Erlotinib Hydrochloride With or Without Bevacizumab in Treating Patients With Stage IV Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations

Conditions

• EGFR Exon 19 Deletion Mutation
• EGFR NP_005219.2:p.L858R
• Lung Non-Squamous Non-Small Cell Carcinoma
• Stage IV Lung Non-Small Cell Cancer AJCC v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Erlotinib — DRUG
  Given PO
• Erlotinib Hydrochloride — DRUG
  Given PO
• Laboratory Biomarker Analysis — OTHER
  Correlative studies

Study Details

This randomized phase II trial studies how well erlotinib hydrochloride (Tarceva) with or without bevacizumab (Avastin) works in treating patients with stage IV non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. Bevacizumab may also stop the growth of NSCLC by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether erlotinib hydrochloride is more effective when given alone or with bevacizumab in treating patients with NSCLC.

Key Dates

First listed

Feb 14, 2012

Start date

Mar 16, 2012

Status verified

Jul 2020

Primary completion

Feb 13, 2018

Completion

Aug 18, 2020

Study Design

Enrollment

88 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A (erlotinib hydrochloride)
  Patients receive erlotinib hydrochloride PO QD on days 1-21. (erlotinib will no longer be supplied and all patients will be removed from study treatment. No further follow-up by any study participants as of September 1, 2019)
• Experimental: Arm B (erlotinib hydrochloride, bevacizumab)
  Patients receive erlotinib hydrochloride as in Arm A and bevacizumab IV over 30-90 minutes on day 1. (erlotinib will no longer be supplied and all patients will be removed from study treatment. No further follow-up by any study participants as of September 1, 2019)

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Time from randomization to disease progression and death of any cause, whichever comes first, assessed up to 6 years ]

Locations (19)

Find similar trials in La Jolla, CA

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