A Study of First-line Maintenance Tarceva (Erlotinib) Versus Tarceva at Time of Disease Progression in Patients With Advanced Non-small Cell Lung Cancer After Chemotherapy

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: April 4, 2011
Last updated: December 1, 2015
Last verified: December 2015
This double-blind, placebo-controlled study will evaluate the benefit of first-line maintenance Tarceva (erlotinib) versus Tarceva at the time of disease progression in patients with advanced non-small cell lung cancer (NSCLC) who have not progressed following 4 cycles of platinum based-chemotherapy and whose tumour does not harbor an EGFR activating mutation. Patients will be randomized to receive either Tarceva 150 mg orally daily or placebo until disease progression or unacceptable toxicity occurs. Patients who progressed on placebo will receive Tarceva 150 mg orally daily in second line until disease progression or unacceptable toxicity. Anticipated time on study treatment is up to 42 months.

Condition Intervention Phase
Non-Squamous Non-Small Cell Lung Cancer
Drug: Placebo
Drug: erlotinib [Tarceva]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of First-line Maintenance Tarceva vs Tarceva at the Time of Disease Progression in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following 4 Cycles of Platinum-based Chemotherapy

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival (OS): First-line maintenance Tarceva versus Tarceva at time of disease progression [ Time Frame: 42 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival (PFS): First-line maintenance Tarceva versus placebo (tumour assessments according to RECIST criteria) [ Time Frame: 42 months ] [ Designated as safety issue: No ]
  • Overall response rate (ORR): First-line maintenance Tarceva versus placebo [ Time Frame: 42 months ] [ Designated as safety issue: No ]
  • Disease control rate (DCR): First-line maintenance Tarceva versus placebo [ Time Frame: 42 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 42 months ] [ Designated as safety issue: No ]

Enrollment: 643
Study Start Date: September 2011
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A first line maintenance Drug: erlotinib [Tarceva]
150 mg orally daily, first-line maintenance until disease progression
Placebo Comparator: B placebo Drug: Placebo
orally daily, first-line maintenance until disease progression
Experimental: C second line Drug: erlotinib [Tarceva]
150 mg orally daily, second-line after disease progression on placebo, until disease progression


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

Inclusion Criteria:

  • Adult patients, >/= 18 years of age (or >/= legal age of consent if greater than 18)
  • Advanced or recurrent (Stage IIIb) or metastatic (Stage IV) non-small cell lung cancer (NSCLC)
  • Completion of 4 cycles of platinum-based chemotherapy without progression (end of last chemotherapy cycle </= 28 days prior to randomization)
  • ECOG performance status 0-1

Exclusion Criteria:

  • Prior exposure to agents directed at HER axis (e.g. erlotinib, gafitinib, cetuximab)
  • Patients whose tumours harbour an EGFR activating mutation
  • Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease before screening (platinum-based chemotherapy)
  • Use of pemetrexed in maintenance setting (pemetrexed is allowed during the chemotherapy run-in)
  • Patients who have undergone complete tumour resection after responding to the platinum-based chemotherapy during the screening phase
  • Any other malignancies within 5 years, except for curatively resected carcinoma in situ of the cervix, basal or squamous cell skin cancer, ductal carcinoma in situ or organ confined prostate cancer
  • CNS metastases or spinal cord compression that has not been definitely treated with surgery and/or radiation, or treated CNS metastases or spinal cord compression without stable disease for >/= 2 months
  • HIV, hepatitis B or hepatitis C infection
  • Any inflammatory changes of the surface of the eye
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01328951

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United States, California
Gilroy, California, United States, 95020
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Missouri
Kansas City, Missouri, United States, 64132
United States, Montana
Missoula, Montana, United States, 59802
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
United States, Ohio
Dayton, Ohio, United States, 45420
United States, Tennessee
Chattanooga, Tennessee, United States, 37404
United States, Washington
Spokane, Washington, United States, 99218
Tacoma, Washington, United States, 98405
Belo Horizonte, MG, Brazil, 30150-281
Ijuí, RO, Brazil, 98700-000
Lajeado, RS, Brazil, 95900-000
Porto Alegre, RS, Brazil, 90470340
Porto Alegre, RS, Brazil, 90020-090
Porto Alegre, RS, Brazil, 90035-003
Porto Alegre, RS, Brazil, 90430-090
Florianopolis, SC, Brazil, 88034-000
Santo André, SP, Brazil, 09060-650
Gabrovo, Bulgaria, 5300
Haskovo, Bulgaria, 6300
Plovdiv, Bulgaria, 4004
Ruse, Bulgaria, 7000
Sofia, Bulgaria, 1233
Sofia, Bulgaria, 1303
Sofia, Bulgaria, 1527
Sofia, Bulgaria, 1606
Sofia, Bulgaria, 1756
Sofia, Bulgaria, 1784
Varna, Bulgaria, 9010
Canada, Ontario
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
Canada, Saskatchewan
Regina, Saskatchewan, Canada, S4T 7T1
Quebec, Canada, G1V 4G5
Beijing, China, 100142
Beijing, China, 100730
Changchun, China, 130012
Fuzhou, China, 350014
Guangzhou, China, 510515
Guangzhou, China
Harbin, China, 150081
Shanghai, China, 200030
Shanghai, China, 200433
Shantou, China, 515041
Shenyang, China, 110001
Suzhou, China, 215004
Tianjin, China, 300060
Wuhan, China, 430071
Xi'an, China, 710061
Czech Republic
Ceske Budejovice, Czech Republic, 370 87
Jindrichuv Hradec, Czech Republic, 377 01
Nymburk, Czech Republic, 288 01
Ostrava - Poruba, Czech Republic, 708 52
Praha, Czech Republic, 150 06
Praha 8, Czech Republic, 180 81
Tabor, Czech Republic, 390 03
Bayonne, France, 64109
Compiegne, France, 60321
Gap, France, 05007
Libourne, France, 33505
Lille, France, 59020
Nantes, France, 44202
St Brieuc, France, 22027
Villefranche-sur-Saone, France, 69655
Budapest, Hungary, 1145
Budapest, Hungary, 1122
Budapest, Hungary, 1125
Budapest, Hungary, 1121
Deszk, Hungary, 6772
Farkasgyepu, Hungary, 8582
Gyor, Hungary, 9024
Gyula, Hungary, 5703
Matrahaza, Hungary, 3233
Miskolc, Hungary, 3526
Szolnok, Hungary, 5000
Székesfehérvár, Hungary, 8000
Torokbalint, Hungary, 2045
Zalaegerszeg, Hungary, 8900
Avellino, Campania, Italy, 83100
Bologna, Emilia-Romagna, Italy, 40138
Parma, Emilia-Romagna, Italy, 43100
Roma, Lazio, Italy, 00151
Roma, Lazio, Italy, 00144
Roma, Lazio, Italy, 00168
Legnago, Lombardia, Italy, 37045
Treviglio, Lombardia, Italy, 24047
S. Giovanni Rotondo, Puglia, Italy, 71013
Livorno, Toscana, Italy, 57124
Pisa, Toscana, Italy, 56100
Verona, Veneto, Italy, 37134
Korea, Republic of
Gyeonggi-do, Korea, Republic of, 463-707
Seoul, Korea, Republic of, 03722
Seoul, Korea, Republic of, 06351
Seoul, Korea, Republic of, 150-713
Suwon, Korea, Republic of, 442-723
Daugavpils, Latvia, 5417
Riga, Latvia, LV-1079
Riga, Latvia, LV1002
Kaunas, Lithuania, 50009
Vilnius, Lithuania, 08660
Arnhem, Netherlands, 6800 TA
Heerlen, Netherlands, 6419 PC
Hoorn, Netherlands, 1625 HV
Sittard-Geleen, Netherlands, 6162 BG
Zutphen, Netherlands, 7207 AE
Brzozów, Poland, 36-200
Krakow, Poland, 31-115
Poznan, Poland, 60-569
Wodzislaw Slaski, Poland, 44-300
Zamosc, Poland, 22-400
Baia Mare, Romania, 430031
Braila, Romania, 810325
Brasov, Romania, 500091
Brasov, Romania, 500152
Bucuresti, Romania, 010976
Bucuresti, Romania, 022328
Cluj-Napoca, Romania, 400015
Cluj-Napoca, Romania, 400058
Cluj-Napoca, Romania, 400132
Oradea, Romania, 410167
Ploiesti, Romania, 100337
Targu-Mures, Romania, 540136
Banska Bystrica, Slovakia, 975 17
Bardejov, Slovakia, 085 01
Kosice, Slovakia, 04001
Nove Zamky, Slovakia, 940 02
Poprad, Slovakia, 058 01
Rimavska Sobota, Slovakia, 97901
South Africa
Cape Town, South Africa, 7570
Cape Town, South Africa, 7700
George, South Africa, 6530
Port Elizabeth, South Africa, 6045
Pretoria, South Africa, 0002
Kaohsiung, Taiwan, 00833
Taichung, Taiwan, 40447
Taichung, Taiwan, 40705
Taipei, Taiwan, 112
Taipei, Taiwan, 100
Taipei, Taiwan, 11490
Taipei, Taiwan, 00112
Bangkok, Thailand, 10700
Hat Yai, Thailand, 90110
Muang, Thailand, 57000
Muang, Thailand, 50200
Dnipropetrovsk, Ukraine, 49102
Donetsk, Ukraine, 83092
Kharkiv, Ukraine, 61024
Kirovograd, Ukraine, 25011
Kyiv, Ukraine, 03022
Kyiv, Ukraine, 03115
Kyiv, Ukraine, 04107
Lutsk, Ukraine, 63000
Sumy, Ukraine, 40005
Uzhgorod, Ukraine, 88000
Vinnytsya, Ukraine, 21029
Zaporizhzhya, Ukraine, 69040
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01328951     History of Changes
Other Study ID Numbers: BO25460 
Study First Received: April 4, 2011
Last Updated: December 1, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on February 07, 2016