
        • CTPI Chernihiv Regional Oncological Dispensary, Chernihiv
      • Dnipropetrovsk, Ukraine, 49102
        • Munic.Instit."City Clin.Hosp.#4" of Dnipro City Council
      • Kharkiv, Ukraine, 61070
        • CHI Kharkiv Regional Clinical Oncological Center
      • Kherson, Ukraine, 73000
        • Kherson Regional Oncologic Dispensary, Kherson
      • Kirovohrad, Ukraine, 25006
        • Treatment-Diagnostic CTR of Private Enterprise, Kirovohrad
      • Kryvyi Rih, Dnipropetrovsk, Ukraine, 50048
        • CI Kryvyi Rih Oncological Dispensary of DRC
      • Kyiv, Ukraine, 03022
        • National Institute of Cancer
      • Lutsk, Ukraine, 43018
        • Medical and Preventive Treatment Inst. Volyn Regional, Lutsk
      • Lviv, Ukraine, 79031
        • CI of LRC Lviv Onco.Reg.Treat.&Diag.Cent.
      • Poltava, Ukraine, 38011
        • Poltava Regional Clinical Oncological Dispensary, Poltava
      • Sumy, Ukraine, 40005
        • Sumy Regional Oncology Center
      • Ternopil, Ukraine, 46023
        • CI of TRC Ternopil RC Oncological Dispensary Thoracic Dept
      • Uzhgorod, Ukraine, 88000
        • Uzhgorod National University, Oncology Centre
      • Uzhgorod, Ukraine, 88014
        • Transcarpathian Reg Clin Oncological Dispensary, Uzhgorod
      • Vinnytsia, Ukraine, 21029
        • Vinnytsia Regional Clinical Oncological Dispensary
      • Zhaporizhzhia, Ukraine, 69040
        • CI Zapor Reg Cl Oncological Dispensary of ZRC, Zhaporizhzhia
  • United Kingdom
      • Cheltenham, United Kingdom, GL53 7AN
        • Cheltenham General Hospital
      • Manchester, United Kingdom, M23 9LT
        • Wythenshawe Hospital
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Pacific Cancer Medical Center, Inc.
      • Bakersfield, California, United States, 93309
        • Comprehensive Blood and Cancer Center
      • Fountain Valley, California, United States, 92708
        • Lalita Pandit, M.D., Inc.
      • Los Angeles, California, United States, 90057
        • Southern California Oncology Research Alliance
      • Whittier, California, United States, 90603
        • Innovative Clinical Research, Inc.
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • Ashland Bellefonte Cancer Center
    • Massachusetts
      • Worcester, Massachusetts, United States, 01608
        • Reliant Medical Group
    • Michigan
      • Owosso, Michigan, United States, 48867
        • Detroit Clinical Research Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204-2839
        • Carolinas Cancer Care
  • Vietnam
      • Can Tho, Vietnam, 000000
        • Cần Thơ Oncology Hospital
      • Hanoi, Vietnam, 100000
        • Bach Mai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Avastin
Drug: Avastin
Experimental: BI 695502
Drug: BI 695502

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Overall Response Rate (ORR), Based on Unconfirmed Response Assessment, as Assessed by Central Imaging Review Until 18 Weeks After the Start of Treatment
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.
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Selected Treatment-Emergent Adverse Events (TEAEs) For Comparability Assessment of BI 695502 and US-licensed Avastin®
Time Frame: From first dose of trial drug until 16 weeks after the last dose of trial medication, up to 218 days.

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.
From first dose of trial drug until 16 weeks after the last dose of trial medication, up to 218 days.
Progression-Free Survival (PFS) Time as Determined by Investigator Assessment
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).
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.
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).
Overall Survival (OS) Time
Time Frame: From baseline until death due to any cause, ie., up to 35 cycles (105 weeks).
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.
From baseline until death due to any cause, ie., up to 35 cycles (105 weeks).
Duration of Response (DOR) as Determined by Investigator Assessment
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).
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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2015

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

November 16, 2018

Study Registration Dates

First Submitted

October 21, 2014

First Submitted That Met QC Criteria

October 21, 2014

First Posted (Estimate)

October 23, 2014

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

December 26, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1302.5
  • 2014-002161-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carcinoma, Non-Small-Cell Lung

Clinical Trials on Avastin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe