interim assessment by sponsor

The purpose of this study is to facilitate application of the known biomarkers to patients presenting today, and to establish a collection of biospecimens that will be useful for discovering and validating new biomarkers for future use.

Because of the historically poor outcomes of lung cancer patients, suboptimal therapeutic efficacy, and significant side effects of chemotherapy, and the need to choose more efficacious treatment regimens, and patients most likely to benefit from them, there is a need to predict a priori whether an individual patient's tumor will respond to a particular therapeutic agent. However, virtually all lung cancer tumor samples available today are from resection specimens so direct, intra-patient molecular-clinical therapy correlations are impossible.

Without the critical mass of tissue and data necessary to identify optimal molecular targets for lung cancer and drugs active against these targets, new discoveries that offer the only hope of long-term survival for many lung cancer patients remain elusive.

This study facilitates the collection of biospecimens from advanced lung cancer patients and routine determination of a panel of documented clinically significant biomarkers. In addition, it will centrally integrate and standardize research tissue samples with corresponding proteomic, genomic, molecular and clinical data across a multitude of institutions and oncology networks

Inclusion Criteria:

• M1A or B NSCLC with any number of prior therapies or any stage Small cell Lung Cancer (SCLC) with any number of prior therapies
• Planned systemic therapy (i.e. intent to treat)
• Provision of written informed consent for biospecimen storage, broad genetic and proteomic analysis of tumor and normal tissues, without restrictions, AND correlation with outcome data
• Aged 18 years and over.
• Measurable or evaluable disease.
• ECOG performance status of 0-2 with expected survival of at least 3 months.
• Tumor specimens:
• Tumor specimens:
• 4.7.1 First Priority: availability of a minimum of a 1 X 10 mm core fresh frozen tumor, or ≥3 mm diameter spherical pellet from a pleural effusion (≥50% tumor cells), or ≥3 mm diameter spherical pellet from a fine needle aspirate (≥50% tumor cells) from clinically indicated interventional procedures, with no systemic anti-cancer therapy or radiation to all sites of evaluable disease between collection of the biopsy and entry into the study (e.g. if a brain metastasis was radiated but the lung tumor was not, then the latter could still be biopsied and the subject enrolled after radiation therapy of the brain metastasis (and vice versa)).

or

• Second Priority: availability of paraffin-embedded tumor (via biopsies or pleural effusions) at least 5 X 5 mm (3 X 3 mm for pleural effusions) cross-sectional tumor area, with no systemic anti-cancer therapy or radiation to all sites of evaluable disease between collection of the biopsy and entry into the study; the collection of the paraffin-embedded tissues may have taken place up to 12 months prior to enrollment in CASTLE.
• Willingness to undergo all study collection procedures and sample analyses including prerequisite baseline molecular testing via ResponseDX: Lung (Response Genetics Inc.) and VeriStrat (Biodesix) - see 6.3 below for details.
• Exclusion criteria
• Other co-existing malignancies except for basal cell carcinoma or cervical cancer in situ.
• Compromise of patient diagnosis or staging if tissue is harvested for research

Advanced stage lung cancer patients