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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT01465802

NCT01465802
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with advanced non-small cell lung cancer (NSCLC).
  • For Groups 1 and 2: You have already tried at least one standard chemotherapy treatment for your advanced NSCLC, and it either stopped working or you had to stop due to side effects (you must have completed at least two cycles of that treatment).
  • For Group 3: You have not yet received any systemic (whole-body) treatment for your advanced NSCLC, and your cancer has a specific genetic change known as an EGFR mutation, HER-2 mutation, or HER-2 amplification — you may also have had chemotherapy or combined chemotherapy and radiation for an earlier stage of the disease, as long as it finished more than 12 months before joining.
  • You have signs of the disease present, though it does not need to be measurable on scans.
  • You are reasonably active and able to care for yourself (confirm with trial site what this means for your situation).
  • Your kidneys are working at an acceptable level (confirm with trial site).

Who may not be able to join:

  • You have previously been treated with a drug that targets EGFR or HER receptors.
  • You have had chemotherapy, radiation, biological therapy, or experimental treatments within the past 2 weeks.
  • You have a condition called diffuse interstitial lung disease (a type of widespread lung scarring or inflammation).
  • For Groups 1 and 2: Your only prior treatment for advanced NSCLC was an experimental therapy, with no approved chemotherapy ever received.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Pfizer
Registry
clinicaltrials_gov
Start date
26 December 2011
Est. completion
18 May 2015

Where this trial is recruiting

🇰🇷 South Korea 🇺🇸 United States

Primary endpoints

Percentage of Participants With Select Dermatologic Adverse Events of Interest (SDAEI) (All Causality, All Grade) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I; Percentage of Participants With SDAEI (All Causality, Grade Greater Than or Equal to [≥] 2) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I; Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I; Percentage of Participants With Diarrhea AEs (All Causality, All Grade and Grade ≥2) in the First 8...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov