Erlotinib Hydrochloride and Cabozantinib-s-Malate Alone or in Combination as Second or Third Line Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer

Conditions

• Recurrent Lung 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

• Cabozantinib S-malate — DRUG
  Given PO
• Erlotinib Hydrochloride — DRUG
  Given PO
• Laboratory Biomarker Analysis — OTHER
  Correlative studies

Study Details

This randomized phase II trial studies how well giving erlotinib hydrochloride and cabozantinib-s-malate alone or in combination works as second or third line therapy in treating patient with stage IV non-small cell lung cancer. Erlotinib hydrochloride and cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving erlotinib hydrochloride together with cabozantinib-s-malate is more effective than erlotinib hydrochloride or cabozantinib-s-malate alone in treating non-small cell lung cancer.

Key Dates

Start date

Feb 13, 2013

Status verified

Mar 2026

Primary completion

Aug 14, 2015

Completion

Mar 31, 2027

Study Design

Enrollment

125 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (erlotinib)
  Patients receive erlotinib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm B (cabozantinib)
  Patients receive cabozantinib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm C (erlotinib+cabozantinib)
  Patients receive erlotinib as patients in Arm A and cabozantinib as patients in Arm B. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm Z (erlotinib+cabozantinib; step II)
  Patients achieving disease progression in Arm A or Arm B may receive erlotinib and cabozantinib as patients in Arm C. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years ]

Locations (356)

Find similar trials in Scottsdale, AZ

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