A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression

NCT01230710 | Completed Phase 4 Results

• 1 other identifier: ML25478
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 7

Brief Summary

This open-label, single-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer who have completed 4 cycles of standard platinum-based chemotherapy without progression. Patients will receive Tarceva at a dose of 150 mg orally daily until disease progression or unacceptable toxicity occurs.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Progression-free Survival at Week 52

  A participant had progression-free survival if they did not have disease progression and were alive. Tumor assessments were done by magnetic resonance imaging according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.

  From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months).

Secondary Outcomes (4)

• Progression-free Survival (PFS)

  From the date of enrolment until the end of the study (up to 2 years, 6 months).

• Overall Survival

  From the date of enrolment until the end of the study (up to 2 years, 6 months).

• Percentage of Participants With a Complete Response (CR) or a Partial Response (PR)

  From the date of enrolment until the end of the study (up to 2 years, 6 months).

• Percentage of Participants With Disease Control

  From the date of enrolment until the end of the study (up to 2 years, 6 months).

Study Arms (1)

Erlotinib

EXPERIMENTAL

Participants received erlotinib 150 mg orally once a day for 48 weeks.

Drug: Erlotinib

Interventions

Erlotinib DRUG

Erlotinib was supplied as tablets.

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:

• Adult patients ≥ 18 years of age.
• Histologically documented non-small cell lung cancer (NSCLC).
• Locally advanced or recurrent (Stage IIIB) or metastatic (Stage IV) disease.
• Completion of 4 cycles of an acceptable, standard, platinum-based chemotherapy doublet without progression.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Patients of reproductive potential must agree to use effective contraception.

You may not qualify if:

• Prior exposure to agents directed at the human epidermal growth factor receptor (HER) axis (eg, gefitinib, cetuximab, trastuzumab).
• Prior treatment with any monoclonal antibody therapy.
• Any other malignancies within the previous 5 years, except for adequately treated carcinoma in situ of the cervix or squamous cell skin cancer.
• Clinically significant cardiovascular, hepatic, renal, or metabolic disease or active infection
• Pre-existing interstitial lung disease.
• Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
• Pregnant or lactating women.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (7)

Unknown Facility

Bangalore, 560027, India

Location

Unknown Facility

Chennai, 600035, India

Location

Unknown Facility

Delhi, 110085, India

Location

Unknown Facility

Hyderabad, 500 034, India

Location

Unknown Facility

Jaipur, 302 017, India

Location

Unknown Facility

Kolkata, 700026, India

Location

Unknown Facility

Nashik, 422005, India

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

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 DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: October 29, 2010
• Study Start: March 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 30, 2015
• Results First Posted: March 30, 2015

Record last verified: 2015-03

Locations

IN (7)