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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00949910
First received: April 15, 2009
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

This study will provide treatment with Tarceva to patients with advanced NSCLC who have received >=1 course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study. The anticipated time on study treatment is as long as the patient is, in the investigator's opinion, benefiting from the therapy and the target sample size is 500+ individuals.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: erlotinib [Tarceva]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Expanded-access Study of the Effect of Tarceva on Treatment Response in Patients With Advanced Stage IIIB/IV Non-small-cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety:Adverse events, serious adverse events, premature withdrawals\n\n [ Time Frame: At each clinic visit, throughout study.Length of study not specified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: Response rate, time to progression, survival [ Time Frame: At each clinic visit, throughout study. length of study not specified ] [ Designated as safety issue: No ]

Enrollment: 7040
Study Start Date: November 2004
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: erlotinib [Tarceva]
1

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients >=18 years of age;
  • histologically or cytologically documented inoperable, locally advanced, metastatic, or recurrent NSCLC;
  • previous treatment with <=2 prior chemotherapy regimens.

Exclusion Criteria:

  • previous systemic anti-cancer therapy with HER1/EGFR inhibitors;
  • inability to take oral medication;
  • any other malignancies within 5 years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949910

  Hide Study Locations
Locations
Albania
Tirana, Albania, 1000
Argentina
Buenos Aires, Argentina, C1430BKO
Buenos Aires, Argentina, C1405CBA
Buenos Aires, Argentina, 1272
Buenos Aires, Argentina, 1427
Buenos Aires, Argentina, 1437
Córdoba, Argentina, 5000
La Plata, Argentina, B1902CMK
Salta, Argentina, 4400
Santa Fe, Argentina, 03000
Australia
Adelaide, Australia, 5011
Camperdown, Australia, 2050
Chermside, Australia, 4032
Frankston, Australia, 3199
Fremantle, Australia, 6160
Geelong, Australia, 3220
Kurralta Park, Australia, 5037
Malvern, Australia, 3144
Melbourne, Australia, 3084
Melbourne, Australia, 3002
Perth, Australia, 6009
St. Leonards, Australia, 2065
Sydney, Australia, 2031
Sydney, Australia, 2217
Tugun, Australia, 4224
Waratah, Australia, 2298
Wodonga, Australia, 3690
Wollongong, Australia, 2500
Austria
Bludesch, Austria, 6712
Grimmenstein, Austria, 2840
Innsbruck, Austria, 6020
Klagenfurt, Austria, 9010
Kufstein, Austria, 6330
Leoben, Austria, 8700
Linz, Austria, 4020
Linz, Austria, 4010
Natters, Austria, 6161
Oberpullendorf, Austria, 7350
Salzburg, Austria, 5020
Wels, Austria, 4600
Wien, Austria, 1130
Wien, Austria, 1090
Wien, Austria, 1145
Wien, Austria, 1160
Wien, Austria, 1140
Zams, Austria, 6511
Belgium
Aalst, Belgium, 9300
Antwerpen, Belgium, 2020
Antwerpen, Belgium, 2018
Antwerpen, Belgium, 2060
Arlon, Belgium, 6700
Baudour, Belgium, 7331
Blankenberge, Belgium, 8370
Borgerhout, Belgium, 2140
Boussu, Belgium, 7360
Brasschaat, Belgium, 2930
Bruxelles, Belgium, 1070
Bruxelles, Belgium, 1090
Bruxelles, Belgium, 1000
Bruxelles, Belgium, 1020
Bruxelles, Belgium, 1200
Charleroi, Belgium, 6000
Edegem, Belgium, 2650
Genk, Belgium, 3600
Gent, Belgium, 9000
Gilly, Belgium, 6060
Godinne, Belgium, 5530
Gosselies, Belgium, 6041
Haine-saint-paul, Belgium, 7100
Hasselt, Belgium, 3500
Kortrijk, Belgium, 8500
Libramont, Belgium, 6800
Liege, Belgium, 4000
Mons, Belgium, 7000
Namur, Belgium, 5000
Oostende, Belgium, 8400
Ottignies, Belgium, 1340
Oudenaarde, Belgium, 9700
Roeselare, Belgium, 8800
Sint-niklaas, Belgium, 9100
Tielt, Belgium, 8700
Tournai, Belgium, 7500
Turnhout, Belgium, 2300
Wilrijk, Belgium, 2610
Bosnia and Herzegovina
Banja Luka, Bosnia and Herzegovina, 78000
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
Belo Horizonte, Brazil, 30180-061
Belo Horizonte, Brazil, 30140-083
Belo Horizonte, Brazil, 30150-221
Belo Horizonte, Brazil, 30150-320
Brasilia, Brazil, 70390-150
Brasilia, Brazil, 70710-904
Campinas, Brazil, 13084-759
Campinas, Brazil, 13073-400
Caxias Do Sul, Brazil, 95020-450
Curitiba, Brazil, 80530-010
Curitiba, Brazil, 80730-180
Curitiba, Brazil, 80440-080
Fortaleza, Brazil, 60125-151
Fortaleza, Brazil, 60741-420
Fortaleza, Brazil, 60336-550
Ijui, Brazil, 98700-000
JAU, Brazil, 17210-080
Joao Pessoa, Brazil, 58040280
Porto Alegre, Brazil, 90110-270
Porto Alegre, Brazil, 90610-000
Porto Alegre, Brazil, 90480-003
Porto Alegre, Brazil, 90035-001
Recife, Brazil, 52012-220
Ribeirao Preto, Brazil, 14025-430
Rio de Janeiro, Brazil, 22410-003
Rio de Janeiro, Brazil, 22260-020
Rio de Janeiro, Brazil, 22359-900
Rio de Janeiro, Brazil, 22031072
Salvador, Brazil, 41950-610
Salvador, Brazil, 41810-012
Salvador, Brazil, 40170-110
Santos, Brazil, 11075-350
Sao Paulo, Brazil, 04002-030
Sao Paulo, Brazil, 05401-400
Sao Paulo, Brazil, 01509-010
Sao Paulo, Brazil, 01232-010
Sao Paulo, Brazil, 05651-901
Sao Paulo, Brazil, 01406100
Sao Paulo, Brazil, 01332-000
Sao Paulo, Brazil, 01308-050
Sao Paulo, Brazil, 04521-022
Sao Paulo, Brazil, 01308-000
Sao Paulo, Brazil, 01509-900
Sao Paulo, Brazil, 04122-000
Sorocaba, Brazil, 18035-300
Bulgaria
Plovdiv, Bulgaria, 4004
Sofia, Bulgaria, 1527
Sofia, Bulgaria, 1784
Sofia, Bulgaria, 1756
Varna, Bulgaria, 9010
Chile
Santiago, Chile
China
Beijing, China, 100021
Beijing, China, 101149
Beijing, China, 100053
Beijing, China, 100730
Chengdu, China, 610041
Guangzhou, China, 510080
Guangzhou, China, 510060
Hangzhou, China, 310022
Harbin, China, 150040
Nanjing, China, 210002
Shanghai, China, 200032
Shanghai, China, 200030
Shanghai, China, 200433
Tianjin, China, 300060
Wuhan, China, 430030
Colombia
Bogota, Colombia
Cali, Colombia
Croatia
Zagreb, Croatia, 10000
Czech Republic
Brno, Czech Republic, 639 00
Hradec Kralove, Czech Republic, 500 05
Olomouc, Czech Republic, 775 20
Plzen, Czech Republic, 305 99
Praha, Czech Republic, 180 00
Ecuador
Guayaquil, Ecuador
Quito, Ecuador, 2569
Egypt
Cairo, Egypt, 11796
Giza, Egypt, 12568
Giza, Egypt
Estonia
Tallin, Estonia, 11619
Tartu, Estonia, 50406
Finland
Haemeenlinna, Finland, 13530
Helsinki, Finland, 00150
Helsinki, Finland, 00290
Joensuu, Finland, 80210
Kuopio, Finland, 70211
Oulu, Finland, 90029
Pori, Finland, 28500
Tampere, Finland, 33520
Turku, Finland, 20520
Vaasa, Finland, 65130
Germany
Amberg, Germany, 92224
Augsburg, Germany, 86150
Aurich, Germany, 26603
Bad Berka, Germany, 99437
Berlin, Germany, 13125
Berlin, Germany, 13353
Berlin, Germany, 12203
Bonn, Germany, 53113
Celle, Germany, 29221
Dortmund, Germany, 44137
Dresden, Germany, 01219
Essen, Germany, 45122
Flensburg, Germany, 24939
Frankfurt, Germany, 60488
Frankfurt Am Main, Germany, 65929
Freiburg, Germany, 79106
Gauting, Germany, 82131
Gerlingen, Germany, 70839
Giessen, Germany, 35392
Grosshansdorf, Germany, 22927
Halle (saale), Germany, 06120
Hamburg, Germany, 22767
Hamburg, Germany, 20246
Heidelberg, Germany, 69126
Herne, Germany, 44625
Homburg/saar, Germany, 66424
Kassel, Germany, 34125
Koblenz, Germany, 56073
Köln, Germany, 50677
Köln, Germany, 51109
Leipzig, Germany, 04207
Leverkusen, Germany, 51375
Lostau, Germany, 39291
Löwenstein, Germany, 74245
Lübeck, Germany, 23562
Mainz, Germany, 55101
Mannheim, Germany, 68167
Minden, Germany, 32429
Muenchen, Germany, 80336
Mönchengladbach, Germany, 41063
München, Germany, 81737
München, Germany, 81675
Neuruppin, Germany, 16816
Nürnberg, Germany, 90419
Oldenburg, Germany, 26121
Osnabrück, Germany, 49076
Rostock, Germany, 18055
Saarbruecken, Germany, 66113
Trier, Germany, 54290
ULM, Germany, 89081
Wangen, Germany, 88239
Wiesbaden, Germany, 65199
Wuerselen, Germany, 52146
Wuppertal, Germany, 42283
Greece
Athens, Greece, 11522
Athens, Greece, 15123
Athens, Greece, 13122
Haidari, Greece, 124.61
Heraklion, Greece, 71110
Neo Faliro, Greece, 18574
Thessaloniki, Greece, 54639
Thessaloniki, Greece, 56429
Thessaloniki, Greece, 57001
Guatemala
Guatemala City, Guatemala, 01015
Hong Kong
Hong Kong, Hong Kong
Hong Kong, Hong Kong, 852
Hungary
Budapest, Hungary, 1125
Budapest, Hungary, 1122
Budapest, Hungary, 1529
Deszk, Hungary, 6772
Kecskemet, Hungary, 6000
Mátraháza, Hungary, 3233
Nyíregyháza, Hungary, 4400
Pecs, Hungary, 7635
Torokbalint, Hungary, 2045
India
Bangalore, India, 560 076
New Delhi, India, 201 301
New Delhi, India, 110085
Pune, India, 411 001
Vellore, India, 632 004
Indonesia
Jakarta, Indonesia, 12940
Ireland
Cork, Ireland
Dublin, Ireland, 7
Dublin, Ireland, 8
Dublin, Ireland, 9
Dublin, Ireland
Galway, Ireland
Israel
Ashkelon, Israel, 78306
Beer Sheva, Israel, 8410101
Haifa, Israel, 35152
Haifa, Israel, 34354
Holon, Israel, 58100
Jerusalem, Israel, 91120
Jerusalem, Israel, 91031
Kfar Saba, Israel, 44281
Nahariya, Israel, 22100
Petach Tikva, Israel, 49100
Ramat-gan, Israel, 52621
Rehovot, Israel, 76100
Safed, Israel, 13110
Tel Aviv, Israel, 6423906
Zerifin, Israel, 70300
Italy
Ancona, Italy, 60121
Avellino, Italy, 83100
Aviano, Italy, 33081
Bari, Italy, 70124
Benevento, Italy, 82100
Bergamo, Italy, 24128
Bollate, Italy, 20021
Bologna, Italy, 40139
Bologna, Italy, 40138
Brescia, Italy, 25123
Candiolo, Italy, 10060
Catania, Italy, 95100
Catanzaro, Italy, 88100
Cosenza, Italy, 87100
Cuneo, Italy, 12100
Fabriano, Italy, 60044
Feltre - Bl, Italy, 32032
Firenze, Italy, 50139
Genova, Italy, 16132
La Spezia, Italy, 19100
Lido Di Camaiore, Italy, 55043
Livorno, Italy, 57100
Meldola, Italy, 47014
Messina, Italy, 98123
Milano, Italy, 20133
Milano, Italy, 20157
Milano, Italy, 20162
Mirano, Italy, 30035
Modena, Italy, 41100
Napoli, Italy
Napoli, Italy, 80131
Nuoro, Italy, 081100
Orbassano, Italy, 10043
Palermo, Italy, 90123
Palermo, Italy, 90127
Parma, Italy, 43100
Pavia, Italy, 27100
Perugia, Italy, 06122
Pescara, Italy, 65124
Pisa, Italy, 56100
Rionero in Vulture, Italy, 85028
Roma, Italy, 00144
Roma, Italy, 00168
Roma, Italy, 00186
Roma, Italy, 00189
Roma, Italy, 00152
Roma, Italy, 00157
Salerno, Italy, 84131
Salerno, Italy, 80124
San Giovanni Rotondo, Italy, 71013
Sassari, Italy, 07100
Siena, Italy, 53100
Sondrio, Italy, 23100
Taormina, Italy, 98030
Torino, Italy, 10126
Trento, Italy, 38100
Udine, Italy, 33100
Korea, Republic of
Bundang City, Korea, Republic of, 463-802
Busan, Korea, Republic of, 602-715
Cheonan, Korea, Republic of, 330-715
Daegu, Korea, Republic of, 705-717
Daegu, Korea, Republic of, 700-721
Daegu, Korea, Republic of, 700-712
Daejeon, Korea, Republic of, 301-721
Gwangju, Korea, Republic of, 501-757
Iksan, Korea, Republic of, 570-711
Incheon, Korea, Republic of, 400-711
Kyunggi-do, Korea, Republic of, 411-769
Pusan, Korea, Republic of, 602-739
Pusan, Korea, Republic of, 614-735
Pusan, Korea, Republic of, 602-702
Seoul, Korea, Republic of, 136-705
Seoul, Korea, Republic of, 405-760
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 135-720
Seoul, Korea, Republic of, 158-710
Seoul, Korea, Republic of, 139-706
Seoul, Korea, Republic of, 137-040
Seoul, Korea, Republic of, 133-792
Seoul, Korea, Republic of, 135-170
Suwon, Korea, Republic of, 442-721
Latvia
Riga, Latvia, LV-1002
Riga, Latvia, LV 1079
Lithuania
Kaunas, Lithuania, 50009
Vilnius, Lithuania, 08660
Malaysia
Kuala Lumpur, Malaysia, 59100
Mexico
Acapulco, Mexico, 39850
Chihuahua, Mexico, 31238
Chihuahua, Mexico, 31000
Guadalajara, Mexico, 44220
Guadalajara, Mexico, 44340
Juarez, Mexico, 32310
Leon, Mexico, 37000
Leon, Mexico, 37160
Matamoros, Mexico, 87300
Merida, Mexico, 97070
Merida, Mexico, 97150
Mexicali, Mexico, 21100
Mexico City, Mexico, 06720
Mexico City, Mexico, 11850
Mexico City, Mexico, 14050
Mexico City, Mexico, 03100
Mexico City, Mexico, 07360
Mexico City, Mexico, 01120
Mexico City, Mexico, 72530
Mexico City, Mexico, 14080
Mexico City, Mexico, 06700
Mexico City, Mexico, 89400
Monterrey, Mexico, 64320
Monterrey, Mexico, 64380
Monterrey, Mexico, 64020
Monterrey, Mexico, 64060
Obregon, Mexico, 85000
Obregon, Mexico, 85100
Puebla, Mexico, 72530
San Luis Potosi, Mexico, 78230
Tampico, Mexico, 89120
Tijuana, Mexico, 22320
Toluca, Mexico, 52140
Torreon, Mexico, 27200
Zapopan, Mexico, 44349
Netherlands
's Hertogenbosch, Netherlands, 5211 RW
Alkmaar, Netherlands, 1815 JD
Amersfoort, Netherlands, 3818 ES
Amstelveen, Netherlands, 1186 AH
Amsterdam, Netherlands, 1105 AZ
Amsterdam, Netherlands, 1091 AC
Amsterdam, Netherlands, 1066 CX
Amsterdam, Netherlands, 1007 MB
Amsterdam, Netherlands, 1061 AE
Arnhem, Netherlands, 6815 AD
Assen, Netherlands, 9401 RK
Beverwijk, Netherlands, 1942 LE
Boxmeer, Netherlands, 5831 HA
Breda, Netherlands, 4819 EV
Capelle Ad Yssel, Netherlands, 2906 ZC
Den Haag, Netherlands, 2504 LN
Drachten, Netherlands, 9202 NN
Eindhoven, Netherlands, 5623 EJ
Enschede, Netherlands, 7513 ER
Groningen, Netherlands, 9713 GZ
Groningen, Netherlands, 9728 NZ
Haarlem, Netherlands, 2035 RC
Harderwijk, Netherlands, 3844 DG
Heerlen, Netherlands, 6419 PC
Helmond, Netherlands, 5700 AB
Hengelo, Netherlands, 7555 DL
Hoofddorp, Netherlands, 2134 TM
Leiden, Netherlands, 2333 ZA
Leiderdorp, Netherlands, 2353 GA
Maastricht, Netherlands, 6229 HX
Nieuwegein, Netherlands, 3435 CM
Nijmegen, Netherlands, 6532 SZ
Roermond, Netherlands, 6043 CV
Rotterdam, Netherlands, 3045 PM
Sliedrecht, Netherlands, 3361 XV
Veldhoven, Netherlands, 5504 DB
Venlo, Netherlands, 5912 BL
Vlaardingen, Netherlands, 3136 LA
Vlissingen, Netherlands, 4382 EE
Zaandam, Netherlands, 1502 DV
Zwolle, Netherlands, 8011 JW
New Zealand
Christchurch, New Zealand
Hamilton, New Zealand, 3240
Palmerston North, New Zealand
Wellington, New Zealand, 6002
Panama
Panama City, Panama, 0
Peru
Callao, Peru
Lima, Peru, 11
Lima, Peru, 18
Lima, Peru, 13
Poland
Gdansk, Poland, 80-214
Lublin, Poland, 20-090
Olsztyn, Poland, 10-228
Poznan, Poland, 60-569
Warszawa, Poland, 02-781
Warszawa, Poland, 01-138
Wroclaw, Poland, 53-439
Zabrze, Poland, 41-843
Portugal
Lisboa, Portugal, 1600
Porto, Portugal, 4200-072
S Martinho Do Bispo, Portugal, 3041
Setubal, Portugal, 2910-446
Vila Nova de Gaia, Portugal, 4400-129
Romania
Alba Iulia, Romania, 510073
Baia Mare, Romania
Bucharest, Romania
Bucharest, Romania, 010816
Bucharest, Romania, 022328
Cluj Napoca, Romania, 400015
Oradea, Romania
Sibiu, Romania
Suceava, Romania
Timisoara, Romania, 1900
Russian Federation
Barnaul, Russian Federation, 656049
Kazan, Russian Federation, 420029
Kazan, Russian Federation, 420111
Krasnodar, Russian Federation
Krasnodar, Russian Federation, 350040
Moscow, Russian Federation, 107005
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 143423
Obninsk, Russian Federation, 249036
Samara, Russian Federation, 443031
Smolensk, Russian Federation, 214000
St Petersburg, Russian Federation, 197022
St Petersburg, Russian Federation, 197758
Stavropol, Russian Federation, 355047
Tumen, Russian Federation, 625047
UFA, Russian Federation, 450054
Volgograd, Russian Federation, 400138
Saudi Arabia
Riyadh, Saudi Arabia, 11426
Serbia
Belgrade, Serbia, 11000
Novi Sad, Serbia, 21000
Slovakia
Banska Bystrica, Slovakia, 975 17
Bratislava, Slovakia, 825 56
Kosice, Slovakia, 041 90
Nitra, Slovakia, 949 88
Poprad, Slovakia, 058 87
Slovenia
Ljubljana, Slovenia, 1000
Sweden
Falun, Sweden, 79182
Goeteborg, Sweden, 41345
Göteborg, Sweden, 41345
Linkoeping, Sweden, 58185
Lund, Sweden, 22185
Malmoe, Sweden, 20502
Stockholm, Sweden, 17176
Uppsala, Sweden, 75185
Switzerland
Aarau, Switzerland, 5000
Aarau, Switzerland, 5001
Baden, Switzerland, 5404
Chur, Switzerland, 7000
Locarno, Switzerland, 6601
Luzern, Switzerland, 6004
Zürich, Switzerland, 8091
Taiwan
Changhua, Taiwan, 500
Kaohsiung, Taiwan, 807
Kaohsiung, Taiwan, 813
Kaohsiung, Taiwan, 00833
Taichung, Taiwan, 404
Taichung, Taiwan, 407
Tainan, Taiwan, 704
Tainan, Taiwan, 710
Taipei, Taiwan, 00112
Taipei, Taiwan, 104
Taipei, Taiwan, 112
Taipei, Taiwan, 114
Taipei, Taiwan, 106
Taoyuan, Taiwan, 333
Thailand
Bangkok, Thailand, 10330
Bangkok, Thailand, 10700
Bangkok, Thailand, 10110
Turkey
Ankara, Turkey, 06590
Ankara, Turkey, 06500
Ankara, Turkey, 06100
Ankara, Turkey, 06018
Istanbul, Turkey, 34300
Istanbul, Turkey
Istanbul, Turkey, 34890
Izmir, Turkey, 35340
Izmir, Turkey, 35100
Shhiye, Ankara, Turkey, 06100
Uruguay
Montevideo, Uruguay, 11600
Venezuela
Caracas, Venezuela, 1020
Caracas, Venezuela, 1060
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00949910     History of Changes
Other Study ID Numbers: MO18109
Study First Received: April 15, 2009
Last Updated: May 5, 2014
Health Authority: Netherlands:Medicines Evaluation Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Erlotinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014