Clinical Trial 17969

Cancer Type: Thoracic
Interventions:Erlotinib; Placebo; Tarceva (Erlotinib)

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Jhanelle Gray

Overview

Study Title

Randomized Study of Erlotinib vs. Observation in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)

Summary

The purpose of this study is to compare any good and bad effects participants may have when treated with the standard treatment against participants who are treated with the standard treatment plus erlotinib (an investigational drug).

Objective

1 Primary Objective: To assess whether adjuvant therapy with erlotinib will result in improved Overall Survival (OS) over placebo for patients with completely resected stage IB (>/=4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy. 2 Secondary Objectives: 2.1 To assess whether adjuvant therapy with erlotinib will result in improved Disease Free Survival (DFS) over placebo for patients with completely resected stage IB (>/=4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy, both overall and within the stage subgroups: IB and II/IIIA. 2.2 To evaluate the safety profile of erlotinib in the adjuvant setting. 2.3 To assess whether adjuvant therapy with erlotinib will result in improved DFS rate at 2 years, and OS rate at 5 years over placebo for patients with completely resected stage IB (>/= 4cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy, both overall and within the stage subgroups: IB and II/IIIA. 2.4 To assess the primary and secondary objectives in all randomized patients, regardless of central confirmation of the EGFR mutant status.

Inclusion Criteria

  • Previously registered to A151216 with a result of EGFR exon 19 deletion or L858R mutation. > Completely resected stage IB (>/= 4 cm), II or IIIA non-squamous Non-small Cell Lung Cancer (NSCLC) with negative margins.
  • Complete recovery from surgery and standard post-operative therapy (if applicable).
  • No interstitial fibrosis or lung disease.
  • Age >/=18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • No prior or concurrent malignancies within 5 years, except non-melanoma skin carcinoma or in situ carcinomas.
  • Non-pregnant and non-lactating.
  • Must Meet Required Laboratory Eligibility

  • Exclusion Criteria

  • Does not meet Inclusion Criteria