A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT00556712 | Completed Phase 3 Results

• 1 other identifier: BO18192
• Study Type: interventional
• Target: 889
• Locations: 26 countries
• Sites: 121

Brief Summary

This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva, compared with placebo, following platinum-based chemotherapy in patients with advanced, recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The anticipated time on study treatment is until disease progression; the target sample size is 500+ individuals.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008)

  Progression-free survival (PFS) was defined as the time from randomization to PD or death, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline (BL) more the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.

  Screening, BL [≤21 days after randomization], every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

• PFS in All Participants (Data Cutoff 17 May 2008)

  The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology.

  Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

• Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)

  PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from BL more the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.

  6 months

• Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008)

  PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.

  Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

• PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008)

  The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.

  Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

• Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008)

  PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.

  6 months

Secondary Outcomes (30)

• Percentage of All Participants Who Died (Data Cutoff 12 January 2012)

  Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months).

• Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012)

  Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)

• Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012)

  1 year

• Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012)

  Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)

• OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012)

  Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)

Study Arms (2)

Erlotinib

EXPERIMENTAL

Participants received erlotinib, 150 milligrams (mg), orally (PO), daily from randomization until progressive disease (PD), death, or unacceptable toxicity.

Drug: erlotinib [Tarceva]

Placebo

PLACEBO COMPARATOR

Participants received a placebo, PO, daily, from randomization until PD, death, or unacceptable toxicity.

Drug: Placebo

Interventions

erlotinib [Tarceva] DRUG

150mg po daily

Erlotinib

Placebo DRUG

po daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients \>=18 years of age;
• histologically documented, locally advanced , recurrent or metastatic NSCLC;
• measurable disease;
• no disease progression after 4 cycles of platinum-based chemotherapy.

You may not qualify if:

• unstable systemic disease;
• any other malignancies in the last 5 years.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (133)

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St Leonards, New South Wales, 2065, Australia

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Waratah, New South Wales, 2298, Australia

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Brisbane, Queensland, 4101, Australia

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Adelaide, South Australia, 5041, Australia

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East Bentleigh, Victoria, VIC 3165, Australia

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Fitzroy, Victoria, 3065, Australia

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Geelong, Victoria, 3220, Australia

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Melbourne, Victoria, 3084, Australia

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Innsbruck, 6020, Austria

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Klagenfurt, 9010, Austria

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Vienna, 1140, Austria

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Vienna, 1145, Austria

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Antwerp, 2020, Belgium

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Edegem, 2650, Belgium

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Winnipeg, Manitoba, R3E 0V9, Canada

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Oshawa, Ontario, L1G 2B9, Canada

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Sault Ste. Marie, Ontario, P6A 2C4, Canada

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Toronto, Ontario, M4C 3E7, Canada

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Laval, Quebec, H7M 3L9, Canada

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Montreal, Quebec, H4J 1C5, Canada

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Santiago, 0000, Chile

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Beijing, 100730, China

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Guangzhou, 510060, China

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Guangzhou, 510080, China

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Shanghai, 200032, China

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České Budějovice, 370 87, Czechia

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Olomouc, 775 20, Czechia

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Pilsen, 305 99, Czechia

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Herlev, 2730, Denmark

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Odense, 5000, Denmark

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Bayonne, 64100, France

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Brest, 29200, France

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Clermont-Ferrand, 63003, France

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Dijon, 21079, France

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Le Mans, 72037, France

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Lille, 59020, France

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Limoges, 87042, France

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Paris, 75674, France

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Paris, 75908, France

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Pau, 64046, France

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Toulouse, 31400, France

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Vandœuvre-lès-Nancy, 54511, France

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Bad Berka, 99437, Germany

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Bochum, 44791, Germany

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Halle, 06120, Germany

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Herne, 44625, Germany

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Neuruppin, 16816, Germany

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Villingen-Schwenningen, 78052, Germany

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Athens, 11527, Greece

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Athens, 14564, Greece

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Heraklion, 71110, Greece

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Budapest, 1122, Hungary

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Budapest, 1125, Hungary

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Budapest, 1529, Hungary

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Deszk, 6772, Hungary

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Nyíregyháza, 4400, Hungary

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Pécs, 7635, Hungary

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Szombathely, 9700, Hungary

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Törökbálint, 2045, Hungary

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Bologna, Emilia-Romagna, 40139, Italy

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Rome, Lazio, 00168, Italy

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Ancona, The Marches, Italy

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Kaunas, Lithuania

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Klaipėda, 92288, Lithuania

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Vilnius, 08660, Lithuania

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George Town, 11200, Malaysia

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Kuala Lumpur, 59100, Malaysia

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Amsterdam, 1081 HV, Netherlands

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Flushing, 4382 EE, Netherlands

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Heerlen, 6419 PC, Netherlands

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Nieuwegein, 3435 CM, Netherlands

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Auckland, 1009, New Zealand

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Christchurch, New Zealand

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Lodz, 91-520, Poland

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Lodz, 94-306, Poland

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Otwock, 05-400, Poland

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Bucharest, 022328, Romania

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Cluj-Napoca, 400015, Romania

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Iași, 6600, Romania

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Timișoara, 1900, Romania

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Arkhangelsk, 163045, Russia

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Balashikha, 143900, Russia

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Chelyabinsk, 454 087, Russia

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Kazan', 420029, Russia

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Kazan', 420111, Russia

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Kirov, Russia

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Krasnodar, 350040, Russia

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Krasnodar, Russia

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Kuzmolovo, 188663, Russia

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Moscow, 105203, Russia

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Moscow, 105229, Russia

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Moscow, 115478, Russia

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Moscow, 117837, Russia

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Moscow, 125284, Russia

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Nizhny Novgorod, 603000, Russia

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Perm, 614 066, Russia

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Saint Petersburg, 191015, Russia

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Saint Petersburg, 195067, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, Russia

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Sashi, 354057, Russia

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Smolensk, Russia

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Yaroslavl, 150054, Russia

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Banská Bystrica, 975 17, Slovakia

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Bratislava, 825 56, Slovakia

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Nitra, 949 88, Slovakia

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Poprad, 058 87, Slovakia

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Golnik, Slovenia

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Ljubljana, 1000, Slovenia

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Maribor, Slovenia

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Durban, 4091, South Africa

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Johannesburg, 2196, South Africa

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Pretoria, 0001, South Africa

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Daegu, 700-712, South Korea

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Seoul, 110-744, South Korea

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Seoul, 120-752, South Korea

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Seoul, 135-710, South Korea

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Seoul, 138-736, South Korea

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Seoul, 139-709, South Korea

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Suwon, South Korea

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Santander, Cantabria, 39008, Spain

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A Coruña, La Coruña, 15006, Spain

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Oviedo, Principality of Asturias, 33006, Spain

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Valencia, Valencia, 46026, Spain

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Zaragoza, Zaragoza, 50009, Spain

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Kharkiv, 61024, Ukraine

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Uzhhorod, 88000, Ukraine

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Zaporizhzhya, 69104, Ukraine

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Chelmsford, CM1 7ET, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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Leicester, LE1 5WW, United Kingdom

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Plymouth, PL6 8DH, United Kingdom

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Caracas, 1062, Venezuela

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Related Publications (1)

• Cappuzzo F, Ciuleanu T, Stelmakh L, Cicenas S, Szczesna A, Juhasz E, Esteban E, Molinier O, Brugger W, Melezinek I, Klingelschmitt G, Klughammer B, Giaccone G; SATURN investigators. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2010 Jun;11(6):521-9. doi: 10.1016/S1470-2045(10)70112-1. Epub 2010 May 20.

  PMID: 20493771 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: January 1, 2006
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 11, 2015
• Results First Posted: February 11, 2015

Record last verified: 2015-01

Locations

ZA (3); KR (7); NZ (2); AU (4); CA (6); DE (6); HU (8); RO (4); LI (3); UA (3); ES (5); GR (3); VE (1); CZ (3); MY (2); PL (3); RU (23); CL (1); NL (4); IT (3); CN (4); FR (12); SL (3); DK (2); GB (4); BE (2)