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Active Not RecruitingPhase 2NCT01708954
Official study title

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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCabozantinib S-malate and Erlotinib Hydrochloride

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 1, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 2

Interventional

Where is it offered?356 U.S. locations

Locations may change over time.

Who runs it?National Cancer Institute (NCI)

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
National Cancer Institute (NCI)
Interventions being studied
Drug: Cabozantinib S-malate; Drug: Erlotinib Hydrochloride; Other: Laboratory Biomarker Analysis
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→Recurrent or relapsed→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Criteria:
  • Tumor with a sensitizing mutation in epidermal growth factor receptor (EGFR), defined as follows:
  • EGFR mutation testing of tumor has been performed and did not demonstrate an EGFR tyrosine kinase inhibitor sensitizing mutation; at minimum, testing for EGFR exon 19 deletion and exon 21 L858R mutations must have been included; OR
  • EGFR mutation testing has been attempted and is inconclusive (for example, due to lack of sufficient deoxyribonucleic acid \[DNA\] yield); OR
  • EGFR mutation status is unknown but tumor is positive for at least one alternative driver mutation, i.e: Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation, v-raf murine sarcoma viral oncogene homolog B (BRAF) mutation, human epidermal growth factor receptor 2 (HER2) mutation, ret proto-oncogene (RET) rearrangement/fusion, or one not listed following approval by the study chair prior to registration
  • INCLUSION CRITERIA STEP 1:
  • Cytologically or histologically confirmed non-small cell lung carcinoma (NSCLC)
  • Predominant non-squamous histology (patients with NSCLC not otherwise specified \[NOS\] are eligible); mixed tumors will be categorized by the predominant cell type; if small cell elements are present the patient is ineligible
  • Stage IV disease (includes M1a, M1b, or recurrent disease), according to the 7th edition of the lung cancer TNM classification system
  • Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria; baseline measurements and evaluation of all sites of disease must be obtained within 4 weeks prior to registration
  • Prior to registration, the investigator/site must confirm that sufficient pathology material representative of patient's cancer is available for submission for MET immunohistochemical (IHC) testing
  • Patients must have received one or two lines of prior chemotherapy (first line platinum-doublet based chemotherapy plus switch maintenance chemotherapy counts as one line of therapy); prior adjuvant chemotherapy for early stage disease does not count as one line of therapy if 12 months or greater elapsed between completion of adjuvant therapy and initiation of first-line systemic therapy; if less than 12 months elapsed, adjuvant chemotherapy counts as one line of therapy
  • Any prior chemotherapy (based on administration schedule) must have been completed in greater than or equal to the time frames specified in the protocol
  • Patients must have discontinued treatment with any other type of investigational agent \>= 4 weeks prior to registration
  • Patients must have recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 =\< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
  • Patients with no known brain metastasis at baseline must have baseline brain imaging within 12 weeks prior to study registration not demonstrating brain metastases; patients with brain metastases at baseline must have baseline brain imagining within 4 weeks prior to study registration and meet all of the specific criteria for brain mets listed in the protocol
  • Radiation related toxicities must have resolved to =\< grade 1 prior to registration
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2
  • Patients must have an anticipated life expectancy greater than 3 months
  • Acceptable bone marrow, renal and hepatic function within 2 weeks prior to registration as defined in the protocol
  • Patients must have corrected QT interval calculated by the Fridericia formula (QTcF) =\< 500 ms within 28 days before registration
  • Patients must be able to swallow tablets
  • INCLUSION CRITERIA STEP 2:
  • Patients must have met all eligibility requirements for Step 1 at time of registration to Step 1 to be eligible for Step 2
  • Patients must have radiographic progressive disease per RECIST v1.1 criteria after \>= 2 courses of therapy on Arm A or Arm B
  • Patients must be registered to Step 2 within 4 weeks of the last dose of treatment administration from Step 1
  • Patients must have an ECOG performance status between 0-2
  • Patients must have recovered to baseline (pre-Step 1) or CTCAE version 4.0 \<= grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant AEs

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Mayo Clinic in ArizonaScottsdale, Arizona
  • Memorial Medical CenterModesto, California
  • Community Hospital of Monterey PeninsulaMonterey, California
  • Stanford Cancer Institute Palo AltoPalo Alto, California
  • VA Palo Alto Health Care SystemPalo Alto, California
  • Eisenhower Medical CenterRancho Mirage, California
  • The Medical Center of AuroraAurora, Colorado
  • Boulder Community Foothills HospitalBoulder, Colorado
  • Rocky Mountain Cancer Centers-BoulderBoulder, Colorado
  • Penrose-Saint Francis HealthcareColorado Springs, Colorado
  • Rocky Mountain Cancer Centers-PenroseColorado Springs, Colorado
  • AdventHealth PorterDenver, Colorado

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 1, 2026. Always confirm current availability with the study team.

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