Biomarkers in Predicting Treatment Response in Samples From Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy

ConditionsStage IA Non-small Cell Lung Cancer Stage IB Non-small Cell Lung Cancer Stage IIA Non-small Cell Lung Cancer Stage IIB Non-small Cell Lung Cancer Stage IIIA Non-small Cell Lung Cancer

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorNational Cancer Institute (NCI)

About this trial

This research trial studies biomarkers in predicting treatment response in samples from patients with early-stage non-small cell lung cancer previously treated with adjuvant chemotherapy. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

International Adjuvant Lung Cancer Trail (IALT)

Cancer and Leukemia Group B (CALGB)-9633

CAN-NCIC-BR10

Adjuvant Navelbine International Trialist Association (ANITA)

Disqualifiers

None

Trial design

Treatments tested in this trial

medical chart review
Other intervention
Correlative studies
laboratory biomarker analysis
Other intervention
Correlative studies

Treatment groups

950 Participants

are divided into 1 treatment group

Group A: Ancillary-Correlative (laboratory biomarkre analysis)2 interventions

Trial outcomes

Primary outcomes

Validation of the 15-gene prognostic and predictive mRNA signature by quantitative Nuclease Protection Assay (qNPA) assay and NanoString assay

Time frame

Post-RNA extraction from tissue

Prognostic and predictive value of known potential oncogenic mutations and gene copy variations of novel genomic aberrations on disease free survival (DFS) and overall survival (OS)

Survival curves will be estimated using Kaplan-Meier methods and compared with the log-rank test. The hypothesis of constant risk ratio over time in the Cox proportional hazards (PH) model will be tested by introducing a time-dependent interaction with the marker or using Schoenfeld's residuals.

Time frame

Post-RNA extraction from tissue

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: