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Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2

O

OSI Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Combination carboplatin and paclitaxel
Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00085839
OSI-774-201

Details and patient eligibility

About

The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population.

Enrollment

103 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Stage IIIB or IV Nonsmall cell lung cancer (NSCLC)
  • No prior chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 2
  • Clinically or radiologically measurable disease per RECIST criteria

Exclusion criteria

  • Gastro-intestinal abnormalities
  • Any concurrent anticancer therapy
  • Prior treatment with epidermal growth factor receptor (EGFR) inhibitors of any kind
  • Other active malignancies
  • Uncontrolled brain metastases
  • Severe abnormalities of the cornea
  • Significant cardiac disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

103 participants in 2 patient groups

Erlotinib
Experimental group
Description:
Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
Treatment:
Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)
Standard Chemotherapy
Active Comparator group
Description:
Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
Treatment:
Drug: Combination carboplatin and paclitaxel

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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