Study on Erlotinib and Cabozantinib Alone or Together for Stage IV Non-small Cell Lung Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT01708954

This clinical trial is testing whether the drugs erlotinib and cabozantinib, used alone or together, can help treat patients with stage IV non-small cell lung cancer who have already tried other treatments.

Patient Parameters

Program Overview

This study is exploring how well the drugs erlotinib and cabozantinib work, either alone or in combination, as a second or third treatment option for patients with stage IV non-small cell lung cancer. These drugs may help stop cancer cells from growing by blocking certain enzymes. The study aims to find out if using both drugs together is more effective than using each one separately.

Description

The main goals of this study are to compare how long patients live without their cancer getting worse when treated with erlotinib alone, cabozantinib alone, or both drugs together. Researchers will also look at overall survival rates, how well the cancer responds to treatment, and any side effects from the treatments. Additionally, the study will investigate biological markers that might predict how well patients respond to the therapy.

Participants will be randomly assigned to one of three groups:

  • Group A (Erlotinib): Patients take erlotinib by mouth every day for 28 days. This cycle repeats as long as the cancer does not progress and side effects are manageable.
  • Group B (Cabozantinib): Patients take cabozantinib by mouth every day for 28 days. This cycle repeats as long as the cancer does not progress and side effects are manageable.
  • Group C (Erlotinib + Cabozantinib): Patients take both erlotinib and cabozantinib as described in Groups A and B. This cycle repeats as long as the cancer does not progress and side effects are manageable.

If the cancer progresses in Groups A or B, patients may switch to the combination treatment in Group C.

After finishing the study treatment, patients will have follow-up visits every 3 months for 2 years, then every 6 months for 3 years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage IV non-small cell lung cancer (NSCLC) with non-squamous histology.
  • Cancer must be measurable by scans.
  • Must have previously received one or two lines of chemotherapy.
  • Must have enough cancer tissue available for testing.
  • Must have good overall health with an ECOG performance status of 0-2.
  • Must have a life expectancy of more than 3 months.
  • Must have acceptable blood, kidney, and liver function.
  • Must be able to swallow tablets.
  • Must meet additional criteria if cancer progresses after initial treatment.

Exclusion Criteria

  • Lack of enough cancer tissue for testing.
  • Previous treatment with erlotinib, cabozantinib, or similar drugs.
  • Recent radiation therapy to certain areas.
  • History of significant bleeding or blood clots.
  • Current use of certain medications that affect blood clotting or liver enzymes.
  • Heart problems or uncontrolled high blood pressure.
  • Gastrointestinal issues that increase risk of complications.
  • Recent or active other cancers.
  • Pregnant or breastfeeding women.
  • HIV-positive patients on antiretroviral therapy.
  • Active hepatitis B infection.
  • Additional criteria if cancer progresses after initial treatment.

Locations

FACILITYZIPCITYSTATE
Mayo Clinic in Arizona85259ScottsdaleArizona
Memorial Medical Center95355ModestoCalifornia
Community Hospital of Monterey Peninsula93940MontereyCalifornia
Stanford Cancer Institute Palo Alto94304Palo AltoCalifornia
VA Palo Alto Health Care System94304Palo AltoCalifornia
Eisenhower Medical Center92270Rancho MirageCalifornia
The Medical Center of Aurora80012AuroraColorado
Boulder Community Foothills Hospital80303BoulderColorado
Rocky Mountain Cancer Centers-Boulder80304BoulderColorado
Penrose-Saint Francis Healthcare80907Colorado SpringsColorado

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