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 (NCT01708954)
A Randomized Phase II Trial of Erlotinib, Cabozantinib, or Erlotinib Plus Cabozantinib as 2nd or 3rd Line Therapy in Patients With EGFR Wild-Type NSCLC
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (23 items) and avoid the listed exclusions (28 items).
Location: Mayo Clinic in Arizona — Scottsdale, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- EXCLUSION CRITERIA STEP 1:
- Patients without sufficient pathology material representative of the patient's cancer (tumor block or 10 unstained slides)
- Prior erlotinib, other EGFR tyrosine kinase inhibitor therapy, vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor therapy, Met tyrosine kinase inhibitor therapy, or Met monoclonal antibody (MetMAb); prior antibody therapy such as bevacizumab or cetuximab is allowed with a washout period depending on dosing interval and investigational nature
- Prior radiation therapy to the thoracic cavity, abdomen, or pelvis within 3 months prior to registration, to bone or brain metastasis within 14 days prior to registration, or to any other site within 28 days prior to registration
- History of the following: Clinically-significant gastrointestinal (GI) bleeding within 6 months prior to registration; Hemoptysis of \>= 0.5 teaspoon (2.5 mL) of red blood within 3 months prior to registration; Any other signs indicative of pulmonary hemorrhage within 3 months prior to registration
- Radiographic or other evidence of the following within 28 days prior to registration: • Tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor; Cavitating pulmonary lesion(s); Tumor in contact with, invading or encasing any major blood vessels
- Psychiatric illness/social situations that would limit compliance with study requirements
- History of major thrombotic events (deep vein thrombosis \[DVT\] or pulmonary embolism \[PE\]) within 6 months prior to registration
- Concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, low molecular weight heparin (LMWH), thrombin or Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel). (low dose aspirin \[=\< 81 mg/day\] and prophylactic LMWH are permitted)
- Concomitant treatment of strong cytochrome P450 3A4 (CYP3A4) inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's wort)
- Cardiovascular disorders including: Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening;
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (356 Sites)
Showing the first 25 of 356 sites.
- Mayo Clinic in Arizona — Scottsdale, Arizona
- Memorial Medical Center — Modesto, California
- Community Hospital of Monterey Peninsula — Monterey, California
- Stanford Cancer Institute Palo Alto — Palo Alto, California
- VA Palo Alto Health Care System — Palo Alto, California
- Eisenhower Medical Center — Rancho Mirage, California
- The Medical Center of Aurora — Aurora, Colorado
- Boulder Community Foothills Hospital — Boulder, Colorado
- Rocky Mountain Cancer Centers-Boulder — Boulder, Colorado
- Penrose-Saint Francis Healthcare — Colorado Springs, Colorado
- Rocky Mountain Cancer Centers-Penrose — Colorado Springs, Colorado
- AdventHealth Porter — Denver, Colorado
- Colorado Blood Cancer Institute — Denver, Colorado
- Presbyterian - Saint Lukes Medical Center - Health One — Denver, Colorado
- Rocky Mountain Cancer Centers-Midtown — Denver, Colorado
- Saint Joseph Hospital - Cancer Centers of Colorado — Denver, Colorado
- Rocky Mountain Cancer Centers-Rose — Denver, Colorado
- Rose Medical Center — Denver, Colorado
- Western States Cancer Research NCORP — Denver, Colorado
- Mercy Medical Center — Durango, Colorado
- Mountain Blue Cancer Care Center - Swedish — Englewood, Colorado
- Swedish Medical Center — Englewood, Colorado
- Mountain Blue Cancer Care Center — Golden, Colorado
- Banner North Colorado Medical Center — Greeley, Colorado
- Rocky Mountain Cancer Centers-Greenwood Village — Greenwood Village, Colorado
📞 Contact the Study Coordinator
Phone: (800) 664-4580
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Recurrent Lung Non-Small Cell Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.