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

NCT02774278 | Completed Phase 2 Results

• 2 other identifiers: BO182792004-005096-42
• Study Type: interventional
• Target: 264
• Locations: 13 countries
• Sites: 26

Brief Summary

This study will assess potentially predictive markers of efficacy in participants with NSCLC receiving oral erlotinib (Tarceva) therapy. The anticipated time on study treatment is until disease progression, unacceptable toxicity or death.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Number of Differentially Expressed Genes Associated With Clinical Benefit

  Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Clinical benefit is defined in the Outcome Measure 5.

  Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years

• Number of Epidermal Growth Factor Receptor (EGFR) Mutation Participants Who Achieved Clinical Benefit

  Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with EGFR mutation (L858R/ exon 19 deletion) and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5.

  Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years

• Number of KRAS Mutation Participants Who Achieved Clinical Benefit

  Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with KRAS gene mutation and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5.

  Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years

Secondary Outcomes (2)

• Percentage of Participants With Overall Response of Complete Response (CR) or Partial Response (PR) Using Response Evaluation Criteria in Solid Tumors (RECIST)

  Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years

• Percentage of Participants With Clinical Benefit (CR, PR, or Stable Disease [SD] for at Least 12 Weeks After Study Entry) Using RECIST

  Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years

Study Arms (1)

Erlotinib

EXPERIMENTAL

Participants will receive erlotinib orally daily until disease progression, unacceptable toxicity or death.

Drug: Erlotinib

Interventions

Erlotinib DRUG

Erlotinib will be administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.

Also known as: Tarceva

Erlotinib

Eligibility Criteria

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

You may qualify if:

• Advanced NSCLC
• Tumor accessible for biopsy by bronchoscopy
• Disease progression following course of standard chemotherapy, or participants unwilling/unable to undergo chemotherapy

You may not qualify if:

• Unstable systemic disease
• Any other malignancies in the last 5 years
• Brain metastases
• Previous treatment with therapy acting on the epidermal growth factor receptor (EGFR) axis

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (29)

Unknown Facility

Brussels, B-1200, Belgium

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Sofia, 1756, Bulgaria

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Tallinn, 11619, Estonia

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Tartu, 51014, Estonia

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Montpellier, 34295, France

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Paris, 75970, France

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Cologne, 50937, Germany

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Großhansdorf, 22927, Germany

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Hong Kong, Hong Kong

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Dublin, 8, Ireland

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Perugia, 06132, Italy

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Gdansk, 80-214, Poland

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Lodz, 94-306, Poland

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Lublin, 20-950, Poland

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Poznan, 60-569, Poland

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Moscow, 105229, Russia

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Moscow, 107005, Russia

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Moscow, 115478, Russia

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Saint Petersburg, 197089, Russia

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Saint Petersburg, 197758, Russia

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Saint Petersburg, 198255, Russia

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Singapore, 169610, Singapore

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Barcelona, 08035, Spain

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Barcelona, 08916, Spain

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Madrid, 28041, Spain

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Taipei, 00112, Taiwan

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Taipei, 105, Taiwan

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Taipei, 106, Taiwan

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Weston-super-Mare, BS23 4TQ, United Kingdom

Location

MeSH Terms

Interventions

Erlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 17, 2016
• Study Start: July 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 8, 2016
• Results First Posted: August 2, 2016

Record last verified: 2016-08

Locations

RU (6); BE (1); DE (2); PL (4); BU (1); FR (2); SG (1); ES (2); TW (3); HK (1); IE (1); IT (1); GB (1)