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)

Investigating the Effectiveness of Investigational Medication for Non-Small Cell Lung Cancer

Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

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.

Detailed description of study

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.

Participants will not be paid for their participation.

Eligibility of study

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

  • Conditions: non-small cell lung cancer,non small cell lung cancer,non-small cell,non small cell,NSCLC,lung cancer,lung,lungs,cancer,oncology
  • Age: 18 years - 100 years
  • Gender: All

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

Updated on 19 Feb 2024. Study ID: 1502830413 (A081105)

This study investigates the effectiveness of an investigational medication compared to a placebo in treating patients with stage IB-IIIA non-small cell lung cancer (NSCLC) that has been completely removed by surgery. Non-small cell lung cancer is a type of lung cancer that grows and spreads more slowly than small cell lung cancer. The study focuses on patients whose cancer has specific changes in the epidermal growth factor receptor (EGFR) gene, which can affect how cancer cells grow and divide.

Participants in this study will be randomly assigned to receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will evaluate if taking the investigational medication after surgery and standard treatments can improve overall survival compared to taking a placebo.

  • Who can participate: Adults who have had surgery to completely remove stage IB-IIIA non-small cell lung cancer with certain EGFR mutations can participate. Participants must have a good performance status and have recovered from surgery and any required post-operative therapy. Specifically, participants must have an EGFR exon 19 deletion or L858R mutation.
  • Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo.

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