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NCT01708954 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Recurrent Lung Non-Small Cell Carcinoma and Stage IV Lung Non-Small Cell Cancer AJCC v7, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
125
Enrollment target
20
Study locations

NCT01708954: Active Phase 2 study of Recurrent Lung Non-Small Cell Carcinoma and Stage IV Lung Non-Small Cell Cancer AJCC v7, sponsored by National Cancer Institute (NCI).

NCT01708954 is a Phase 2 study of Recurrent Lung Non-Small Cell Carcinoma and Stage IV Lung Non-Small Cell Cancer AJCC v7 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 125 participants, roughly in line with the 115-participant average among 30 other Recurrent Lung Non-Small Cell Carcinoma trials with a reported enrollment target. The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01708954, a Phase 2 study of Recurrent Lung Non-Small Cell Carcinoma and Stage IV Lung Non-Small Cell Cancer AJCC v7, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
125 participants
Enrollment target
20
Study locations

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.

Primary Outcome

PFS is defined as the time from randomization to documented disease progression or death from any cause, whichever occurred first. Patients who had not experienced an event of interest by the time of analysis were censored at the date of last disease assessment.

Interventions

  • DRUG Cabozantinib S-malate
  • OTHER Laboratory Biomarker Analysis
  • DRUG Erlotinib Hydrochloride

Study Locations (20)

Colorado

  • The Medical Center of Aurora - Aurora
  • Boulder Community Foothills Hospital - Boulder
  • Rocky Mountain Cancer Centers-Boulder - Boulder
  • Penrose-Saint Francis Healthcare - Colorado Springs
  • Rocky Mountain Cancer Centers-Penrose - Colorado Springs
  • AdventHealth Porter - Denver
  • Colorado Blood Cancer Institute - Denver
  • Presbyterian - Saint Lukes Medical Center - Health One - Denver
  • Rocky Mountain Cancer Centers-Midtown - Denver
  • Saint Joseph Hospital - Cancer Centers of Colorado - Denver
  • Rocky Mountain Cancer Centers-Rose - Denver
  • Rose Medical Center - Denver
  • Western States Cancer Research NCORP - Denver
  • Mercy Medical Center - Durango

California

  • Memorial Medical Center - Modesto
  • Community Hospital of Monterey Peninsula - Monterey
  • Stanford Cancer Institute Palo Alto - Palo Alto
  • VA Palo Alto Health Care System - Palo Alto
  • Eisenhower Medical Center - Rancho Mirage

Arizona

  • Mayo Clinic in Arizona - Scottsdale

Trial Details

FieldValue
Enrollment Target 125 participants
Start Date 2013-02-13
Est. Completion 2026-03-18
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT01708954 still lists

NCT01708954 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 115-participant average among 30 other Recurrent Lung Non-Small Cell Carcinoma trials with a reported enrollment target.

The record links to 2 conditions, with Recurrent Lung Non-Small Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Cabozantinib S-malate is the first listed.

NCT01708954 names 20 study sites across 3 states, led by Colorado, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT01708954 about?

NCT01708954 is a clinical study titled "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". 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 o...

What is the current status of trial NCT01708954?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2013-02-13. Estimated completion is 2026-03-18.

What conditions does trial NCT01708954 study?

This clinical trial studies the following conditions: Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Non-Small Cell Cancer AJCC v7.

What interventions are being tested in trial NCT01708954?

The interventions under investigation include: Cabozantinib S-malate (DRUG), Laboratory Biomarker Analysis (OTHER), Erlotinib Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT01708954?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01708954 being conducted?

This trial has 20 study locations across Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Recurrent Lung Non-Small Cell Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01708954's enrollment target sits among peer trials

125 8th of 30 higher than 23 of 30 other Recurrent Lung Non-Small Cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Recurrent Lung Non-Small Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01708954, the US trial registry maintained by the National Library of Medicine. NCT01708954 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.