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

NCT ID: NCT02272413

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 671 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-08
• Study Completion Date: 2018-11-16

Brief 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®.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BI 695502

Group Type: EXPERIMENTAL

BI 695502

Intervention Type: DRUG

Avastin

Group Type: ACTIVE_COMPARATOR

Avastin

Intervention Type: DRUG

Interventions

BI 695502

Intervention Type: DRUG

Avastin

Intervention Type: DRUG

Eligibility Criteria

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:

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Pacific Cancer Medical Center, Inc.

Anaheim, California, United States

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Lalita Pandit, M.D., Inc.

Fountain Valley, California, United States

Southern California Oncology Research Alliance

Los Angeles, California, United States

Innovative Clinical Research, Inc.

Whittier, California, United States

Ashland Bellefonte Cancer Center

Ashland, Kentucky, United States

Reliant Medical Group

Worcester, Massachusetts, United States

Detroit Clinical Research Center

Owosso, Michigan, United States

Carolinas Cancer Care

Charlotte, North Carolina, United States

CENIT - Centro de Neurociencias, Investigacion y Tratamiento

Ciudad Autonoma Buenos Aires, , Argentina

Sanatorio Delta

Rosario, , Argentina

Sanatorio Parque

Rosario, , Argentina

Centro Oncológico de Rosario

Rosario, , Argentina

CPCO - Centro de Pesquisa Clinica em Oncologia

Cachoeiro de Itapemirim, , Brazil

Hospital do Cancer do Ceara

Fortaleza, , Brazil

Pronutrir

Fortaleza, , Brazil

Hospital de Carida de de Ijui - CACON

Ijuí, , Brazil

Hospital Bruno Born

Lajeado, , Brazil

Hospital da Cidade de Passo Fundo

Passo Fundo, , Brazil

Universidade de Caxias do Sul - IPCEM - Inst. de Pesq.clilni

Petrópolis, , Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, , Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, , Brazil

CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

Santo André, , Brazil

ICAVC - Instituto do Cancer Arnaldo Vieira de Carvalho

São Paulo, , Brazil

ICESP - Instituto do Cancer do Estado de Sao Paulo

São Paulo, , Brazil

Clinica de Oncologia de Sorocaba

Sorocaba, , Brazil

MHAT - Dobrich, AD

Dobrich, , Bulgaria

UMHAT Georgi Stranski, Clinic of Paediatrics, Pleven

Pleven, , Bulgaria

Complex Oncological Center - Plovdiv, EOOD

Plovdiv, , Bulgaria

DCC 1 - Ruse, EOOD

Rousse, , Bulgaria

MHAT Serdika, EOOD, Sofia

Sofia, , Bulgaria

MHAT 'Tokuda Hospital Sofia', EAD

Sofia, , Bulgaria

SHATOD 'Dr. Marko Antonov Markov'-Varna, EOOD

Varna, , Bulgaria

Clínica Santa María

Santiago, , Chile

Hospital Clínico San Borja Arriarán

Santiago, , Chile

Centro Internacional de Estudios Clinicos - CIEC

Santiago, , Chile

Instituto Clínico Oncológico del Sur - ICOS

Temuco, , Chile

Hospital Clinico Viña del Mar

Viña del Mar, , Chile

General Hospital Pula

Pula, , Croatia

Clinical Hospital Centar Sestre Milosrdnice

Zagreb, , Croatia

University Clinic for Pulmonary Diseases

Zagreb, , Croatia

Oncology Centre- Mansoura University

Al Mansurah, , Egypt

Alexandria University Hospital

Alexandria, , Egypt

Ain Shams University Hospital

Cairo, , Egypt

National Cancer Institute, Cairo University

Cairo, , Egypt

Nasser Institute

Cairo, , Egypt

Menofiya University Hospital

Monofia, , Egypt

Gesundheitszentrum Wetterau gGmbH

Bad Nauheim, , Germany

Athens Hospital of Chest Diseases "Sotiria"

Athens, , Greece

University General Hospital of Heraklion

Crete, , Greece

University of Patras Medical School

Pátrai, , Greece

Euromedica Kyanous Stavros General Hospital

Thessaloniki, , Greece

Health Center of Thermi, Thessaloniki

Thessaloniki, , Greece

Interbalkan Medical Center of Thessaloniki

Thessaloniki, , Greece

National Koranyi TBC and Pulm. Internal Med. Clinic

Budapest, , Hungary

Semmelweis University

Budapest, , Hungary

Pulmonology Institute of Veszprem County, Farkasgyepu

Farkasgyepű, , Hungary

Jasz-Nagykun-Szolnok Megyei Hetenyi G. Korhaz-Rendelointezet

Szolnok, , Hungary

Markusovszky University Teaching Hospital

Szombathely, , Hungary

Tudogyogyintezet Torokbalint

Törökbálint, , Hungary

ASST di Cremona

Cremona, , Italy

Osp. Umberto I

Lugo (RA), , Italy

Istituto Scientifico Romagnolo

Meldola (FC), , Italy

Azienda Ospedaliera Universitaria Pisana

Pisa, , Italy

Aichi Medical University Hospital

Aichi, Nagakute, , Japan

Aichi Cancer Center Aichi Hospital

Aichi, Okazaki, , Japan

Tosei General Hospital

Aichi, Seto, , Japan

Fujita Health University Hospital

Aichi, Toyoake, , Japan

Aso Co.,Ltd Iizuka Hospital

Fukuoka, Iizuka, , Japan

Gunma Prefectural Cancer Center

Gunma, Ota, , Japan

Hyogo Prefectural Amagasaki General Medical Center

Hyogo, Amagasaki, , Japan

Itami City Hospital

Hyogo, Itami, , Japan

Kobe City Medical Center General Hospital

Hyogo, Kobe, , Japan

Ibaraki Prefectural Central Hospital

Ibaraki, Kasama, , Japan

Kagawa Rosai Hospital

Kagawa, Marugame, , Japan

Kitasato University Hospital

Kanagawa, Sagamihara, , Japan

Yokohama City University Hospital

Kanagawa, Yokohama, , Japan

Uji-Tokushukai Medical Center

Kyoto, Uji, , Japan

Matsusaka City Hospital

Mie, Matsusaka, , Japan

Miyazaki Prefectural Miyazaki Hospital

Miyazaki, Miyazaki, , Japan

Nara Hospital Kinki University Faculty of Medicine

Nara, Ikoma, , Japan

Niigata Cancer Center Hospital

Niigata, Niigata, , Japan

Kansai Medical University Hospital

Osaka, Hirakata, , Japan

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka, Osaka, , Japan

Takatsuki Red Cross Hospital

Osaka, Takatsuki, , Japan

Saitama Medical University International Medical Center

Saitama, Hidaka, , Japan

National Hospital Organization Kinki-Chuo Chest Medical Center

Sakaishi, , Japan

Nippon Medical School Hospital

Tokyo, Bunkyo-ku, , Japan

Nihon University Itabashi Hospital

Tokyo, Itabashi-ku, , Japan

Japan Anti-Tuberculosis Association Fukujuji Hospital

Tokyo, Kiyose, , Japan

Toranomon Hospital

Tokyo, Minato-ku, , Japan

Hospital Pulau Pinang

Georgetown Pulau Pinang, , Malaysia

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Hospital Tengku Ampuan Afzan

Kuantan, , Malaysia

Investigacion Biomedica para el Desarrollo de Farmacos

El Salto, , Mexico

Unidad de Atencion Medica e Investigacion en Salud S.C.

Mérida, , Mexico

Axis Heilsa S. de R.L. de C.V., Monterrey

Monterrey, , Mexico

Clinical Medical Research S.C

Orizaba, , Mexico

Hospital San Jose Querétaro

Querétaro, , Mexico

Centro Hemato Oncológico Privado

Toluca, , Mexico

Dr. Pablo O. Torre Memorial Hospital

Bacolod City, , Philippines

Cebu Doctors Hospital

Cebu City, , Philippines

Perpetual Succour Hospital (Cebu)

Cebu City, , Philippines

Manila Doctors Hospital

Manila, , Philippines

Lung Center of the Philippines

Quezon City, , Philippines

Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej

Jelenia Góra, , Poland

KO-MED Centra Kliniczne Lublin II

Lublin, , Poland

Zofia Tarnowska domo Zamoyska,RegHosp.Cardiol.Dep,Tarnobrzeg

Tarnobrzeg, , Poland

The Provincial Polyclinical Hospital in Torun

Torun, , Poland

Onco.Cent. - Instit. of Maria Sklodowskiej-Curie

Warsaw, , Poland

Magodent Sp. Z o.o.

Warsaw, , Poland

CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

Coimbra, , Portugal

Centro Hospitalar Lisboa Norte Hospital Pulido Valente

Lisbon, , Portugal

IPO Porto Francisco Gentil, EPE

Porto, , Portugal

Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião

Santa Maria da Feira, , Portugal

Centro Hospitalar de Vila Nova de Gaia

Vila Nova de Gaia, , Portugal

Baia Mare Emergency County Hospital

Baia Mare, , Romania

Institute of Oncology 'Prof. Dr. Alexandru Trestioreanu'

Bucharest, , Romania

Spitalul Militar de Urgenta Dr.Papilian, Cluj-Napoca

Cluj-Napoca, , Romania

Spitalul Clinic Judetean de Urgenta Cluj Napoca

Cluj-Napoca, , Romania

S.C Oncocenter Oncologie Clinica S.R.L

Timișoara, , Romania

SBIH of Arkhangelsk reg. "Arkhangelsk Clin. Onc. Dispensary"

Arkhangelsk, , Russia

St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"

Kazan', , Russia

RBIH "Kursk regional clinical oncology dispensary"

Kursk, , Russia

FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF

Moscow, , Russia

BHI of Omsk region - Clinical Oncology Dispensary

Omsk, , Russia

SBIH of Stavropol territory "Pyatigorsk Oncol. Dispensary"

Pyatigorsk, , Russia

GUZ Leningradskaya Regional Clin. Hospital, St. Petersburg

Saint Petersburg, , Russia

1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.

Saint Petersburg, , Russia

SPb SBIH "City Clinical Oncological Dispensary"

Saint Petersburg, , Russia

FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF

Saint Petersburg, , Russia

Institute for Oncol & Radiol of Serbia, Clinic f. Med. Onco.

Belgrade, , Serbia

Clinical Center Bezanijska kosa, Belgrade

Belgrade, , Serbia

Clinic of Pulmonary Diseases and Tuberculosis 'Knez Selo'

Gornji Matejevac, , Serbia

Inst. for Pulm. Diseases of Vojvodine, Clinic f. Pulm. Oncol

Kamenitz, , Serbia

Clinical Center Kragujevac

Kragujevac, , Serbia

GVI Cape Gate Oncology Centre

Cape Town, , South Africa

Rondebosch Oncology Centre

Cape Town, , South Africa

GVI Oncology Outeniqua Unit

George, , South Africa

West Rand Oncology Centre, Johannesburg

Johannesburg, , South Africa

Langenhoven Drive Oncology Centre

Port Elizabeth, , South Africa

Chungbuk National University Hospital

Cheongju-si, , South Korea

Chonnam National University Hwasun Hospital

Hwasun-gun, , South Korea

Gachon University Gil Medical Center

Incheon, , South Korea

Asan Medical Center

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

The Catholic University of Korea, St.Vincent's Hospital

Suwon, , South Korea

Hospital Infanta Cristina

Badajoz, , Spain

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Hospital La Paz

Madrid, , Spain

Hospital Clínico de Santiago

Santiago de Compostela, , Spain

Hospital Virgen del Rocío

Seville, , Spain

Hospital Nuestra Señora de Valme

Seville, , Spain

Instituto Valenciano de Oncología

Valencia, , Spain

Hospital Miguel Servet

Zaragoza, , Spain

Songklanagarind Hospital

Hat Yai, , Thailand

Ubonratchathani Cancer Hospital, Muang

Muang, , Thailand

Udonthani Cancer Hospital, Muang

Muang, , Thailand

Maharaj Nakorn Chiang Mai Hospital

Muang, , Thailand

Lampang Hospital

Muang, , Thailand

Naresuan University Hospital

Muang, , Thailand

Akdeniz University Medical Faculty

Antalya, , Turkey (Türkiye)

Inonu Uni. Med. Fac., Battalgazi

Battalgazi, , Turkey (Türkiye)

Dicle University Medical Faculty

Diyarbakır, , Turkey (Türkiye)

Trakya Universitesi Tip Fakultesi

Edirne, , Turkey (Türkiye)

Gaziantep University

Gaziantep, , Turkey (Türkiye)

Bezmi Alem Foundation University Medical Faculty Hospital

Istanbul, , Turkey (Türkiye)

Yeditepe University Medical School Hospital

Istanbul, , Turkey (Türkiye)

Fatih University Faculty of Medicince, Istanbul

Istanbul, , Turkey (Türkiye)

CTPI Chernihiv Regional Oncological Dispensary, Chernihiv

Chernihiv, , Ukraine

Munic.Instit."City Clin.Hosp.#4" of Dnipro City Council

Dnipropetrovsk, , Ukraine

CHI Kharkiv Regional Clinical Oncological Center

Kharkiv, , Ukraine

Kherson Regional Oncologic Dispensary, Kherson

Kherson, , Ukraine

Treatment-Diagnostic CTR of Private Enterprise, Kirovohrad

Kirovohrad, , Ukraine

CI Kryvyi Rih Oncological Dispensary of DRC

Kryvyi Rih, Dnipropetrovsk, , Ukraine

National Institute of Cancer

Kyiv, , Ukraine

Medical and Preventive Treatment Inst. Volyn Regional, Lutsk

Lutsk, , Ukraine

CI of LRC Lviv Onco.Reg.Treat.&Diag.Cent.

Lviv, , Ukraine

Poltava Regional Clinical Oncological Dispensary, Poltava

Poltava, , Ukraine

Sumy Regional Oncology Center

Sumy, , Ukraine

CI of TRC Ternopil RC Oncological Dispensary Thoracic Dept

Ternopil, , Ukraine

Uzhgorod National University, Oncology Centre

Uzhhorod, , Ukraine

Transcarpathian Reg Clin Oncological Dispensary, Uzhgorod

Uzhhorod, , Ukraine

Vinnytsia Regional Clinical Oncological Dispensary

Vinnytsia, , Ukraine

CI Zapor Reg Cl Oncological Dispensary of ZRC, Zhaporizhzhia

Zhaporizhzhia, , Ukraine

Cheltenham General Hospital

Cheltenham, , United Kingdom

Wythenshawe Hospital

Manchester, , United Kingdom

Can Tho Oncology Hospital

Can Tho, , Vietnam

Bach Mai hospital

Hanoi, , Vietnam

Countries

United States; Argentina; Brazil; Bulgaria; Chile; Croatia; Egypt; Germany; Greece; Hungary; Italy; Japan; Malaysia; Mexico; Philippines; Poland; Portugal; Romania; Russia; Serbia; South Africa; South Korea; Spain; Thailand; Turkey (Türkiye); Ukraine; United Kingdom; Vietnam

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2014-002161-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1302.5

Identifier Type: -

Identifier Source: org_study_id