A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Unresectable Advanced and/or Metastatic Non-Small Cell Lung Cancer

NCT00701558 | Completed Phase 2 Results

• 2 other identifiers: ML209512007-002135-83
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This single arm study will assess the efficacy and safety of erlotinib + gemcitabine in chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell lung cancer. Participants will receive erlotinib 150 mg orally (po) daily, in combination with gemcitabine 1000 mg/m\^2 intravenously (iv) weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Conditions

Non-small Cell Lung Cancer Metastatic

Outcome Measures

Primary Outcomes (2)

• Time to Disease Progression

  Time to disease progression or progression free survival (PFS) was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.

  From the time of randomization until disease progression or death (up to 193 weeks)]

• Overall Response Rate (ORR)

  Overall response rate was defined as the percentage of participants who had any evidence of confirmed objective complete response (CR) or partial response (PR), per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) and assessed by computed tomography imaging (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  From the time of randomization until disease progression or death (up to 193 weeks)

Secondary Outcomes (1)

• Overall Survival

  From the time of randomization until death (up to 193 weeks)

Study Arms (1)

Erlotinib + Gemcitabine

EXPERIMENTAL

Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m\^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.

Drug: Erlotinib; Drug: Gemcitabine

Interventions

Erlotinib DRUG

150 mg po daily

Also known as: Tarceva

Erlotinib + Gemcitabine

Gemcitabine DRUG

1000 mg/m\^2 iv on days 1, 8, 15 of each 4 week cycle for 6 cycles

Erlotinib + Gemcitabine

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;
• advanced and/or metastatic (stage IIIB/IV) unresectable non-small cell lung cancer;
• no previous systemic chemotherapy, radiation therapy or immunotherapy;
• Eastern Cooperative Oncology Group (ECOG) \>=2.

You may not qualify if:

• prior systemic anti-tumor therapy with human epidermal growth factor receptor 1 (HER1/EGFR) inhibitors;
• active, non-controlled systemic disease;
• any other malignancies within 5 years (except for adequately treated cancer in situ of cervix, or basal or squamous cell skin cancer).

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Bucharest, 022328, Romania

Location

MeSH Terms

Interventions

Erlotinib Hydrochloride; Gemcitabine

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

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: June 18, 2008
• First Posted: June 19, 2008
• Study Start: August 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 24, 2016
• Results First Posted: May 19, 2016

Record last verified: 2016-05

Locations

RO (1)