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NCT01248247 · ClinicalTrials.gov registry record · Phase 2

BATTLE-2 Program: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
334
Enrollment target

NCT01248247: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT01248247 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 334 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (151% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01248247, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
334 participants
Enrollment target

Study Summary

Different people have different biomarkers (chemical "markers" in the blood that may be related to your reaction to study drugs). If researchers know about your biomarkers before you receive treatment, they may be able to prescribe a treatment that is better suited to your body's specific needs. The goal of this clinical research study is to learn if drug or drug combinations based on your biomarkers can help to control NSCLC. The safety of these drug combinations will also be studied.

Primary Outcome

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Interventions

  • DRUG Sorafenib
  • DRUG Erlotinib
  • DRUG AZD6244
  • DRUG MK-2206

Trial Details

FieldValue
Enrollment Target 334 participants
Start Date 2011-06-02
Est. Completion 2020-11-30
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT01248247 record still lists

NCT01248247 is an interventional study that assigns participants to a tested intervention. The registered 334 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (151% higher).

The record links to 0 conditions, and to 4 interventions - of which Sorafenib is the first listed.

NCT01248247 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01248247 about?

NCT01248247 is a clinical study titled "BATTLE-2 Program: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer". Different people have different biomarkers (chemical "markers" in the blood that may be related to your reaction to study drugs). If researchers know about your biomarkers before you receive treatment, they may be able to prescribe a treatment that is better suited to your body's specific needs. Th...

What is the current status of trial NCT01248247?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 334 participants. The study started on 2011-06-02. Estimated completion is 2020-11-30.

What interventions are being tested in trial NCT01248247?

The interventions under investigation include: Sorafenib (DRUG), Erlotinib (DRUG), AZD6244 (DRUG), MK-2206 (DRUG).

Who is sponsoring clinical trial NCT01248247?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01248247's enrollment target sits among peer trials

334 143rd of 2000 higher than 1,857 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01248247, the US trial registry maintained by the National Library of Medicine. NCT01248247 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.