CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 125 enrolled / 125 target
Drug / intervention
Cabozantinib S-malate +2 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/NCT01708954
NCT01708954Phase 2ActiveUpdate Overdue (0.8/mo)Completion was 130mo ago

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

National Cancer Institute (NCI)·interventional·Posted Oct 17, 2012·Updated Jun 15, 2026

In Brief

A Phase 2 clinical trial evaluating Cabozantinib S-malate, Erlotinib Hydrochloride, and 1 other intervention for Recurrent Lung Non-Small Cell Carcinoma and Stage IV Lung Non-Small Cell Cancer AJCC v7. Active but no longer recruiting, targeting 125 participants across 356 sites.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2Active
201320142015201620172018201920202021202220232024202520262027
First PostedOct 17, 2012
Enrollment StartFeb 13, 2013
Primary CompletionAug 14, 2015
Study CompletionMar 31, 2027
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 13.7 years ago

Arms & Interventions

Arm A (erlotinib)experimental

Patients receive erlotinib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Erlotinib HydrochlorideOther: Laboratory Biomarker Analysis
Arm B (cabozantinib)experimental

Patients receive cabozantinib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Cabozantinib S-malateOther: Laboratory Biomarker Analysis
Arm C (erlotinib+cabozantinib)experimental

Patients receive erlotinib as patients in Arm A and cabozantinib as patients in Arm B. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Cabozantinib S-malateDrug: Erlotinib HydrochlorideOther: Laboratory Biomarker Analysis
Arm Z (erlotinib+cabozantinib; step II)experimental

Patients achieving disease progression in Arm A or Arm B may receive erlotinib and cabozantinib as patients in Arm C. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Cabozantinib S-malateDrug: Erlotinib HydrochlorideOther: Laboratory Biomarker Analysis

Interventions

Cabozantinib S-malatedrug

Given PO

Erlotinib Hydrochloridedrug

Given PO

Laboratory Biomarker Analysisother

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