Details

Details

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

IRB A081105

CC 14-1418

Hospital Fairview, Florida Weston, Hillcrest, Main Campus, Mansfield, North Coast Cancer, South Pointe, Strongsville, Wooster

Stage Stage 2, Stage 3

Disease Lung - NSCLC (Non-small cell lung cancer)

Drug Erlotinib

Description

Description

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.
Secondary Objectives
  • 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.
  • To evaluate the safety profile of erlotinib in the adjuvant setting.
  • 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.
  • To assess the primary and secondary objectives in all randomized patients, regardless of central confirmation of the EGFR mutant status.
Inclusion Criteria

Inclusion Criteria

  1. 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 protocolspecified laboratory.
    • By a local 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 with known resistant mutations in the EGFR TK domain (T790M) are not eligible.
    • Patients that are both EGFR mutant and ALK rearrangements will be registered to A081105.
  2. Completely resected stage IB (≥4 cm), II or IIIA non-squamous NSCLC with negative margins. Patients may not have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancer.
  3. 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, 180 days if adjuvant chemotherapy was administered, and 240 days if adjuvant chemotherapy and radiation therapy was administered.
  4. No interstitial fibrosis or lung disease.
  5. Age ≥18 years.
  6. ECOG Performance Status 0-1.
  7. No locally advanced or metastatic cancer requiring systemic therapy within 5 years prior to registration. No secondary primary lung cancer diagnosed concurrently or within 2 years prior to registration.
  8. Non-pregnant and non-lactating.
  9. Required Initial Laboratory Values
    • Granulocytes ≥ 1,500/μl
    • Platelets ≥ 100,000/μl
    • Total bilirubin ≤1.5 x ULN
    • SGOT ≤ 1.5 x ULN
    • Serum Creatinine ≤ 1.5 x ULN
Exclusion Criteria

Exclusion Criteria

Exclusion Criteria Not Available