A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations

NCT01260181 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: ML254342010-022509-17
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 9

Brief Summary

This single arm, open-label study will evaluate the efficacy and safety of erlotinib (Tarceva) in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Objective Response (Complete Response [CR]/Partial Response [PR]) Based on Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1

  Objective response (OR) was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of complete response (CR) and partial response (PR) four at least 4 weeks during treatment. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

  Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years])

Secondary Outcomes (5)

• Progression Free Survival (PFS) Based on CT or MRI According to RECIST v 1.1

  Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years])

• Overall Survival

  Baseline up to 5 years

• Percentage of Participants With Adverse Events

  Baseline up to 5 years

• Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation in Study Population

  Screening (21 days prior to Day 1)

• Median Time Taken From the First Response Until Disease Progression Based on RECIST v 1.1 as Determined by the Investigator

  Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years])

Study Arms (1)

Erlotinib

EXPERIMENTAL

Participants will receive erlotinib 150 millgrams (mg) orally daily until disease progression.

Drug: Erlotinib

Interventions

Erlotinib DRUG

Erlotinib 150 mg tablet will be given orally daily.

Erlotinib

Eligibility Criteria

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

You may qualify if:

• Locally advanced or metastatic NSCLC with EGFR mutations
• Measurable disease according to RECIST criteria
• Adequate hematological, renal and liver function

You may not qualify if:

• Previous chemotherapy or therapy against EGFR for metastatic disease
• Symptomatic cerebral metastases
• Pre-existing disease of the lung parenchyma such as lung fibrosis, lymphangitic carcinomatosis
• History of another malignancy except for carcinoma in-situ of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
• Concomitant use of coumarins

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (9)

Hospital Infante D. Pedro; Servico de Oncologia Medica

Aveiro, 3814-501, Portugal

Location

Hospital Geral; Servico de Pneumologia

Coimbra, 3041-801, Portugal

Location

IPO de Lisboa; Servico de Pneumologia

Lisbon, 1099-023, Portugal

Location

Hospital Santo Antonio dos Capuchos;Servico de Oncologia Medica

Lisbon, 1150-314, Portugal

Location

Hospital de Santa Maria; Servico de Pneumologia

Lisbon, 1600, Portugal

Location

Hospital Pulido Valente; Servico de Pneumologia

Lisbon, 1796-001, Portugal

Location

IPO do Porto; Servico de Oncologia Medica

Porto, 4200-072, Portugal

Location

Hospital de Sao Joao; Servico de Pneumologia

Porto, 4200, Portugal

Location

CHVNG/E_Unidade 1; Servico de Pneumologia

Vila Nova de Gaia, 4434-502, Portugal

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 DIRECTOR

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: December 13, 2010
• First Posted: December 15, 2010
• Study Start: March 31, 2011
• Primary Completion: September 29, 2017
• Study Completion: September 29, 2017
• Last Updated: October 31, 2018
• Results First Posted: October 26, 2018

Record last verified: 2018-10

Locations

PT (9)