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NCT00949650 · ClinicalTrials.gov registry record · Phase 3

BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation

A Phase 3 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
345
Enrollment target

NCT00949650 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 345 participants.

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The verdict

NCT00949650, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
345 participants
Enrollment target

Study Summary

This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients.

Interventions

  • DRUG Cisplatin
  • DRUG Pemetrexed
  • DRUG BIBW 2992

Trial Details

FieldValue
Enrollment Target 345 participants
Start Date 2009-08-14
Est. Completion 2017-03-16
Phase Phase 3

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT00949650

The ClinicalTrials.gov registry entry for NCT00949650 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 345 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.

NCT00949650 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00949650 about?

NCT00949650 is a clinical study titled "BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation". This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplat...

What is the current status of trial NCT00949650?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 345 participants. The study started on 2009-08-14. Estimated completion is 2017-03-16.

What interventions are being tested in trial NCT00949650?

The interventions under investigation include: Cisplatin (DRUG), Pemetrexed (DRUG), BIBW 2992 (DRUG).

Who is sponsoring clinical trial NCT00949650?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.