CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 92 enrolled
Drug / intervention
XL184 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00596648
NCT00596648Phase 2Completed
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A Phase 1b/2 Study of XL184 With or Without Erlotinib in Subjects With Non-Small Cell Lung Cancer

Exelixis·interventional·Posted Jan 17, 2008·Updated Jan 13, 2026

In Brief

A Phase 2 clinical trial evaluating XL184 and erlotinib for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 92 participants across 13 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 17, 2008
Enrollment StartFeb 12, 2008
Primary CompletionAug 2, 2012
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 18.5 years ago

Interventions

XL184drug

Capsules administered orally daily

erlotinibdrug

Tablets administered orally daily.