AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 4NCT00949910

An Expanded Access Program of Tarceva (Erlotinib) in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)

A Phase 4 study testing Erlotinib in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 543 sites in 51 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

This study will provide treatment with erlotinib to participants with advanced NSCLC who have received at least one course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Erlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,586 participants
Where
543 sitesin 51 countries
Study dates
Nov 2004to Apr 2009
Phase
Phase 4
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

  • Adults greater than or equal to (≥) 18 years of age
  • Histologically or cytologically documented inoperable, locally advanced, metastatic, or recurrent NSCLC
  • Previous treatment with no more than 2 prior chemotherapy regimens

Who cannot join

  • Previous systemic anti-cancer therapy with human epidermal growth factor receptor 1 (HER1)/epidermal growth factor receptor (EGFR) inhibitors
  • Inability to take oral medication
  • Any other malignancies within 5 years

Trial locations and contacts

543 sites in 51 countries.

543 sites in 51 countries

Italy57 sites

  • Study site

    Ancona, 60121

  • Study site

    Avellino, 83100

  • Study site

    Aviano, 33081

  • Study site

    Bari, 70124

  • Study site

    Benevento, 82100

  • Study site

    Bergamo, 24128

  • Study site

    Bollate, 20021

  • Study site

    Bologna, 40138

  • Study site

    Bologna, 40139

  • Study site

    Brescia, 25123

  • Study site

    Candiolo, 10060

  • Study site

    Catania, 95100

  • Study site

    Catanzaro, 88100

  • Study site

    Cosenza, 87100

  • Study site

    Cuneo, 12100

  • Study site

    Fabriano, 60044

  • Study site

    Feltre - Bl, 32032

  • Study site

    Florence, 50139

  • Study site

    Genova, 16132

  • Study site

    La Spezia, 19100

  • Study site

    Lido di Camaiore, 55043

  • Study site

    Livorno, 57100

  • Study site

    Meldola, 47014

  • Study site

    Messina, 98123

  • Study site

    Milan, 20133

  • Study site

    Milan, 20157

  • Study site

    Milan, 20162

  • Study site

    Mirano, 30035

  • Study site

    Modena, 41100

  • Study site

    Naples, 80131

  • Study site

    Naples

  • Study site

    Nuoro, 081100

  • Study site

    Orbassano, 10043

  • Study site

    Palermo, 90123

  • Study site

    Palermo, 90127

  • Study site

    Parma, 43100

  • Study site

    Pavia, 27100

  • Study site

    Perugia, 06122

  • Study site

    Pescara, 65124

  • Study site

    Pisa, 56100

  • Study site

    Rionero in Vulture, 85028

  • Study site

    Roma, 00144

  • Study site

    Roma, 00152

  • Study site

    Roma, 00157

  • Study site

    Roma, 00168

  • Study site

    Roma, 00186

  • Study site

    Roma, 00189

  • Study site

    Salerno, 80124

  • Study site

    Salerno, 84131

  • Study site

    San Giovanni Rotondo, 71013

  • Study site

    Sassari, 07100

  • Study site

    Siena, 53100

  • Study site

    Sondrio, 23100

  • Study site

    Taormina, 98030

  • Study site

    Torino, 10126

  • Study site

    Trento, 38100

  • Study site

    Udine, 33100

Other trials in Italy

Germany54 sites

  • Study site

    Amberg, 92224

  • Study site

    Augsburg, 86150

  • Study site

    Aurich, 26603

  • Study site

    Bad Berka, 99437

  • Study site

    Berlin, 12203

  • Study site

    Berlin, 13125

  • Study site

    Berlin, 13353

  • Study site

    Bonn, 53113

  • Study site

    Celle, 29221

  • Study site

    Cologne, 50677

  • Study site

    Cologne, 51109

  • Study site

    Dortmund, 44137

  • Study site

    Dresden, 01219

  • Study site

    Essen, 45122

  • Study site

    Flensburg, 24939

  • Study site

    Frankfurt, 60488

  • Study site

    Frankfurt am Main, 65929

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Gauting, 82131

  • Study site

    Gerlingen, 70839

  • Study site

    Giessen, 35392

  • Study site

    Großhansdorf, 22927

  • Study site

    Halle, 06120

  • Study site

    Hamburg, 20246

  • Study site

    Hamburg, 22767

  • Study site

    Heidelberg, 69126

  • Study site

    Herne, 44625

  • Study site

    Homburg/Saar, 66424

  • Study site

    Kassel, 34125

  • Study site

    Koblenz, 56073

  • Study site

    Leipzig, 04207

  • Study site

    Leverkusen, 51375

  • Study site

    Lostau, 39291

  • Study site

    Löwenstein, 74245

  • Study site

    Lübeck, 23562

  • Study site

    Mainz, 55101

  • Study site

    Mannheim, 68167

  • Study site

    Minden, 32429

  • Study site

    Mönchengladbach, 41063

  • Study site

    München, 80336

  • Study site

    München, 81675

  • Study site

    München, 81737

  • Study site

    Neuruppin, 16816

  • Study site

    Nuremberg, 90419

  • Study site

    Oldenburg, 26121

  • Study site

    Osnabrück, 49076

  • Study site

    Rostock, 18055

  • Study site

    Saarbrücken, 66113

  • Study site

    Trier, 54290

  • Study site

    Ulm, 89081

  • Study site

    Wangen, 88239

  • Study site

    Wiesbaden, 65199

  • Study site

    Wuppertal, 42283

  • Study site

    Würselen, 52146

Other trials in Germany

Brazil45 sites

  • Study site

    Belo Horizonte, 30140-083

  • Study site

    Belo Horizonte, 30150-221

  • Study site

    Belo Horizonte, 30150-320

  • Study site

    Belo Horizonte, 30180-061

  • Study site

    Brasília, 70390-150

  • Study site

    Brasília, 70710-904

  • Study site

    Campinas, 13073-400

  • Study site

    Campinas, 13084-759

  • Study site

    Caxias do Sul, 95020-450

  • Study site

    Curitiba, 80440-080

  • Study site

    Curitiba, 80530-010

  • Study site

    Curitiba, 80730-180

  • Study site

    Fortaleza, 60125-151

  • Study site

    Fortaleza, 60336-550

  • Study site

    Fortaleza, 60741-420

  • Study site

    Ijuí, 98700-000

  • Study site

    Jaú, 17210-080

  • Study site

    João Pessoa, 58040280

  • Study site

    Porto Alegre, 90035-001

  • Study site

    Porto Alegre, 90110-270

  • Study site

    Porto Alegre, 90480-003

  • Study site

    Porto Alegre, 90610-000

  • Study site

    Recife, 52012-220

  • Study site

    Ribeirão Preto, 14025-430

  • Study site

    Rio de Janeiro, 22031072

  • Study site

    Rio de Janeiro, 22260-020

  • Study site

    Rio de Janeiro, 22359-900

  • Study site

    Rio de Janeiro, 22410-003

  • Study site

    Salvador, 40170-110

  • Study site

    Salvador, 41810-012

  • Study site

    Salvador, 41950-610

  • Study site

    Santos, 11075-350

  • Study site

    São Paulo, 01232-010

  • Study site

    São Paulo, 01308-000

  • Study site

    São Paulo, 01308-050

  • Study site

    São Paulo, 01332-000

  • Study site

    São Paulo, 01406100

  • Study site

    São Paulo, 01509-010

  • Study site

    São Paulo, 01509-900

  • Study site

    São Paulo, 04002-030

  • Study site

    São Paulo, 04122-000

  • Study site

    São Paulo, 04521-022

  • Study site

    São Paulo, 05401-400

  • Study site

    São Paulo, 05651-901

  • Study site

    Sorocaba, 18035-300

Other trials in Brazil

Netherlands41 sites

  • Study site

    's-Hertogenbosch, 5211 RW

  • Study site

    Alkmaar, 1815 JD

  • Study site

    Amersfoort, 3818 ES

  • Study site

    Amstelveen, 1186 AH

  • Study site

    Amsterdam, 1007 MB

  • Study site

    Amsterdam, 1061 AE

  • Study site

    Amsterdam, 1066 CX

  • Study site

    Amsterdam, 1091 AC

  • Study site

    Amsterdam, 1105 AZ

  • Study site

    Arnhem, 6815 AD

  • Study site

    Assen, 9401 RK

  • Study site

    Beverwijk, 1942 LE

  • Study site

    Boxmeer, 5831 HA

  • Study site

    Breda, 4819 EV

  • Study site

    Capelle Ad Yssel, 2906 ZC

  • Study site

    Drachten, 9202 NN

  • Study site

    Eindhoven, 5623 EJ

  • Study site

    Enschede, 7513 ER

  • Study site

    Flushing, 4382 EE

  • Study site

    Groningen, 9713 GZ

  • Study site

    Groningen, 9728 NZ

  • Study site

    Haarlem, 2035 RC

  • Study site

    Harderwijk, 3844 DG

  • Study site

    Heerlen, 6419 PC

  • Study site

    Helmond, 5700 AB

  • Study site

    Hengelo, 7555 DL

  • Study site

    Hoofddorp, 2134 TM

  • Study site

    Leiden, 2333 ZA

  • Study site

    Leiderdorp, 2353 GA

  • Study site

    Maastricht, 6229 HX

  • Study site

    Nieuwegein, 3435 CM

  • Study site

    Nijmegen, 6532 SZ

  • Study site

    Roermond, 6043 CV

  • Study site

    Rotterdam, 3045 PM

  • Study site

    Sliedrecht, 3361 XV

  • Study site

    The Hague, 2504 LN

  • Study site

    Veldhoven, 5504 DB

  • Study site

    Venlo, 5912 BL

  • Study site

    Vlaardingen, 3136 LA

  • Study site

    Zaandam, 1502 DV

  • Study site

    Zwolle, 8011 JW

Other trials in Netherlands

Belgium38 sites

  • Study site

    Aalst, 9300

  • Study site

    Antwerp, 2018

  • Study site

    Antwerp, 2020

  • Study site

    Antwerp, 2060

  • Study site

    Arlon, 6700

  • Study site

    Baudour, 7331

  • Study site

    Blankenberge, 8370

  • Study site

    Borgerhout, 2140

  • Study site

    Boussu, 7360

  • Study site

    Brasschaat, 2930

  • Study site

    Brussels, 1000

  • Study site

    Brussels, 1020

  • Study site

    Brussels, 1070

  • Study site

    Brussels, 1090

  • Study site

    Brussels, 1200

  • Study site

    Charleroi, 6000

  • Study site

    Edegem, 2650

  • Study site

    Genk, 3600

  • Study site

    Ghent, 9000

  • Study site

    Gilly, 6060

  • Study site

    Godinne, 5530

  • Study site

    Gosselies, 6041

  • Study site

    Haine-Saint-Paul, 7100

  • Study site

    Hasselt, 3500

  • Study site

    Kortrijk, 8500

  • Study site

    Libramont, 6800

  • Study site

    Liège, 4000

  • Study site

    Mons, 7000

  • Study site

    Namur, 5000

  • Study site

    Ostend, 8400

  • Study site

    Ottignies, 1340

  • Study site

    Oudenaarde, 9700

  • Study site

    Roeselare, 8800

  • Study site

    Sint-Niklaas, 9100

  • Study site

    Tielt, 8700

  • Study site

    Tournai, 7500

  • Study site

    Turnhout, 2300

  • Study site

    Wilrijk, 2610

Other trials in Belgium

Mexico35 sites

  • Study site

    Acapulco, 39850

  • Study site

    Chihuahua City, 31000

  • Study site

    Chihuahua City, 31238

  • Study site

    Guadalajara, 44220

  • Study site

    Guadalajara, 44340

  • Study site

    Juárez, 32310

  • Study site

    León, 37000

  • Study site

    León, 37160

  • Study site

    Matamoros, 87300

  • Study site

    Mérida, 97070

  • Study site

    Mérida, 97150

  • Study site

    Mexicali, 21100

  • Study site

    Mexico City, 01120

  • Study site

    Mexico City, 03100

  • Study site

    Mexico City, 06700

  • Study site

    Mexico City, 06720

  • Study site

    Mexico City, 07360

  • Study site

    Mexico City, 11850

  • Study site

    Mexico City, 14050

  • Study site

    Mexico City, 14080

  • Study site

    Mexico City, 72530

  • Study site

    Mexico City, 89400

  • Study site

    Monterrey, 64020

  • Study site

    Monterrey, 64060

  • Study site

    Monterrey, 64320

  • Study site

    Monterrey, 64380

  • Study site

    Obregón, 85000

  • Study site

    Obregón, 85100

  • Study site

    Puebla City, 72530

  • Study site

    San Luis Potosí City, 78230

  • Study site

    Tampico, 89120

  • Study site

    Tijuana, 22320

  • Study site

    Toluca, 52140

  • Study site

    Torreón, 27200

  • Study site

    Zapopan, 44349

Other trials in Mexico

South Korea24 sites

  • Study site

    Bundang City, 463-802

  • Study site

    Busan, 602-715

  • Study site

    Cheonan, 330-715

  • Study site

    Daegu, 700-712

  • Study site

    Daegu, 700-721

  • Study site

    Daegu, 705-717

  • Study site

    Daejeon, 301-721

  • Study site

    Gwangju, 501-757

  • Study site

    Iksan, 570-711

  • Study site

    Incheon, 400-711

  • Study site

    Kyunggi-do, 411-769

  • Study site

    Pusan, 602-702

  • Study site

    Pusan, 602-739

  • Study site

    Pusan, 614-735

  • Study site

    Seoul, 133-792

  • Study site

    Seoul, 135-170

  • Study site

    Seoul, 135-720

  • Study site

    Seoul, 136-705

  • Study site

    Seoul, 137-040

  • Study site

    Seoul, 138-736

  • Study site

    Seoul, 139-706

  • Study site

    Seoul, 158-710

  • Study site

    Seoul, 405-760

  • Study site

    Suwon, 442-721

Other trials in South Korea

Australia18 sites

  • Study site

    Adelaide, 5011

  • Study site

    Camperdown, 2050

  • Study site

    Chermside, 4032

  • Study site

    Frankston, 3199

  • Study site

    Fremantle, 6160

  • Study site

    Geelong, 3220

  • Study site

    Kurralta Park, 5037

  • Study site

    Malvern, 3144

  • Study site

    Melbourne, 3002

  • Study site

    Melbourne, 3084

  • Study site

    Perth, 6009

  • Study site

    St Leonards, 2065

  • Study site

    Sydney, 2031

  • Study site

    Sydney, 2217

  • Study site

    Tugun, 4224

  • Study site

    Waratah, 2298

  • Study site

    Wodonga, 3690

  • Study site

    Wollongong, 2500

Other trials in Australia

Austria18 sites

  • Study site

    Bludesch, 6712

  • Study site

    Grimmenstein, 2840

  • Study site

    Innsbruck, 6020

  • Study site

    Klagenfurt, 9010

  • Study site

    Kufstein, 6330

  • Study site

    Leoben, 8700

  • Study site

    Linz, 4010

  • Study site

    Linz, 4020

  • Study site

    Natters, 6161

  • Study site

    Oberpullendorf, 7350

  • Study site

    Salzburg, 5020

  • Study site

    Vienna, 1090

  • Study site

    Vienna, 1130

  • Study site

    Vienna, 1140

  • Study site

    Vienna, 1145

  • Study site

    Vienna, 1160

  • Study site

    Wels, 4600

  • Study site

    Zams, 6511

Other trials in Austria

Russia17 sites

  • Study site

    Barnaul, 656049

  • Study site

    Kazan', 420029

  • Study site

    Kazan', 420111

  • Study site

    Krasnodar, 350040

  • Study site

    Krasnodar

  • Study site

    Moscow, 107005

  • Study site

    Moscow, 115478

  • Study site

    Moscow, 143423

  • Study site

    Obninsk, 249036

  • Study site

    Saint Petersburg, 197022

  • Study site

    Saint Petersburg, 197758

  • Study site

    Samara, 443031

  • Study site

    Smolensk, 214000

  • Study site

    Stavropol, 355047

  • Study site

    Tyumen, 625047

  • Study site

    Ufa, 450054

  • Study site

    Volgograd, 400138

Other trials in Russia

China15 sites

  • Study site

    Beijing, 100021

  • Study site

    Beijing, 100053

  • Study site

    Beijing, 100730

  • Study site

    Beijing, 101149

  • Study site

    Chengdu, 610041

  • Study site

    Guangzhou, 510060

  • Study site

    Guangzhou, 510080

  • Study site

    Hangzhou, 310022

  • Study site

    Harbin, 150040

  • Study site

    Nanjing, 210002

  • Study site

    Shanghai, 200030

  • Study site

    Shanghai, 200032

  • Study site

    Shanghai, 200433

  • Study site

    Tianjin, 300060

  • Study site

    Wuhan, 430030

Other trials in China

Israel15 sites

  • Study site

    Ashkelon, 78306

  • Study site

    Beersheba, 8410101

  • Study site

    Haifa, 34354

  • Study site

    Haifa, 35152

  • Study site

    Holon, 58100

  • Study site

    Jerusalem, 91031

  • Study site

    Jerusalem, 91120

  • Study site

    Kfar Saba, 44281

  • Study site

    Nahariya, 22100

  • Study site

    Petah Tikva, 49100

  • Study site

    Ramat Gan, 52621

  • Study site

    Rehovot, 76100

  • Study site

    Safed, 13110

  • Study site

    Tel Aviv, 6423906

  • Study site

    Tsrifin, 70300

Other trials in Israel

Taiwan14 sites

  • Study site

    Changhua, 500

  • Study site

    Kaohsiung City, 00833

  • Study site

    Kaohsiung City, 807

  • Study site

    Kaohsiung City, 813

  • Study site

    Taichung, 404

  • Study site

    Taichung, 407

  • Study site

    Tainan, 704

  • Study site

    Tainan, 710

  • Study site

    Taipei, 00112

  • Study site

    Taipei, 104

  • Study site

    Taipei, 106

  • Study site

    Taipei, 112

  • Study site

    Taipei, 114

  • Study site

    Taoyuan, 333

Other trials in Taiwan

Finland10 sites

  • Study site

    Hämeenlinna, 13530

  • Study site

    Helsinki, 00150

  • Study site

    Helsinki, 00290

  • Study site

    Joensuu, 80210

  • Study site

    Kuopio, 70211

  • Study site

    Oulu, 90029

  • Study site

    Pori, 28500

  • Study site

    Tampere, 33520

  • Study site

    Turku, 20520

  • Study site

    Vaasa, 65130

Other trials in Finland

Romania10 sites

  • Study site

    Alba Iulia, 510073

  • Study site

    Baia Mare

  • Study site

    Bucharest, 010816

  • Study site

    Bucharest, 022328

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca, 400015

  • Study site

    Oradea

  • Study site

    Sibiu

  • Study site

    Suceava

  • Study site

    Timișoara, 1900

Other trials in Romania

Turkey (Türkiye)10 sites

  • Study site

    Ankara, 06018

  • Study site

    Ankara, 06100

  • Study site

    Ankara, 06500

  • Study site

    Ankara, 06590

  • Study site

    Istanbul, 34300

  • Study site

    Istanbul, 34890

  • Study site

    Istanbul

  • Study site

    Izmir, 35100

  • Study site

    Izmir, 35340

  • Study site

    Shhiye, Ankara, 06100

Other trials in Turkey (Türkiye)

Argentina9 sites

  • Study site

    Buenos Aires, 1272

  • Study site

    Buenos Aires, 1427

  • Study site

    Buenos Aires, 1437

  • Study site

    Buenos Aires, C1405CBA

  • Study site

    Buenos Aires, C1430BKO

  • Study site

    Córdoba, 5000

  • Study site

    La Plata, B1902CMK

  • Study site

    Salta, 4400

  • Study site

    Santa Fe, 03000

Other trials in Argentina

Greece9 sites

  • Study site

    Athens, 11522

  • Study site

    Athens, 13122

  • Study site

    Athens, 15123

  • Study site

    Haidari, 124.61

  • Study site

    Heraklion, 71110

  • Study site

    Neo Faliro, 18574

  • Study site

    Thessaloniki, 54639

  • Study site

    Thessaloniki, 56429

  • Study site

    Thessaloniki, 57001

Other trials in Greece

Hungary9 sites

  • Study site

    Budapest, 1122

  • Study site

    Budapest, 1125

  • Study site

    Budapest, 1529

  • Study site

    Deszk, 6772

  • Study site

    Kecskemét, 6000

  • Study site

    Mátraháza, 3233

  • Study site

    Nyíregyháza, 4400

  • Study site

    Pécs, 7635

  • Study site

    Törökbálint, 2045

Other trials in Hungary

Poland8 sites

  • Study site

    Gdansk, 80-214

  • Study site

    Lublin, 20-090

  • Study site

    Olsztyn, 10-228

  • Study site

    Poznan, 60-569

  • Study site

    Warsaw, 01-138

  • Study site

    Warsaw, 02-781

  • Study site

    Wroclaw, 53-439

  • Study site

    Zabrze, 41-843

Other trials in Poland

Sweden7 sites

  • Study site

    Falun, 79182

  • Study site

    Gothenburg, 41345

  • Study site

    Linköping, 58185

  • Study site

    Lund, 22185

  • Study site

    Malmö, 20502

  • Study site

    Stockholm, 17176

  • Study site

    Uppsala, 75185

Other trials in Sweden

Switzerland7 sites

  • Study site

    Aarau, 5000

  • Study site

    Aarau, 5001

  • Study site

    Baden, 5404

  • Study site

    Chur, 7000

  • Study site

    Locarno, 6601

  • Study site

    Lucerne, 6004

  • Study site

    Zurich, 8091

Other trials in Switzerland

Ireland6 sites

  • Study site

    Cork

  • Study site

    Dublin, 7

  • Study site

    Dublin, 8

  • Study site

    Dublin, 9

  • Study site

    Dublin

  • Study site

    Galway

Other trials in Ireland

Bulgaria5 sites

  • Study site

    Plovdiv, 4004

  • Study site

    Sofia, 1527

  • Study site

    Sofia, 1756

  • Study site

    Sofia, 1784

  • Study site

    Varna, 9010

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Czechia5 sites

  • Study site

    Brno, 639 00

  • Study site

    Hradec Králové, 500 05

  • Study site

    Olomouc, 775 20

  • Study site

    Pilsen, 305 99

  • Study site

    Prague, 180 00

Other trials in Czechia

India5 sites

  • Study site

    Bangalore, 560 076

  • Study site

    New Delhi, 110085

  • Study site

    New Delhi, 201 301

  • Study site

    Pune, 411 001

  • Study site

    Vellore, 632 004

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Portugal5 sites

  • Study site

    Lisbon, 1600

  • Study site

    Porto, 4200-072

  • Study site

    São Martinho do Bispo, 3041

  • Study site

    Setúbal, 2910-446

  • Study site

    Vila Nova de Gaia, 4400-129

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Slovakia5 sites

  • Study site

    Banská Bystrica, 975 17

  • Study site

    Bratislava, 825 56

  • Study site

    Košice, 041 90

  • Study site

    Nitra, 949 88

  • Study site

    Poprad, 058 87

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New Zealand4 sites

  • Study site

    Christchurch

  • Study site

    Hamilton, 3240

  • Study site

    Palmerston North

  • Study site

    Wellington, 6002

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Peru4 sites

  • Study site

    Callao

  • Study site

    Lima, 11

  • Study site

    Lima, 13

  • Study site

    Lima, 18

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Egypt3 sites

  • Study site

    Cairo, 11796

  • Study site

    Giza, 12568

  • Study site

    Giza

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Thailand3 sites

  • Study site

    Bangkok, 10110

  • Study site

    Bangkok, 10330

  • Study site

    Bangkok, 10700

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Bosnia and Herzegovina2 sites

  • Study site

    Banja Luka, 78000

  • Study site

    Sarajevo, 71000

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Colombia2 sites

  • Study site

    Bogotá

  • Study site

    Cali

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Ecuador2 sites

  • Study site

    Guayaquil

  • Study site

    Quito, 2569

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Estonia2 sites

  • Study site

    Tallinn, 11619

  • Study site

    Tartu, 50406

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Hong Kong2 sites

  • Study site

    Hong Kong, 852

  • Study site

    Hong Kong

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Latvia2 sites

  • Study site

    Riga, LV 1079

  • Study site

    Riga, LV-1002

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Lithuania2 sites

  • Study site

    Kaunas, 50009

  • Study site

    Vilnius, 08660

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Serbia2 sites

  • Study site

    Belgrade, 11000

  • Study site

    Novi Sad, 21000

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Venezuela2 sites

  • Study site

    Caracas, 1020

  • Study site

    Caracas, 1060

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Albania1 site

  • Study site

    Tirana, 1000

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Chile1 site

  • Study site

    Santiago

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Croatia1 site

  • Study site

    Zagreb, 10000

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Guatemala1 site

  • Study site

    Guatemala City, 01015

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Indonesia1 site

  • Study site

    Jakarta, 12940

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Malaysia1 site

  • Study site

    Kuala Lumpur, 59100

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Panama1 site

  • Study site

    Panama City, 0

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Saudi Arabia1 site

  • Study site

    Riyadh, 11426

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Slovenia1 site

  • Study site

    Ljubljana, 1000

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Uruguay1 site

  • Study site

    Montevideo, 11600

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About this study

Official title: An Expanded Access Program of Tarceva (Erlotinib) in Patients With Advanced Stage IIIB/IV Non-Small Cell Lung Cancer

This study will provide treatment with erlotinib to participants with advanced NSCLC who have received at least one course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study.

Being tested
Erlotinib
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.

  • ErlotinibDrug

    Also called Tarceva

    Erlotinib will be given orally as 150 milligrams (mg) once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason.

Study groups in NCT00949910
Study groupRoleWhat they receive
ErlotinibExperimentalErlotinib will be given as a single agent in this expanded access program (EAP) to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Treatment will continue until unacceptable toxicity, disease progression, or withdrawal for any other reason.
Receives: Drug: Erlotinib

What is being measured

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

  1. Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST)

    Objective response was defined as a best overall response of either complete response (CR) or partial response (PR) as assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. The percentage of participants (in nearest integer) with objective response was reported.

    Measured: Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter

Secondary outcomes (6)

  1. Percentage of Participants With Disease Control According to RECIST

    Disease control was defined as a best overall response of either CR, PR, or stable disease (SD) as assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. SD was defined as neither sufficient shrinkage to qualify for PR but less than (<) 20% increase in sum LD. The percentage of participants (in nearest integer) with disease control was reported.

    Measured: Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter

  2. Percentage of Participants by Best Overall Response According to RECIST

    Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. SD was defined as neither sufficient shrinkage to qualify for PR but <20% increase in sum LD. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants (in nearest integer unless the percentage is <1) with each type of best overall response was reported.

    Measured: Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter

  3. Percentage of Participants With Death or Disease Progression According to RECIST

    Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants (in nearest integer) who died or experienced PD was reported.

    Measured: Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter

  4. Progression-Free Survival (PFS) According to RECIST

    Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. The median duration of PFS and corresponding 95% confidence interval (CI) were estimated by Kaplan-Meier analysis and expressed in months.

    Measured: Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter

  5. Percentage of Participants Who Died

    The percentage of participants (in nearest integer) who died from any cause was reported.

    Measured: Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter

  6. Overall Survival (OS)

    OS was defined as the time from start of treatment to date of death for any reason. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.

    Measured: Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter

Timeline

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

  1. First posted31 Jul 2009 (estimated)
  2. Study startNov 2004
  3. Primary completionApr 2009
  4. Study completionApr 2009

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6,586 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00949910
Sponsor's protocol ID
MO18109
Other IDs
2004-000564-28, INC-9042, 2004
Status last verified
Oct 2016
First submitted
15 Apr 2009
Last updated
5 Oct 2016

Publications

  • Huang Y, Zhang L, Shi Y, Ma S, Liao M, Bai C, Zhang Q, Wang C, Luo F, Yu S, Qin S, Zhi X, Zhou C. Efficacy of erlotinib in previously treated patients with advanced non-small cell lung cancer: analysis of the Chinese subpopulation in the TRUST study. Jpn J Clin Oncol. 2015 Jun;45(6):569-75. doi: 10.1093/jjco/hyv036. Epub 2015 Apr 7.

    PubMed 25855621

  • Heigener DF, Wu YL, van Zandwijk N, Mali P, Horwood K, Reck M. Second-line erlotinib in patients with advanced non-small-cell lung cancer: subgroup analyses from the TRUST study. Lung Cancer. 2011 Nov;74(2):274-9. doi: 10.1016/j.lungcan.2011.02.017. Epub 2011 Mar 24.

    PubMed 21439671

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Erlotinib in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 543 sites in 51 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 3 inclusion and 3 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 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 543 sites in Italy, Germany, Brazil, Netherlands, Belgium and 46 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 4 Oct 2016). 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?

Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter). 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 NCT00949910, which also lists 2 linked publications.

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 5 Oct 2016.

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