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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)

Description

This is a prospective, randomized Phase III trial comparing personalized adjuvant therapy with erlotinib versus placebo in completely resected NSCLC stage IB (tumors 4 cm)-IIIA (excluding N3 disease and T1aN0M0) patients with EGFR mutation. Primary Objective: Primary objective is to determine whether adjuvant therapy with erlotinib will result in improved overall survival (OS) over placebo for patients with completely resected stage IB-IIIA patients with EGFR mutation. We hypothesize that personalized adjuvant therapy would significantly improve the overall survival in patients with resected NSCLC both for those where post-operative chemotherapy is generally not recommended and for patients after treatment with platinum based chemotherapy. Study Population: Participants, 18 years or older previously treated to A151216 with a result of EGFR exon 19 deletion or L848R mutation; Completely resected NSCLC with negative margins; complete recovery from surgery; no interstitial and fibrosis or lung disease. Study Arms: Arm 1: Treat with erlotinib at 150 mg orally once daily for up to 2 years or until disease progression or excessive toxicity. One cycle = 21 days. Arm 2: Treat with placebo at 150 mg orally once daily for up to 2 years or until disease progression or excessive toxicity. One cycle = 21 days. Follow-up: Follow-up every 6 months for 5 years following randomization. Once a patient progresses follow only for survival every 6 months. Primary endpoint: To assess whether completely resected NSCLC stage IB-IIIA patients with an EGFR mutation treated with erlotinib following complete resection have longer overall survival (OS) than patients treated with placebo alone. Analysis: The final analysis will take place once 183 deaths are observed. All analyses will be based on the intention to treat principle, and will include all randomized patients, except patients who withdraw consent prior to receiving treatment.

Phase

Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.

Inclusion and Exclusion Criteria

  • 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 with known resistant mutations in the EGFR tyrosine-kinase (TK) domain (T790M) are not eligible - 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 - No prior or concurrent malignancies within 5 years, except non-melanoma skin carcinoma and in situ carcinomas - Non-pregnant and non-lactating - No history of cornea abnormalities - Granulocytes >= 1,500/ul - Platelets >= 100,000/ul - Total bilirubin =< 1.5 x upper limit of normal (ULN) - Serum glutamic oxaloacetic transaminase (SGOT) =< 1.5 x ULN - Serum creatinine =< 1.5 x ULN

Sites

Please contact Carryl Du Bois to learn more about where you can participate in this trial. Please use the contact form on the right side.

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