This trial is active, not recruiting.

Condition lung cancer
Treatment obtain tissue specimens
Sponsor Memorial Sloan Kettering Cancer Center
Start date February 2011
End date February 2017
Trial size 30 participants
Trial identifier NCT01300429, 11-014


The purpose of this study is to try to learn more about how small molecule kinase inhibitor medications work in treating lung cancer. Crizotinib (PF-02341066) is a drug that has been shown to shrink tumors in some patients with lung cancer. While the investigators know how this drug works to stop the growth of tumors that depend on change in the gene named ALK (also called EML4-ALK), the investigators do not know why the drug stops working. The investigators would like to examine the tumor to help us better understand why crizotinib has stopped working as well as it once did. The tumor will be examined with multiple tests to look for the reason that crizotinib stopped working.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
This is a protocol to obtain and/or analyze tissue specimens of patients with NSCLC harboring an activating ALK inversion or translocation that have had a previous clinical response to tyrosine kinase inhibitor therapy and subsequently experience progressive disease. The tissue will be used to identify changes in the ALK gene that are acquired during treatment with an ALK TKI and may account for acquired resistance.
obtain tissue specimens
One core biopsy specimen will be placed in formalin and processed for cytogenetic and FISH analyses as well as DNA for ALK sequencing. The second core biopsy specimen will be immediately frozen in liquid nitrogen and stored in a -80 degree freezer for research specimen. Collection will be performed on-site at the time of the procedure.

Primary Outcomes

the frequency of acquired mutations
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - ≥18 years of age - Histologically proven diagnosis of NSCLC at MSKCC Tumor positive for a translocation or inversion event involving the ALK gene locus - Clinical response to treatment with crizotinib as defined by either: Radiographic partial or complete response defined by RECIST or WHO OR: Radiographic stable disease for at least 8 weeks - Radiographic progression of disease amenable to biopsy while on treatment with crizotinib as defined by RECIST or WHO - Signed informed consent Exclusion Criteria: - Deemed by their treating physician to be medically unfit for biopsy - Women who are pregnant or breast-feeding

Additional Information

Official title Molecular Determinants of Acquired Clinical Resistance to Crizotinib in Non-small Cell Lung Cancer Harboring a Translocation or Inversion Event Involving the ALK Gene Locus
Principal investigator Gregory Riely, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.