Key Questions:

How should the development of new therapeutic interventions be stimulated and    accelerated for patients with locally advanced NSCLC?

What is currently known and what is being learned about the biology of NSCLC for    clinical trial development and design?

In order to fully explore novel interventions, what new diagnostic or therapeutic tools    will be required to address the issues and speed development?

Outcomes and Discussion Points:

To continue to work toward the optimization of currently available therapies, with an    emphasis on optimizing therapy for individual patients/special patient subsets. To    focus on the incorporation of correlative studies into clinical trial design and    integration of novel therapeutic agents directed against newly defined molecular    targets.

Multiple pathways are potential targets in NSCLC. Trials studying combinations of    conventional therapy and novel targeted therapy against these pathways should be    conducted.

Radiotherapy outcomes may be improved by investigating the roles of various    aspects of the physical, molecular, and physiological targeting of the tumor to    overcome mechanisms of resistance.

The final goal in the development of tumor-specific imaging agents should be the    production of noninvasive tumor profiles to provide diagnostic, therapeutic, and    prognostic information.

Phase III proposals with antiangiogenic agents should require safety and feasibility    data from Phase II studies, as well as Phase II studies testing toxicity and efficacy.

Trial design strategies and intermediate end points for gene therapy, immunotherapy,    and biologics need to be developed and implemented.

Key Recommendations:

Phase II studies continue to yield valuable information and should continue to be a    component of testing new agents.

New agents will more than likely achieve their maximal benefit as a component of    combination therapy or as "chemopreventatives."

Potential targets for new molecularly-directed therapies need to be defined.

Surrogate markers or other models may be required for mechanistic research    purposes due to the logistic difficulties in obtaining serial lung biopsies from patients    with NSCLC.