NCT00528281 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Ramlau, R
, Thomas, M., Plummer, R., Reck, M., Heussel, C. P., Lau, M., Parikh, R., Kaneko, T., Oliva, C., Novello, S. Phase I study of lapatinib, a dual-tyrosine kinase inhibitor, and pemetrexed in the second-line treatment of advanced or metastatic non-small-cell lung cancer, J Clin Oncol 27, 2009 (suppl; abstr e19027)

A Single-arm, Two-stage Phase II Study of Lapatinib and Pemetrexed in the Second Line Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer

Clinical trial NCT00528281 - References