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CompletedPhase 1 / Phase 2NCT00596648
Official study title

A Study of XL184 (Cabozantinib) With or Without Erlotinib in Subjects With Non-Small Cell Lung Cancer (NSCLC)

Study summary

The study consisted of a Phase 1 dose escalation/dose de-escalation portion to determine a safe and tolerable combination dose(s) of cabozantinib and erlotinib, and a Phase 2 Simon optimal 2-stage design portion with randomized assignment of subjects in an equal ratio to determine the objective response rate (ORR) of cabozantinib with or without erlotinib in subjects with non-small cell lung cancer (NSCLC) who have progressed after responding to treatment with erlotinib. The doses of cabozantinib used in this study were based on the salt weight, not the freebase weight.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedXL184 and erlotinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 13, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?13 U.S. locations

Locations may change over time.

Who runs it?Exelixis

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Exelixis
Interventions being studied
Drug: XL184; Drug: erlotinib
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)→
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
  • Phase 1:
  • Subjects had pathologically confirmed NSCLC and currently have Stage IIIb or IV NSCLC
  • Subjects had failed treatment with erlotinib at 150 mg qd
  • Subjects had tolerated erlotinib at the dose of the cohort in which they were enrolled (or at a higher dose) for at least 6 weeks (or for the duration of treatment if disease progression had occurred during treatment with erlotinib for less than 6 weeks)
  • The subject was at least 18 years old
  • The subject had an ECOG performance status of \< 2
  • The subject had organ and marrow function as follows: - absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL, bilirubin ≤ 1.5 times the upper limit of normal, serum creatinine ≤ 1.5 mg/dL or if serum creatinine \> 1.5 mg/dL calculated creatinine clearance ≥ 60 mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal, amylase and lipase \< 1.5 times the upper limit of normal
  • Sexually active subjects had to agree to use medically accepted methods of contraception during the course of the study and for 3 months following discontinuation of study treatments (excluding women who are not of child bearing potential and men who have been sterilized)
  • Female subjects of childbearing potential had to have a negative pregnancy test at enrollment. Females of childbearing potential were defined as sexually mature women without prior hysterectomy or who had evidence of menses in the past 12 months. However, women who had been amenorrheic for 12 or more months were still considered to be of childbearing potential if the amenorrhea was possibly due to prior chemotherapy, antiestrogens, or ovarian suppression
  • The subject had no other diagnosis of malignancy (unless non-melanoma skin cancer, carcinoma in situ of the cervix, or a malignancy diagnosed ≥ 2 years previously, and currently with no evidence of disease)
Reasons someone may not be able to joinExclusion criteria
  • Phase 1:
  • The subject had received anti-cancer treatment (eg, chemotherapy, radiotherapy, cytokines, or hormones) within 4 weeks with exception of erlotinib (6 weeks for nitrosoureas or mitomycin C) before the first dose of study drug
  • The subject had not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤1 from clinically significant adverse events (AEs) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study enrollment
  • The subject had symptomatic or uncontrolled brain metastases requiring current treatment, including steroids and anticonvulsants
  • The subject had a history of clinically significant hematemesis or a recent history of hemoptysis of \> 0.5 teaspoon of red blood or other signs indicative of pulmonary hemorrhage
  • The subject had the presence of cavitation, endobronchial lesion or a lesion abutting a major blood vessel
  • The subject had serious intercurrent illness, such as uncontrolled hypertension (sustained blood pressure \[BP\] readings of \> 140 mmHg systolic or \> 90 mmHg diastolic not controlled with anti-hypertensive medication), unhealed wounds from recent surgery or clinically significant cardiac arrhythmias or a recent history of significant disease such as either symptomatic congestive heart failure or unstable angina pectoris within 3 months or myocardial infarction within 6 months before the first dose of study drug
  • The subject was pregnant or breastfeeding
  • The subject had an active infection requiring systemic treatment
  • The subject had an allergy or hypersensitivity to components of either the cabozantinib or erlotinib formulations
  • The subject was incapable of understanding and complying with the protocol or unable to provide informed consent Inclusion Criteria-Phase 2
  • Subjects had pathologically confirmed NSCLC and currently have Stage IIIb or IV NSCLC
  • Subjects had: Documented radiological PD, following a prior response, per investigator assessment, to monotherapy with erlotinib, OR; Documented radiological PD, per investigator assessment, following stable disease of at least 6 months on monotherapy with erlotinib
  • Subjects who had received subsequent anti-cancer therapy after having progressed on erlotinib (as defined above) also had to have documented radiological PD per investigator assessment to their most recent anti-cancer therapy. If the most recent anti-cancer therapy was erlotinib after having previously progressed on erlotinib (as defined above) the subject also had to have documented radiological PD per investigator assessment to their most recent course of erlotinib
  • Subjects had to have tolerated erlotinib at the maximal dose that would be administered in Phase 2 (or at a higher dose) for a minimum of 6 weeks
  • Subjects had measurable disease per RECIST
  • Subjects had to have 15 unstained consecutive slides of archival or fresh tumor tissue (from one tumor block, frozen tumor tissue, or a paraffin block) identified and designated for shipment to the sponsor if permitted by local regulations (including IRB \[Institutional Review Board\] policies). The eligibility of subjects with \< 15 unstained slides of available archival tissue was discussed with the sponsor
  • The subject was at least 18 years old
  • The subject had an ECOG performance status of \< 1
  • The subject had organ and marrow function as follows: absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL, bilirubin ≤ 1.5 times the upper limit of normal, serum creatinine ≤ 1.5 mg/dL or if serum creatinine \> 1.5 mg/dL calculated creatinine clearance ≥ 60 mL/min, ALT and AST ≤ 2.5 times the upper limit of normal, amylase and lipase \< 1.5 times the upper limit of normal
  • Sexually active subjects had to agree to use medically accepted methods of contraception during the course of the study and for 3 months following discontinuation of study treatments (excluding women who are not of child bearing potential and men who have been sterilized)
  • Female subjects of childbearing potential had to have a negative pregnancy test at enrollment. Females of childbearing potential were defined as sexually mature women without prior hysterectomy or who had evidence of menses in the past 12 months. However, women who had been amenorrheic for 12 or more months were still considered to be of childbearing potential if the amenorrhea was possibly due to prior chemotherapy, antiestrogens, or ovarian suppression
  • The subject had no other diagnosis of malignancy (unless non-melanoma skin cancer, carcinoma in situ of the cervix, or a malignancy diagnosed ≥ 2 years previously, and currently with no evidence of disease)

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

  • Katmai Oncology GroupAnchorage, Alaska
  • Stanford University Medical CenterPalo Alto, California
  • University of California, DavisSacramento, California
  • Yale University School of MedicineNew Haven, Connecticut
  • Georgetown University/Lombardi Comprehensive Cancer CenterWashington D.C., District of Columbia
  • University of Chicago Medical CenterChicago, Illinois
  • Dana Farber Cancer InstituteBoston, Massachusetts
  • Park Nicollet InstituteSaint Louis Park, Minnesota
  • Summit Medical GroupBerkeley Heights, New Jersey
  • Case Western Reserve UniversityCleveland, Ohio
  • MD Anderson Cancer CenterHouston, Texas
  • Swedish Cancer InstituteSeattle, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 13, 2026. Always confirm current availability with the study team.

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