Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients With Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)

Overview

This randomized phase III trial studies how well erlotinib hydrochloride compared to placebo works in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery.

Description

The purpose of this study is to assess whether adjuvant therapy with erlotinib (erlotinib hydrochloride) will result in improved overall survival (OS) over placebo for patients with completely resected stage IB (>= 4 cm)-IIIA epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) (confirmed centrally) following complete resection and standard post-operative therapy.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions: lung cancer
  • Age: Between 18 Years - 100 Years
  • Gender: Male or Female

Inclusion Criteria
Previously registered to A151216, with the result of lung cancer harboring an EGFR exon 19 deletion or L858R mutation; the testing must have been performed by one of the following criteria:
Patient registered to A151216 and the assessment performed centrally by the protocol specified laboratory
By a local Clinical Laboratory Improvement Amendments (CLIA) certified laboratory; the report must indicate the result as well as the CLIA number of the laboratory that performed the assay; these patients will also have been registered to A151216, but can be enrolled on A081105 regardless of the central lab results
Patients that are both EGFR mutant and anaplastic lymphoma kinase (ALK) rearrangements will be registered to A081105
Completely resected stage IB (>= 4 cm), II or IIIA non-squamous NSCLC with negative margins
Complete recovery from surgery and standard post-operative therapy (if required); patients must be completely recovered from surgery at the time of randomization; the minimum time requirement between date of surgery and randomization must be at least 28 days, the maximum time requirement between surgery and randomization must be 90 days if no adjuvant chemotherapy was administered, 240 days if adjuvant chemotherapy was administered, and 300 days if adjuvant chemotherapy and radiation therapy was administered
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Exclusion Criteria
Patients with known resistant mutations in the EGFR tyrosine-kinase (TK) domain (T790M)
Prior or concurrent malignancies within 5 years, except non-melanoma skin carcinoma and in situ carcinomas
pregnant or lactating
History of cornea abnormalities


Additional Information:
Participants will not be paid for their participation.

Updated on 20 Nov 2022 . Study ID: TX7270

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