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

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.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Erlotinib

• Study Type: Interventional
• Enrollment (Actual): 6586
• Phase: Phase 4

Contacts and Locations

Study Locations

• Albania
  • Tirana, Albania, 1000
• Argentina
  • Buenos Aires, Argentina, 1272
  • Buenos Aires, Argentina, 1437
  • Buenos Aires, Argentina, 1427
  • Buenos Aires, Argentina, C1405CBA
  • Buenos Aires, Argentina, C1430BKO
  • 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, 3002
  • Melbourne, Australia, 3084
  • 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, 1160
  • Wien, Austria, 1090
  • Wien, Austria, 1140
  • Wien, Austria, 1145
  • Zams, Austria, 6511
• Belgium
  • Aalst, Belgium, 9300
  • Antwerpen, Belgium, 2060
  • Antwerpen, Belgium, 2020
  • Antwerpen, Belgium, 2018
  • Arlon, Belgium, 6700
  • Baudour, Belgium, 7331
  • Blankenberge, Belgium, 8370
  • Borgerhout, Belgium, 2140
  • Boussu, Belgium, 7360
  • Brasschaat, Belgium, 2930
  • Bruxelles, Belgium, 1020
  • Bruxelles, Belgium, 1070
  • Bruxelles, Belgium, 1200
  • Bruxelles, Belgium, 1000
  • Bruxelles, Belgium, 1090
  • 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, 30140-083
  • Belo Horizonte, Brazil, 30150-221
  • Belo Horizonte, Brazil, 30150-320
  • Belo Horizonte, Brazil, 30180-061
  • Brasilia, Brazil, 70390-150
  • Brasilia, Brazil, 70710-904
  • Campinas, Brazil, 13073-400
  • Campinas, Brazil, 13084-759
  • 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
  • Jaú, Brazil, 17210-080
  • Joao Pessoa, Brazil, 58040280
  • Porto Alegre, Brazil, 90110-270
  • Porto Alegre, Brazil, 90610-000
  • Porto Alegre, Brazil, 90035-001
  • Porto Alegre, Brazil, 90480-003
  • Recife, Brazil, 52012-220
  • Ribeirao Preto, Brazil, 14025-430
  • Rio de Janeiro, Brazil, 22031072
  • Rio de Janeiro, Brazil, 22260-020
  • Rio de Janeiro, Brazil, 22359-900
  • Rio de Janeiro, Brazil, 22410-003
  • Salvador, Brazil, 41950-610
  • Salvador, Brazil, 40170-110
  • Salvador, Brazil, 41810-012
  • Santos, Brazil, 11075-350
  • Sao Paulo, Brazil, 01232-010
  • Sao Paulo, Brazil, 01308-000
  • Sao Paulo, Brazil, 01308-050
  • Sao Paulo, Brazil, 01332-000
  • Sao Paulo, Brazil, 01406100
  • Sao Paulo, Brazil, 01509-900
  • Sao Paulo, Brazil, 05651-901
  • Sao Paulo, Brazil, 04122-000
  • Sao Paulo, Brazil, 01509-010
  • Sao Paulo, Brazil, 04002-030
  • Sao Paulo, Brazil, 04521-022
  • Sao Paulo, Brazil, 05401-400
  • Sorocaba, Brazil, 18035-300
• Bulgaria
  • Plovdiv, Bulgaria, 4004
  • Sofia, Bulgaria, 1756
  • Sofia, Bulgaria, 1784
  • Sofia, Bulgaria, 1527
  • Varna, Bulgaria, 9010
• Chile
  • Santiago, Chile
• China
  • Beijing, China, 100730
  • Beijing, China, 100053
  • Beijing, China, 100021
  • Beijing, China, 101149
  • Chengdu, China, 610041
  • Guangzhou, China, 510060
  • Guangzhou, China, 510080
  • Hangzhou, China, 310022
  • Harbin, China, 150040
  • Nanjing, China, 210002
  • Shanghai, China, 200032
  • Shanghai, China, 200433
  • Shanghai, China, 200030
  • 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
  • Giza, Egypt, 12568
• Estonia
  • Tallin, Estonia, 11619
  • Tartu, Estonia, 50406
• Finland
  • Haemeenlinna, Finland, 13530
  • Helsinki, Finland, 00290
  • Helsinki, Finland, 00150
  • 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, 13353
  • Berlin, Germany, 13125
  • 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, 20246
  • Hamburg, Germany, 22767
  • 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, 81675
  • München, Germany, 81737
  • 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, 13122
  • Athens, Greece, 15123
  • Haidari, Greece, 124.61
  • Heraklion, Greece, 71110
  • Neo Faliro, Greece, 18574
  • Thessaloniki, Greece, 56429
  • Thessaloniki, Greece, 57001
  • Thessaloniki, Greece, 54639
• 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, 110085
  • New Delhi, India, 201 301
  • Pune, India, 411 001
  • Vellore, India, 632 004
• Indonesia
  • Jakarta, Indonesia, 12940
• Ireland
  • Cork, Ireland
  • Dublin, Ireland, 9
  • Dublin, Ireland
  • Dublin, Ireland, 7
  • Dublin, Ireland, 8
  • Galway, Ireland
• Israel
  • Ashkelon, Israel, 78306
  • Beer Sheva, Israel, 8410101
  • Haifa, Israel, 34354
  • Haifa, Israel, 35152
  • 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, 40138
  • Bologna, Italy, 40139
  • 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, 20162
  • Milano, Italy, 20157
  • Milano, Italy, 20133
  • Mirano, Italy, 30035
  • Modena, Italy, 41100
  • Napoli, Italy
  • Napoli, Italy, 80131
  • Nuoro, Italy, 081100
  • Orbassano, Italy, 10043
  • Palermo, Italy, 90127
  • Palermo, Italy, 90123
  • Parma, Italy, 43100
  • Pavia, Italy, 27100
  • Perugia, Italy, 06122
  • Pescara, Italy, 65124
  • Pisa, Italy, 56100
  • Rionero in Vulture, Italy, 85028
  • Roma, Italy, 00168
  • Roma, Italy, 00144
  • Roma, Italy, 00189
  • Roma, Italy, 00152
  • Roma, Italy, 00157
  • Roma, Italy, 00186
  • 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, 700-712
  • Daegu, Korea, Republic of, 700-721
  • 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, 614-735
  • Pusan, Korea, Republic of, 602-739
  • Pusan, Korea, Republic of, 602-702
  • Seoul, Korea, Republic of, 158-710
  • Seoul, Korea, Republic of, 138-736
  • Seoul, Korea, Republic of, 135-720
  • Seoul, Korea, Republic of, 133-792
  • Seoul, Korea, Republic of, 137-040
  • Seoul, Korea, Republic of, 136-705
  • Seoul, Korea, Republic of, 135-170
  • Seoul, Korea, Republic of, 405-760
  • Seoul, Korea, Republic of, 139-706
  • 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, 44340
  • Guadalajara, Mexico, 44220
  • Juarez, Mexico, 32310
  • Leon, Mexico, 37000
  • Leon, Mexico, 37160
  • Matamoros, Mexico, 87300
  • Merida, Mexico, 97070
  • Merida, Mexico, 97150
  • Mexicali, Mexico, 21100
  • Mexico City, Mexico, 03100
  • Mexico City, Mexico, 06700
  • Mexico City, Mexico, 07360
  • Mexico City, Mexico, 14080
  • Mexico City, Mexico, 14050
  • Mexico City, Mexico, 06720
  • Mexico City, Mexico, 11850
  • Mexico City, Mexico, 01120
  • Mexico City, Mexico, 72530
  • Mexico City, Mexico, 89400
  • Monterrey, Mexico, 64060
  • Monterrey, Mexico, 64320
  • Monterrey, Mexico, 64020
  • Monterrey, Mexico, 64380
  • Obregon, Mexico, 85100
  • Obregon, Mexico, 85000
  • 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
• Peru
  • Callao, Peru
  • Lima, Peru, 11
  • Lima, Peru, 13
  • Lima, Peru, 18
• Poland
  • Gdansk, Poland, 80-214
  • Lublin, Poland, 20-090
  • Olsztyn, Poland, 10-228
  • Poznan, Poland, 60-569
  • Warszawa, Poland, 01-138
  • Warszawa, Poland, 02-781
  • Wroclaw, Poland, 53-439
  • Zabrze, Poland, 41-843
• Portugal
  • Lisboa, Portugal, 1600
  • Porto, Portugal, 4200-072
  • Setubal, Portugal, 2910-446
  • São Martinho do Bispo, Portugal, 3041
  • Vila Nova de Gaia, Portugal, 4400-129
• Romania
  • Alba Iulia, Romania, 510073
  • Baia Mare, Romania
  • Bucharest, Romania
  • Bucharest, Romania, 022328
  • Bucharest, Romania, 010816
  • 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, 350040
  • Krasnodar, Russian Federation
  • 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, 5001
  • Aarau, Switzerland, 5000
  • Baden, Switzerland, 5404
  • Chur, Switzerland, 7000
  • Locarno, Switzerland, 6601
  • Luzern, Switzerland, 6004
  • Zürich, Switzerland, 8091
• Taiwan
  • Changhua, Taiwan, 500
  • Kaohsiung, Taiwan, 813
  • Kaohsiung, Taiwan, 00833
  • Kaohsiung, Taiwan, 807
  • Taichung, Taiwan, 404
  • Taichung, Taiwan, 407
  • Tainan, Taiwan, 704
  • Tainan, Taiwan, 710
  • Taipei, Taiwan, 114
  • Taipei, Taiwan, 104
  • Taipei, Taiwan, 112
  • Taipei, Taiwan, 00112
  • Taipei, Taiwan, 106
  • Taoyuan, Taiwan, 333
• Thailand
  • Bangkok, Thailand, 10700
  • Bangkok, Thailand, 10330
  • Bangkok, Thailand, 10110
• Turkey
  • Ankara, Turkey, 06100
  • Ankara, Turkey, 06500
  • Ankara, Turkey, 06018
  • Ankara, Turkey, 06590
  • Istanbul, Turkey
  • Istanbul, Turkey, 34300
  • Istanbul, Turkey, 34890
  • Izmir, Turkey, 35100
  • Izmir, Turkey, 35340
  • Shhiye, Ankara, Turkey, 06100
• Uruguay
  • Montevideo, Uruguay, 11600
• Venezuela
  • Caracas, Venezuela, 1060
  • Caracas, Venezuela, 1020

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erlotinib; Erlotinib 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.	Drug: Erlotinib; Erlotinib will be given orally as 150 milligrams (mg) once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason.; Other Names: Tarceva

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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
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.	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
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.	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
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.	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
Percentage of Participants Who Died	The percentage of participants (in nearest integer) who died from any cause was reported.	Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter
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.	Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: April 15, 2009
• First Submitted That Met QC Criteria: July 30, 2009
• First Posted (Estimate): July 31, 2009

Study Record Updates

• Last Update Posted (Estimate): October 5, 2016
• Last Update Submitted That Met QC Criteria: October 4, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Erlotinib Hydrochloride
• Other Study ID Numbers: MO18109; 2004-000564-28 (EudraCT Number); INC-9042 (Other Identifier: INC Research Netherlands BV)