A Study of Tarceva (Erlotinib) Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

NCT01996332 | Completed Phase 2 Results

• 1 other identifier: ML17915
• Study Type: interventional
• Target: 1,805
• Locations: 1 country
• Sites: 94

Brief Summary

This study will evaluate the efficacy and safety of oral Tarceva in patients with advanced NSCLC for whom Tarceva monotherapy is considered the best therapeutic option. The anticipated time on study treatment is 3-12 months.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Time to Disease Progression or Death by Line of Treatment

  Time to progression or death was defined as the time from inclusion to the date of disease progression or death, whichever occurred first.

  Baseline, every 6-8 weeks up to 3 years until disease progression or death

Secondary Outcomes (2)

• Percentage of Participants Achieving Clinical Benefit by Line of Treatment

  Baseline, every 6-8 weeks up to 3 years or until death

• Overall Survival (OS) by Line of Treatment

  Baseline, every 6-8 weeks up to 3 years, or until death

Study Arms (1)

Tarceva Arm

EXPERIMENTAL

Drug: erlotinib [Tarceva]

Interventions

erlotinib [Tarceva] DRUG

150 mg/day until progressive disease or unacceptable toxicity

Tarceva Arm

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;
• locally advanced or metastatic NSCLC (Stage IIIB or IV);
• not a candidate for curative surgery or radical chemotherapy;
• no brain metastases, or clinically stable metastases for \>=2 months.

You may not qualify if:

• radiotherapy over the previous 2 weeks;
• weight loss \>10% in the previous 6 weeks.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (94)

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Alcoy, Alicante, 03804, Spain

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Alicante, Alicante, 3010, Spain

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Elche, Alicante, 03203, Spain

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Almería, Almeria, 04009, Spain

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Ávila, Avila, 05071, Spain

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Badajoz, Badajoz, 06080, Spain

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Don Benito, Badajoz, 06400, Spain

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Mérida, Badajoz, 06800, Spain

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Ibiza Town, Balearic Islands, 07800, Spain

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Palma de Mallorca, Balearic Islands, 07012, Spain

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Palma de Mallorca, Balearic Islands, 07014, Spain

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Palma de Mallorca, Balearic Islands, 07198, Spain

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Badalona, Barcelona, 08911, Spain

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Barcelona, Barcelona, 08003, Spain

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Barcelona, Barcelona, 08017, Spain

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Barcelona, Barcelona, 08022, Spain

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Barcelona, Barcelona, 08029, Spain

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Barcelona, Barcelona, 08036, Spain

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Barcelona, Barcelona, 08041, Spain

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Barcelona, Barcelona, 08227, Spain

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Barcelona, Barcelona, 08907, Spain

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Barcelona, Barcelona, 08916, Spain

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Granollers, Barcelona, 08400, Spain

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Manresa, Barcelona, 08243, Spain

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Mataró, Barcelona, 08304, Spain

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Sabadell, Barcelona, Barcelona, 08208, Spain

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Sant Coloma Gramenet, Barcelona, 08923, Spain

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Sant Pere de Ribes, Barcelona, 08810, Spain

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Terrassa, Barcelona, 08221, Spain

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Vic, Barcelona, 08500, Spain

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Burgos, Burgos, 09006, Spain

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Cáceres, Caceres, 10003, Spain

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Algeciras, Cadiz, 11207, Spain

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Cadiz, Cadiz, 11009, Spain

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Jerez de la Frontera, Cadiz, 11407, Spain

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Puerto Real, Cadiz, 11510, Spain

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Santander, Cantabria, 39008, Spain

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Torrevieja, Cantabria, 03180, Spain

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Castellon, Castellon, 12002, Spain

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Córdoba, Cordoba, 14004, Spain

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Girona, Girona, 17007, Spain

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Baza, Granada, 18800, Spain

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Granada, Granada, 18003, Spain

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Granada, Granada, 18014, Spain

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Donostia / San Sebastian, Guipuzcoa, 20014, Spain

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Huelva, Huelva, 21005, Spain

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Jaén, Jaen, 23007, Spain

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A Coruña, La Coruña, 15006, Spain

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A Coruña, La Coruña, 15009, Spain

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Ferrol, La Coruña, 15405, Spain

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Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

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Las Palmas de Gran Canaria, Las Palmas, 35020, Spain

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León, Leon, 24071, Spain

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Lleida, Lerida, 25198, Spain

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Lugo, Lugo, 27004, Spain

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Alcorcón, Madrid, 28922, Spain

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Madrid, Madrid, 28002, Spain

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Madrid, Madrid, 28006, Spain

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Madrid, Madrid, 28033, Spain

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Madrid, Madrid, 28034, Spain

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Madrid, Madrid, 28040, Spain

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Madrid, Madrid, 28041, Spain

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Madrid, Madrid, 28046, Spain

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Madrid, Madrid, 28222, Spain

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Madrid, Madrid, 28660, Spain

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Madrid, Madrid, 28935, Spain

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Málaga, Malaga, 29010, Spain

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Cartagena, Murcia, 30203, Spain

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Murcia, Murcia, 30008, Spain

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Murcia, Murcia, 30120, Spain

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Navarra, Navarre, 31008, Spain

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Pamplona, Navarre, 31008, Spain

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Ourense, Orense, 32005, Spain

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Palencia, Palencia, 34005, Spain

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Vigo, Pontevedra, 36204, Spain

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Vigo, Pontevedra, 36211, Spain

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Salamanca, Salamanca, 37007, Spain

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Segovia, Segovia, 40002, Spain

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Seville, Sevilla, 41009, Spain

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Seville, Sevilla, 41013, Spain

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Seville, Sevilla, 41014, Spain

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San Cristóbal de La Laguna, Tenerife, 38320, Spain

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Santa Cruz de Tenerife, Tenerife, 38010, Spain

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Sagunto, Valencia, 46520, Spain

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Valencia, Valencia, 41014, Spain

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Valencia, Valencia, 46009, Spain

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Valencia, Valencia, 46010, Spain

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Valencia, Valencia, 46015, Spain

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Valencia, Valencia, 46017, Spain

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Valencia, Valencia, 46026, Spain

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Valladolid, Valladolid, 47010, Spain

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Barakaldo, Vizcaya, 48903, Spain

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Bilbao, Vizcaya, 48013, Spain

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Zaragoza, Zaragoza, 50009, Spain

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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

Limitations and Caveats

Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann- LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: November 27, 2013
• Study Start: April 1, 2004
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: July 10, 2014
• Results First Posted: July 10, 2014

Record last verified: 2014-06

Locations

ES (94)