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CompletedPhase 3NCT00153803
Official study title

Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)

Study summary

This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated agent following concurrent chemoradiation and prior to the emergence of drug resistance will prolong the progression-free survival by 40% (10 months → 14 months).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedErlotinib (tarceva) and Placebo

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 6, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?65 U.S. locations

Locations may change over time.

Who runs it?Dartmouth-Hitchcock Medical Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Dartmouth-Hitchcock Medical Center
Interventions being studied
Drug: Erlotinib (tarceva); Drug: Placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Early-stage or resectable→Locally advanced→
Treatment approach
Chemotherapy→Radiation therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Unresectable, stage IIIA or IIIB NSCLC (measurable disease is not required)
  • No evidence of metastatic disease
  • No prior treatment
  • Adequate organ function
  • Adequate pulmonary function (FEV \>= 1.0L or predicted FEV \>0.8L)
Reasons someone may not be able to joinExclusion criteria
  • Metastasis
  • Prior treatment
  • Malignant pleural or pericardial effusion
  • Peripheral neuropathy \>= grade 2

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Birmingham Hematology and Oncology Associates, LLCBirmingham, Alabama
  • Oncology Specialties, P.C.Huntsville, Alabama
  • Cooper ClinicFort Smith, Arkansas
  • Genesis Cancer CenterHot Springs, Arkansas
  • Alta Bates Comprehensive Cancer CenterBerkeley, California
  • Northstate Cancer SpecialityRedding, California
  • Mercy General HospitalSacramento, California
  • St. Francis Hospital Cancer CenterHartford, Connecticut
  • Connecticut Oncology GroupMiddletown, Connecticut
  • George Bray Cancer Center/New Britain General HospitalNew Britain, Connecticut
  • Oncology and Hematology Associates, PCNew London, Connecticut
  • Whittingham Cancer Center at Norwalk HospitalNorwalk, Connecticut

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 6, 2019. Always confirm current availability with the study team.

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