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AzTrials

Carcinoma, Non-Small-Cell LungPhase 3NCT02272413

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

A Phase 3 study testing BI 695502 and Avastin in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 189 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
BI 695502 and Avastin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
671 participants
Where
189 sitesin 28 countries
Study dates
8 Jul 2015to 16 Nov 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

189 sites in 28 countries.

189 sites in 28 countries

Japan27 sites

  • Aichi Medical University Hospital

    Aichi, Nagakute, 480-1195

  • Aichi Cancer Center Aichi Hospital

    Aichi, Okazaki, 444-0011

  • Tosei General Hospital

    Aichi, Seto, 489-8642

  • Fujita Health University Hospital

    Aichi, Toyoake, 470-1192

  • Aso Co.,Ltd Iizuka Hospital

    Fukuoka, Iizuka, 820-8505

  • Gunma Prefectural Cancer Center

    Gunma, Ota, 373-8550

  • Hyogo Prefectural Amagasaki General Medical Center

    Hyogo, Amagasaki, 660-8550

  • Itami City Hospital

    Hyogo, Itami, 664-8540

  • Kobe City Medical Center General Hospital

    Hyogo, Kobe, 650-0047

  • Ibaraki Prefectural Central Hospital

    Ibaraki, Kasama, 309-1793

  • Kagawa Rosai Hospital

    Kagawa, Marugame, 763-8502

  • Kitasato University Hospital

    Kanagawa, Sagamihara, 252-0375

  • Yokohama City University Hospital

    Kanagawa, Yokohama, 236-0004

  • Uji-Tokushukai Medical Center

    Kyoto, Uji, 611-0041

  • Matsusaka City Hospital

    Mie, Matsusaka, 515-8544

  • Miyazaki Prefectural Miyazaki Hospital

    Miyazaki, Miyazaki, 880-8510

  • Nara Hospital Kinki University Faculty of Medicine

    Nara, Ikoma, 630-0293

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 951-8566

  • Kansai Medical University Hospital

    Osaka, Hirakata, 573-1191

  • Osaka Medical Center for Cancer and Cardiovascular Diseases

    Osaka, Osaka, 537-8511

  • Takatsuki Red Cross Hospital

    Osaka, Takatsuki, 569-1096

  • Saitama Medical University International Medical Center

    Saitama, Hidaka, 350-1298

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Sakaishi, 591-8555

  • Nippon Medical School Hospital

    Tokyo, Bunkyo-ku, 113-8603

  • Nihon University Itabashi Hospital

    Tokyo, Itabashi-ku, 173-8610

  • Japan Anti-Tuberculosis Association Fukujuji Hospital

    Tokyo, Kiyose, 204-8522

  • Toranomon Hospital

    Tokyo, Minato-ku, 105-8470

Other trials in Japan

Ukraine16 sites

  • CTPI Chernihiv Regional Oncological Dispensary, Chernihiv

    Chernihiv, 14029

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

    Dnipropetrovsk, 49102

  • CHI Kharkiv Regional Clinical Oncological Center

    Kharkiv, 61070

  • Kherson Regional Oncologic Dispensary, Kherson

    Kherson, 73000

  • Treatment-Diagnostic CTR of Private Enterprise, Kirovohrad

    Kirovohrad, 25006

  • CI Kryvyi Rih Oncological Dispensary of DRC

    Kryvyi Rih, Dnipropetrovsk, 50048

  • National Institute of Cancer

    Kyiv, 03022

  • Medical and Preventive Treatment Inst. Volyn Regional, Lutsk

    Lutsk, 43018

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

    Lviv, 79031

  • Poltava Regional Clinical Oncological Dispensary, Poltava

    Poltava, 38011

  • Sumy Regional Oncology Center

    Sumy, 40005

  • CI of TRC Ternopil RC Oncological Dispensary Thoracic Dept

    Ternopil, 46023

  • Uzhgorod National University, Oncology Centre

    Uzhhorod, 88000

  • Transcarpathian Reg Clin Oncological Dispensary, Uzhgorod

    Uzhhorod, 88014

  • Vinnytsia Regional Clinical Oncological Dispensary

    Vinnytsia, 21029

  • CI Zapor Reg Cl Oncological Dispensary of ZRC, Zhaporizhzhia

    Zhaporizhzhia, 69040

Other trials in Ukraine

Brazil13 sites

  • CPCO - Centro de Pesquisa Clinica em Oncologia

    Cachoeiro de Itapemirim, 29308-014

  • Hospital do Cancer do Ceara

    Fortaleza, 60430-230

  • Pronutrir

    Fortaleza, 60810-180

  • Hospital de Carida de de Ijui - CACON

    Ijuí, 98700-000

  • Hospital Bruno Born

    Lajeado, 95900-000

  • Hospital da Cidade de Passo Fundo

    Passo Fundo, 99010-260

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

    Petrópolis, 95070-560

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, 90035-074

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, 90035-903

  • CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

    Santo André, 09060-650

  • ICAVC - Instituto do Cancer Arnaldo Vieira de Carvalho

    São Paulo, 01209-000

  • ICESP - Instituto do Cancer do Estado de Sao Paulo

    São Paulo, 01246-000

  • Clinica de Oncologia de Sorocaba

    Sorocaba, 18030-075

Other trials in Brazil

Russia10 sites

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

    Arkhangelsk, 163045

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

    Kazan', 420029

  • RBIH "Kursk regional clinical oncology dispensary"

    Kursk, 305035

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

    Moscow, 115478

  • BHI of Omsk region - Clinical Oncology Dispensary

    Omsk, 644013

  • SBIH of Stavropol territory "Pyatigorsk Oncol. Dispensary"

    Pyatigorsk, 357502

  • GUZ Leningradskaya Regional Clin. Hospital, St. Petersburg

    Saint Petersburg, 194291

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

    Saint Petersburg, 197022

  • SPb SBIH "City Clinical Oncological Dispensary"

    Saint Petersburg, 197022

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

    Saint Petersburg, 197758

Other trials in Russia

United States9 sites

  • Pacific Cancer Medical Center, Inc.

    Anaheim, California, 92801

  • Ashland Bellefonte Cancer Center

    Ashland, Kentucky, 41101

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • Carolinas Cancer Care

    Charlotte, North Carolina, 28204-2839

  • Lalita Pandit, M.D., Inc.

    Fountain Valley, California, 92708

  • Southern California Oncology Research Alliance

    Los Angeles, California, 90057

  • Detroit Clinical Research Center

    Owosso, Michigan, 48867

  • Innovative Clinical Research, Inc.

    Whittier, California, 90603

  • Reliant Medical Group

    Worcester, Massachusetts, 01608

Other trials in United States

Spain8 sites

  • Hospital Infanta Cristina

    Badajoz, 06007

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital La Paz

    Madrid, 28046

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706

  • Hospital Virgen del Rocío

    Seville, 41013

  • Hospital Nuestra Señora de Valme

    Seville, 41014

  • Instituto Valenciano de Oncología

    Valencia, 46009

  • Hospital Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Turkey (Türkiye)8 sites

  • Akdeniz University Medical Faculty

    Antalya, 7058

  • Inonu Uni. Med. Fac., Battalgazi

    Battalgazi, 44280

  • Dicle University Medical Faculty

    Diyarbakır, 21080

  • Trakya Universitesi Tip Fakultesi

    Edirne, 22030

  • Gaziantep University

    Gaziantep, 27310

  • Bezmi Alem Foundation University Medical Faculty Hospital

    Istanbul, 34093

  • Yeditepe University Medical School Hospital

    Istanbul, 34752

  • Fatih University Faculty of Medicince, Istanbul

    Istanbul, 34844

Other trials in Turkey (Türkiye)

Bulgaria7 sites

  • MHAT - Dobrich, AD

    Dobrich, 9300

  • UMHAT Georgi Stranski, Clinic of Paediatrics, Pleven

    Pleven, 5800

  • Complex Oncological Center - Plovdiv, EOOD

    Plovdiv, 4004

  • DCC 1 - Ruse, EOOD

    Rousse, 7002

  • MHAT Serdika, EOOD, Sofia

    Sofia, 1303

  • MHAT 'Tokuda Hospital Sofia', EAD

    Sofia, 1407

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

    Varna, 9010

Other trials in Bulgaria

Egypt6 sites

  • Oncology Centre- Mansoura University

    Al Mansurah, 1234

  • Alexandria University Hospital

    Alexandria, 21131

  • Ain Shams University Hospital

    Cairo, 11566

  • National Cancer Institute, Cairo University

    Cairo, 11796

  • Nasser Institute

    Cairo, 12655

  • Menofiya University Hospital

    Monofia, 31111

Other trials in Egypt

Greece6 sites

  • Athens Hospital of Chest Diseases "Sotiria"

    Athens, 11527

  • University General Hospital of Heraklion

    Crete, 71201

  • University of Patras Medical School

    Pátrai, 26504

  • Euromedica Kyanous Stavros General Hospital

    Thessaloniki, 54645

  • Health Center of Thermi, Thessaloniki

    Thessaloniki, 57001

  • Interbalkan Medical Center of Thessaloniki

    Thessaloniki, 57001

Other trials in Greece

Hungary6 sites

  • National Koranyi TBC and Pulm. Internal Med. Clinic

    Budapest, 1121

  • Semmelweis University

    Budapest, 1125

  • Pulmonology Institute of Veszprem County, Farkasgyepu

    Farkasgyepű, 8582

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

    Szolnok, 5000

  • Markusovszky University Teaching Hospital

    Szombathely, 9700

  • Tudogyogyintezet Torokbalint

    Törökbálint, 2045

Other trials in Hungary

Mexico6 sites

  • Investigacion Biomedica para el Desarrollo de Farmacos

    El Salto, 45680

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

    Mérida, 97000

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

    Monterrey, 64060

  • Clinical Medical Research S.C

    Orizaba, 94300

  • Hospital San Jose Querétaro

    Querétaro, 76090

  • Centro Hemato Oncológico Privado

    Toluca, 50080

Other trials in Mexico

Poland6 sites

  • Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej

    Jelenia Góra, 58-506

  • KO-MED Centra Kliniczne Lublin II

    Lublin, 20-362

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

    Tarnobrzeg, 39-400

  • The Provincial Polyclinical Hospital in Torun

    Torun, 87-100

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

    Warsaw, 02-781

  • Magodent Sp. Z o.o.

    Warsaw, 04-125

Other trials in Poland

South Korea6 sites

  • Chungbuk National University Hospital

    Cheongju-si, 361-711

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, 519-763

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Asan Medical Center

    Seoul, 05505

  • Korea University Guro Hospital

    Seoul, 08308

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

    Suwon, 16247

Other trials in South Korea

Thailand6 sites

  • Songklanagarind Hospital

    Hat Yai, 90110

  • Ubonratchathani Cancer Hospital, Muang

    Muang, 34000

  • Udonthani Cancer Hospital, Muang

    Muang, 41330

  • Maharaj Nakorn Chiang Mai Hospital

    Muang, 50200

  • Lampang Hospital

    Muang, 52000

  • Naresuan University Hospital

    Muang, 65000

Other trials in Thailand

Chile5 sites

  • Clínica Santa María

    Santiago, 7520349

  • Hospital Clínico San Borja Arriarán

    Santiago, 8360160

  • Centro Internacional de Estudios Clinicos - CIEC

    Santiago, 8420383

  • Instituto Clínico Oncológico del Sur - ICOS

    Temuco, 4810469

  • Hospital Clinico Viña del Mar

    Viña del Mar, 1741

Other trials in Chile

Philippines5 sites

  • Dr. Pablo O. Torre Memorial Hospital

    Bacolod City, 6100

  • Cebu Doctors Hospital

    Cebu City, 6000

  • Perpetual Succour Hospital (Cebu)

    Cebu City, 6000

  • Manila Doctors Hospital

    Manila, 1000

  • Lung Center of the Philippines

    Quezon City, 1100

Other trials in Philippines

Portugal5 sites

  • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

    Coimbra, 3041-801

  • Centro Hospitalar Lisboa Norte Hospital Pulido Valente

    Lisbon, 1769-001

  • IPO Porto Francisco Gentil, EPE

    Porto, 4200-072

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

    Santa Maria da Feira, 4520-211

  • Centro Hospitalar de Vila Nova de Gaia

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Romania5 sites

  • Baia Mare Emergency County Hospital

    Baia Mare, 430031

  • Institute of Oncology 'Prof. Dr. Alexandru Trestioreanu'

    Bucharest, 022328

  • Spitalul Militar de Urgenta Dr.Papilian, Cluj-Napoca

    Cluj-Napoca, 400132

  • Spitalul Clinic Judetean de Urgenta Cluj Napoca

    Cluj-Napoca, 400349

  • S.C Oncocenter Oncologie Clinica S.R.L

    Timișoara, 300210

Other trials in Romania

Serbia5 sites

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

    Belgrade, 11000

  • Clinical Center Bezanijska kosa, Belgrade

    Belgrade, 11080

  • Clinic of Pulmonary Diseases and Tuberculosis 'Knez Selo'

    Gornji Matejevac, 18204

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

    Kamenitz, 21204

  • Clinical Center Kragujevac

    Kragujevac, 34000

Other trials in Serbia

South Africa5 sites

  • GVI Cape Gate Oncology Centre

    Cape Town, 7570

  • Rondebosch Oncology Centre

    Cape Town, 7700

  • GVI Oncology Outeniqua Unit

    George, 6530

  • West Rand Oncology Centre, Johannesburg

    Johannesburg, 1709

  • Langenhoven Drive Oncology Centre

    Port Elizabeth, 6045

Other trials in South Africa

Argentina4 sites

  • CENIT - Centro de Neurociencias, Investigacion y Tratamiento

    Ciudad Autonoma Buenos Aires, C1125ABD

  • Sanatorio Delta

    Rosario, S2000BIF

  • Sanatorio Parque

    Rosario, S2000DSV

  • Centro Oncológico de Rosario

    Rosario, S2000KZE

Other trials in Argentina

Italy4 sites

  • ASST di Cremona

    Cremona, 26100

  • Osp. Umberto I

    Lugo (RA), 48022

  • Istituto Scientifico Romagnolo

    Meldola (FC), 47014

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56124

Other trials in Italy

Croatia3 sites

  • General Hospital Pula

    Pula, 52100

  • Clinical Hospital Centar Sestre Milosrdnice

    Zagreb, 10000

  • University Clinic for Pulmonary Diseases

    Zagreb, 10000

Other trials in Croatia

Malaysia3 sites

  • Hospital Pulau Pinang

    Georgetown Pulau Pinang, 10990

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100

Other trials in Malaysia

United Kingdom2 sites

  • Cheltenham General Hospital

    Cheltenham, GL53 7AN

  • Wythenshawe Hospital

    Manchester, M23 9LT

Other trials in United Kingdom

Vietnam2 sites

  • Can Tho Oncology Hospital

    Can Tho, 000000

  • Bach Mai hospital

    Hanoi, 100000

Other trials in Vietnam

Germany1 site

  • Gesundheitszentrum Wetterau gGmbH

    Bad Nauheim, 61231

Other trials in Germany

About this study

Official title: 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®.

Being tested
BI 695502, Avastin
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 695502Drug

  • AvastinDrug

Study groups in NCT02272413
Study groupRoleWhat they receive
BI 695502ExperimentalNot described
Receives: Drug: BI 695502
AvastinActive comparatorNot described
Receives: Drug: Avastin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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 (4)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2014 (estimated)
  2. Study start8 Jul 2015
  3. Primary completion30 Jun 2017
  4. Study completion16 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
671 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02272413
Sponsor's protocol ID
1302.5
Other IDs
2014-002161-30, 2014
Status last verified
Dec 2019
First submitted
21 Oct 2014
Last updated
13 Jan 2020

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BI 695502 and Avastin in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 189 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 189 sites in Japan, Ukraine, Brazil, Russia, United States and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02272413.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.

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