A Study of Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer Naive to Chemotherapy

NCT02013206 | Completed Phase 2 Results

• 1 other identifier: MO18660
• Study Type: interventional
• Target: 52
• Locations: 6 countries
• Sites: 11

Brief Summary

This study will evaluate the efficacy and safety of Tarceva in two groups of patients with non-small cell lung cancer who have not been pre-treated with chemotherapy. One group, consisting of patients who have never smoked, will receive Tarceva 150 mg/day, and the other group, consisting of current/former smokers, will receive Tarceva 150 mg/day increasing to a maximum of 300 mg/day. The anticipated time on study treatment is 1-2 years.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Non-Progression Rate (NPR) at 8 Weeks

  Non-Progressive Rate (NPR) was defined as the percentage of participants without progression (had stable disease (SD) or better) based on (Response Evaluation Criteria in Solid Tumours (RECIST) criteria 8 weeks after start of treatment. Diagnosis of Progressive Disease (PD) was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions. PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

  Week 8

Secondary Outcomes (7)

• Objective Response Rate

  Up to 2 years

• Disease Control Rate

  Up to 2 years

• Duration of Response

  Up to 2 years

• Time to Progression

  Up to 2 years

• Progression-Free Survival

  Up to 2 years

Study Arms (2)

Never Smokers

EXPERIMENTAL

Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib \[Tarceva\] 150 mg orally daily until disease progression or unacceptable toxicity.

Drug: erlotinib [Tarceva]

Current/Former Smokers

EXPERIMENTAL

Current Smokers (participants who smoked \> 100 cigarettes in entire lifetime and either quit smoking \< 1 year ago or were currently smoking) or Former Smokers (participants who smoked \> 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib \[Tarceva\] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.

Drug: erlotinib [Tarceva]

Interventions

erlotinib [Tarceva] DRUG

Erlotinib tablets taken orally once daily in the morning.

Also known as: Tarceva

Current/Former Smokers; Never Smokers

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 advanced non-small cell lung cancer (stage IIIB/IV);
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
• no previous chemotherapy.

You may not qualify if:

• previous therapy which acts on Epidermal Growth Factor Receptor (EGFR) axis;
• clinical evidence of brain metastasis;
• any unstable systemic disease;
• unable to take oral medication;
• any significant ophthalmological abnormality.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (11)

Unknown Facility

Marseille, 13274, France

Location

Unknown Facility

Villejuif, 94805, France

Location

Unknown Facility

Hamburg, 22045, Germany

Location

Unknown Facility

Milan, 20162, Italy

Location

Unknown Facility

Rozzano, 20089, Italy

Location

Unknown Facility

Amsterdam, 1105 AZ, Netherlands

Location

Unknown Facility

Maastricht, 6229 HX, Netherlands

Location

Unknown Facility

Barcelona, 08035, Spain

Location

Unknown Facility

Barcelona, 08907, Spain

Location

Unknown Facility

Madrid, 28041, Spain

Location

Unknown Facility

Manchester, M2O 4BX, United Kingdom

Location

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

Treatment was ongoing for 3 patients at the time of the Clinical Study Report (CSR) cut-off. In the addendum to the CSR, there were no findings for these 3 patients that deviated from those observed in the original report.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: December 17, 2013
• Study Start: September 1, 2006
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: December 19, 2014
• Results First Posted: December 19, 2014

Record last verified: 2014-12

Locations

NL (2); ES (3); GB (1); FR (2); IT (2); DE (1)