Clinical trial · Observational
Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network
NCT01574300CI-TRIAL-00042701CASTLEterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): interim assessment by sponsor
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer Metastatic | Lung Non-Small Cell Carcinoma | PROBABILISTIC | 0.70 |
| Small Cell Lung Carcinoma | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| therapeutic interventions | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Biospecimens and biofluids
- description
- This is a multi-cohort parallel study in which tumor, plasma and serum samples will be collected prior to the start of any therapeutic intervention for stage IV lung cancer. These biospecimens will be correlated with treatment and clinical data and distributed for peer reviewed research purposes to academic and community centers in the U.S. and Europe. The biospecimens collected in CASTLE will be analyzed for a panel of biomarkers, currently including: * tumor: epidermal growth factor receptor (EGFR), KRAS (Kirsten RAt Sarcoma) gene and EML4-ALK (echinoderm microtubule-associated protein-like 4 - anaplastic lymphoma kinase) translocations, and EGFR, TS (thymidylate synthase), ERCC1 (excision repair cross-complementing 1) and RRM1 (Ribonucleotide Reductase, M1 Subunit) gene expressions * serum: proteomics predictive for EGFR-TKI (tyrosine kinase inhibotors)response
- interventionNames
- Other: therapeutic interventions
Primary outcomes (1)
- measure
- Collect, process, store, and distribute for peer-reviewed research studies tumor-related and normal biospecimens from advanced stage lung cancer patients
- timeFrame
- 7 years
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.