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

NCT ID: NCT00949910

Last Updated: 2016-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 6586 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2009-04-30

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Erlotinib

Intervention Type: DRUG

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

Interventions

Erlotinib

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

Intervention Type: DRUG

Other Intervention Names

Tarceva

Eligibility Criteria

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

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

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

Tirana, , Albania

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Córdoba, , Argentina

La Plata, , Argentina

Salta, , Argentina

Santa Fe, , Argentina

Adelaide, , Australia

Camperdown, , Australia

Chermside, , Australia

Frankston, , Australia

Fremantle, , Australia

Geelong, , Australia

Kurralta Park, , Australia

Malvern, , Australia

Melbourne, , Australia

Melbourne, , Australia

Perth, , Australia

St Leonards, , Australia

Sydney, , Australia

Sydney, , Australia

Tugun, , Australia

Waratah, , Australia

Wodonga, , Australia

Wollongong, , Australia

Bludesch, , Austria

Grimmenstein, , Austria

Innsbruck, , Austria

Klagenfurt, , Austria

Kufstein, , Austria

Leoben, , Austria

Linz, , Austria

Linz, , Austria

Natters, , Austria

Oberpullendorf, , Austria

Salzburg, , Austria

Vienna, , Austria

Vienna, , Austria

Vienna, , Austria

Vienna, , Austria

Vienna, , Austria

Wels, , Austria

Zams, , Austria

Aalst, , Belgium

Antwerp, , Belgium

Antwerp, , Belgium

Antwerp, , Belgium

Arlon, , Belgium

Baudour, , Belgium

Blankenberge, , Belgium

Borgerhout, , Belgium

Boussu, , Belgium

Brasschaat, , Belgium

Brussels, , Belgium

Brussels, , Belgium

Brussels, , Belgium

Brussels, , Belgium

Brussels, , Belgium

Charleroi, , Belgium

Edegem, , Belgium

Genk, , Belgium

Ghent, , Belgium

Gilly, , Belgium

Godinne, , Belgium

Gosselies, , Belgium

Haine-Saint-Paul, , Belgium

Hasselt, , Belgium

Kortrijk, , Belgium

Libramont, , Belgium

Liège, , Belgium

Mons, , Belgium

Namur, , Belgium

Ostend, , Belgium

Ottignies, , Belgium

Oudenaarde, , Belgium

Roeselare, , Belgium

Sint-Niklaas, , Belgium

Tielt, , Belgium

Tournai, , Belgium

Turnhout, , Belgium

Wilrijk, , Belgium

Banja Luka, , Bosnia and Herzegovina

Sarajevo, , Bosnia and Herzegovina

Belo Horizonte, , Brazil

Belo Horizonte, , Brazil

Belo Horizonte, , Brazil

Belo Horizonte, , Brazil

Brasília, , Brazil

Brasília, , Brazil

Campinas, , Brazil

Campinas, , Brazil

Caxias do Sul, , Brazil

Curitiba, , Brazil

Curitiba, , Brazil

Curitiba, , Brazil

Fortaleza, , Brazil

Fortaleza, , Brazil

Fortaleza, , Brazil

Ijuí, , Brazil

Jaú, , Brazil

João Pessoa, , Brazil

Porto Alegre, , Brazil

Porto Alegre, , Brazil

Porto Alegre, , Brazil

Porto Alegre, , Brazil

Recife, , Brazil

Ribeirão Preto, , Brazil

Rio de Janeiro, , Brazil

Rio de Janeiro, , Brazil

Rio de Janeiro, , Brazil

Rio de Janeiro, , Brazil

Salvador, , Brazil

Salvador, , Brazil

Salvador, , Brazil

Santos, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

Sorocaba, , Brazil

Plovdiv, , Bulgaria

Sofia, , Bulgaria

Sofia, , Bulgaria

Sofia, , Bulgaria

Varna, , Bulgaria

Santiago, , Chile

Beijing, , China

Beijing, , China

Beijing, , China

Beijing, , China

Chengdu, , China

Guangzhou, , China

Guangzhou, , China

Hangzhou, , China

Harbin, , China

Nanjing, , China

Shanghai, , China

Shanghai, , China

Shanghai, , China

Tianjin, , China

Wuhan, , China

Bogotá, , Colombia

Cali, , Colombia

Zagreb, , Croatia

Brno, , Czechia

Hradec Králové, , Czechia

Olomouc, , Czechia

Pilsen, , Czechia

Prague, , Czechia

Guayaquil, , Ecuador

Quito, , Ecuador

Cairo, , Egypt

Giza, , Egypt

Giza, , Egypt

Tallinn, , Estonia

Tartu, , Estonia

Hämeenlinna, , Finland

Helsinki, , Finland

Helsinki, , Finland

Joensuu, , Finland

Kuopio, , Finland

Oulu, , Finland

Pori, , Finland

Tampere, , Finland

Turku, , Finland

Vaasa, , Finland

Amberg, , Germany

Augsburg, , Germany

Aurich, , Germany

Bad Berka, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Bonn, , Germany

Celle, , Germany

Cologne, , Germany

Cologne, , Germany

Dortmund, , Germany

Dresden, , Germany

Essen, , Germany

Flensburg, , Germany

Frankfurt, , Germany

Frankfurt am Main, , Germany

Freiburg im Breisgau, , Germany

Gauting, , Germany

Gerlingen, , Germany

Giessen, , Germany

Großhansdorf, , Germany

Halle, , Germany

Hamburg, , Germany

Hamburg, , Germany

Heidelberg, , Germany

Herne, , Germany

Homburg/Saar, , Germany

Kassel, , Germany

Koblenz, , Germany

Leipzig, , Germany

Leverkusen, , Germany

Lostau, , Germany

Löwenstein, , Germany

Lübeck, , Germany

Mainz, , Germany

Mannheim, , Germany

Minden, , Germany

Mönchengladbach, , Germany

München, , Germany

München, , Germany

München, , Germany

Neuruppin, , Germany

Nuremberg, , Germany

Oldenburg, , Germany

Osnabrück, , Germany

Rostock, , Germany

Saarbrücken, , Germany

Trier, , Germany

Ulm, , Germany

Wangen, , Germany

Wiesbaden, , Germany

Wuppertal, , Germany

Würselen, , Germany

Athens, , Greece

Athens, , Greece

Athens, , Greece

Haidari, , Greece

Heraklion, , Greece

Neo Faliro, , Greece

Thessaloniki, , Greece

Thessaloniki, , Greece

Thessaloniki, , Greece

Guatemala City, , Guatemala

Hong Kong, , Hong Kong

Hong Kong, , Hong Kong

Budapest, , Hungary

Budapest, , Hungary

Budapest, , Hungary

Deszk, , Hungary

Kecskemét, , Hungary

Mátraháza, , Hungary

Nyíregyháza, , Hungary

Pécs, , Hungary

Törökbálint, , Hungary

Bangalore, , India

New Delhi, , India

New Delhi, , India

Pune, , India

Vellore, , India

Jakarta, , Indonesia

Cork, , Ireland

Dublin, , Ireland

Dublin, , Ireland

Dublin, , Ireland

Dublin, , Ireland

Galway, , Ireland

Ashkelon, , Israel

Beersheba, , Israel

Haifa, , Israel

Haifa, , Israel

Holon, , Israel

Jerusalem, , Israel

Jerusalem, , Israel

Kfar Saba, , Israel

Nahariya, , Israel

Petah Tikva, , Israel

Ramat Gan, , Israel

Rehovot, , Israel

Safed, , Israel

Tel Aviv, , Israel

Ẕerifin, , Israel

Ancona, , Italy

Avellino, , Italy

Aviano, , Italy

Bari, , Italy

Benevento, , Italy

Bergamo, , Italy

Bollate, , Italy

Bologna, , Italy

Bologna, , Italy

Brescia, , Italy

Candiolo, , Italy

Catania, , Italy

Catanzaro, , Italy

Cosenza, , Italy

Cuneo, , Italy

Fabriano, , Italy

Feltre - Bl, , Italy

Florence, , Italy

Genova, , Italy

La Spezia, , Italy

Lido di Camaiore, , Italy

Livorno, , Italy

Meldola, , Italy

Messina, , Italy

Milan, , Italy

Milan, , Italy

Milan, , Italy

Mirano, , Italy

Modena, , Italy

Napoli, , Italy

Napoli, , Italy

Nuoro, , Italy

Orbassano, , Italy

Palermo, , Italy

Palermo, , Italy

Parma, , Italy

Pavia, , Italy

Perugia, , Italy

Pescara, , Italy

Pisa, , Italy

Rionero in Vulture, , Italy

Roma, , Italy

Roma, , Italy

Roma, , Italy

Roma, , Italy

Roma, , Italy

Roma, , Italy

Salerno, , Italy

Salerno, , Italy

San Giovanni Rotondo, , Italy

Sassari, , Italy

Siena, , Italy

Sondrio, , Italy

Taormina, , Italy

Torino, , Italy

Trento, , Italy

Udine, , Italy

Riga, , Latvia

Riga, , Latvia

Kaunas, , Lithuania

Vilnius, , Lithuania

Kuala Lumpur, , Malaysia

Acapulco, , Mexico

Chihuahua City, , Mexico

Chihuahua City, , Mexico

Guadalajara, , Mexico

Guadalajara, , Mexico

Juárez, , Mexico

León, , Mexico

León, , Mexico

Matamoros, , Mexico

Mexicali, , Mexico

Mexico City, , Mexico

Mexico City, , Mexico

Mexico City, , Mexico

Mexico City, , Mexico

Mexico City, , Mexico

Mexico City, , Mexico

Mexico City, , Mexico

Mexico City, , Mexico

Mexico City, , Mexico

Mexico City, , Mexico

Mérida, , Mexico

Mérida, , Mexico

Monterrey, , Mexico

Monterrey, , Mexico

Monterrey, , Mexico

Monterrey, , Mexico

Obregón, , Mexico

Obregón, , Mexico

Puebla City, , Mexico

San Luis Potosí City, , Mexico

Tampico, , Mexico

Tijuana, , Mexico

Toluca, , Mexico

Torreón, , Mexico

Zapopan, , Mexico

's-Hertogenbosch, , Netherlands

Alkmaar, , Netherlands

Amersfoort, , Netherlands

Amstelveen, , Netherlands

Amsterdam, , Netherlands

Amsterdam, , Netherlands

Amsterdam, , Netherlands

Amsterdam, , Netherlands

Amsterdam, , Netherlands

Arnhem, , Netherlands

Assen, , Netherlands

Beverwijk, , Netherlands

Boxmeer, , Netherlands

Breda, , Netherlands

Capelle Ad Yssel, , Netherlands

Drachten, , Netherlands

Eindhoven, , Netherlands

Enschede, , Netherlands

Flushing, , Netherlands

Groningen, , Netherlands

Groningen, , Netherlands

Haarlem, , Netherlands

Harderwijk, , Netherlands

Heerlen, , Netherlands

Helmond, , Netherlands

Hengelo, , Netherlands

Hoofddorp, , Netherlands

Leiden, , Netherlands

Leiderdorp, , Netherlands

Maastricht, , Netherlands

Nieuwegein, , Netherlands

Nijmegen, , Netherlands

Roermond, , Netherlands

Rotterdam, , Netherlands

Sliedrecht, , Netherlands

The Hague, , Netherlands

Veldhoven, , Netherlands

Venlo, , Netherlands

Vlaardingen, , Netherlands

Zaandam, , Netherlands

Zwolle, , Netherlands

Christchurch, , New Zealand

Hamilton, , New Zealand

Palmerston North, , New Zealand

Wellington, , New Zealand

Panama City, , Panama

Callao, , Peru

Lima, , Peru

Lima, , Peru

Lima, , Peru

Gdansk, , Poland

Lublin, , Poland

Olsztyn, , Poland

Poznan, , Poland

Warsaw, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Zabrze, , Poland

Lisbon, , Portugal

Porto, , Portugal

São Martinho do Bispo, , Portugal

Setúbal, , Portugal

Vila Nova de Gaia, , Portugal

Alba Iulia, , Romania

Baia Mare, , Romania

Bucharest, , Romania

Bucharest, , Romania

Bucharest, , Romania

Cluj-Napoca, , Romania

Oradea, , Romania

Sibiu, , Romania

Suceava, , Romania

Timișoara, , Romania

Barnaul, , Russia

Kazan', , Russia

Kazan', , Russia

Krasnodar, , Russia

Krasnodar, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Obninsk, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Samara, , Russia

Smolensk, , Russia

Stavropol, , Russia

Tyumen, , Russia

Ufa, , Russia

Volgograd, , Russia

Riyadh, , Saudi Arabia

Belgrade, , Serbia

Novi Sad, , Serbia

Banská Bystrica, , Slovakia

Bratislava, , Slovakia

Košice, , Slovakia

Nitra, , Slovakia

Poprad, , Slovakia

Ljubljana, , Slovenia

Bundang City, , South Korea

Busan, , South Korea

Cheonan, , South Korea

Daegu, , South Korea

Daegu, , South Korea

Daegu, , South Korea

Daejeon, , South Korea

Gwangju, , South Korea

Iksan, , South Korea

Incheon, , South Korea

Kyunggi-do, , South Korea

Pusan, , South Korea

Pusan, , South Korea

Pusan, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Suwon, , South Korea

Falun, , Sweden

Gothenburg, , Sweden

Linköping, , Sweden

Lund, , Sweden

Malmo, , Sweden

Stockholm, , Sweden

Uppsala, , Sweden

Aarau, , Switzerland

Aarau, , Switzerland

Baden, , Switzerland

Chur, , Switzerland

Locarno, , Switzerland

Lucerne, , Switzerland

Zurich, , Switzerland

Changhua, , Taiwan

Kaohsiung City, , Taiwan

Kaohsiung City, , Taiwan

Kaohsiung City, , Taiwan

Taichung, , Taiwan

Taichung, , Taiwan

Tainan City, , Taiwan

Tainan City, , Taiwan

Taipei, , Taiwan

Taipei, , Taiwan

Taipei, , Taiwan

Taipei, , Taiwan

Taipei, , Taiwan

Taoyuan District, , Taiwan

Bangkok, , Thailand

Bangkok, , Thailand

Bangkok, , Thailand

Ankara, , Turkey (Türkiye)

Ankara, , Turkey (Türkiye)

Ankara, , Turkey (Türkiye)

Ankara, , Turkey (Türkiye)

Istanbul, , Turkey (Türkiye)

Istanbul, , Turkey (Türkiye)

Istanbul, , Turkey (Türkiye)

Izmir, , Turkey (Türkiye)

Izmir, , Turkey (Türkiye)

Shhiye, Ankara, , Turkey (Türkiye)

Montevideo, , Uruguay

Caracas, , Venezuela

Caracas, , Venezuela

Countries

Albania; Argentina; Australia; Austria; Belgium; Bosnia and Herzegovina; Brazil; Bulgaria; Chile; China; Colombia; Croatia; Czechia; Ecuador; Egypt; Estonia; Finland; Germany; Greece; Guatemala; Hong Kong; Hungary; India; Indonesia; Ireland; Israel; Italy; Latvia; Lithuania; Malaysia; Mexico; Netherlands; New Zealand; Panama; Peru; Poland; Portugal; Romania; Russia; Saudi Arabia; Serbia; Slovakia; Slovenia; South Korea; Sweden; Switzerland; Taiwan; Thailand; Turkey (Türkiye); Uruguay; Venezuela

References

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.

Reference Type: DERIVED

PMID: 25855621 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21439671 (View on PubMed)

Other Identifiers

2004-000564-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

INC-9042

Identifier Type: OTHER

Identifier Source: secondary_id

MO18109

Identifier Type: -

Identifier Source: org_study_id