NCT00596648

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Exelixis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	XL184	Capsules administered orally daily
DRUG	erlotinib	Tablets administered orally daily.

Timeline

• Start date: 2008-02-12
• Primary completion: 2012-08-02
• Completion: 2012-08-02
• First posted: 2008-01-17
• Last updated: 2026-01-13
• Results posted: 2026-01-13

Locations

13 sites across 1 country: United States