Clinical trial · Observational
Pharmacogenetics in Non Small Cell Lung Cancer
Effect of Copper Transporter-1 Genetic Polymorphism on Platinum Based Chemotherapy Response in Advanced Non-Small Cell Lung Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Study the effect of genetic polymorphism in the membrane copper transporter 1 protein \[CTR1; encoded by the solute carrier family 31 member 1 gene (SLC31A1 gene)\] and its genetic expression levels on the clinical outcome of cisplatin-based regimen used in the treatment of Non-Small Cell Lung Cancer (NSCLC) in terms of : * Treatment response : partial response (PR) / complete response (CR) and Progression-free survival (PFS) * Treatment resistance : stationary disease (SD) or progressed disease * Frequency and severity of regimen related toxicity
Conditions
Conditions (1)
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 | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Tumor response and resistance
- timeFrame
- 1 year
- description
- will be evaluated after the third (initial evaluation response) and the sixth (confirmation of initial response) chemotherapy cycle according to the new Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Secondary outcomes (2)
- measure
- Progression-free survival (PFS)
- timeFrame
- 1.5 years
- description
- defined as the time from day 1 of chemotherapy to the day of documented disease progression or death.
- measure
- Regimen related toxicity
- timeFrame
- 1.5 years
- description
- 1\. Hematologic toxicity (anemia, neutropenia, and thrombocytopenia) 2. Nephrotoxicity 3. Ototoxicity 4. Neurotoxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed with immunohistochemically and pathologically confirmed non- small cell lung cancer (NSCLC). 2. ECOG PS 0-2. 3. Chemotherapy naïve. 4. Age \>18 years. 5. Adequate bone marrow reserve. Exclusion Criteria: 1. Presence of central nervous system metastases. 2. Inadequate liver function (bilirubin \> 1.5 times upper normal limit \[ULN\] and alanine transaminase \[ALT\] or aspartate transaminase \[AST\] \> 3.0 ULN or up to 5.0 UNL in the presence of hepatic metastases). 3. Inadequate renal function (creatinine \> 1.25 times ULN, creatinine clearance \< 50mL/min). 4. Serious comorbid systemic disorder incompatible with the study. 5. Second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior to enrollment without recurrence). 6. Pregnancy
References
Publications (3)
- BACKGROUNDBlair BG, Larson CA, Safaei R, Howell SB. Copper transporter 2 regulates the cellular accumulation and cytotoxicity of Cisplatin and Carboplatin. Clin Cancer Res. 2009 Jul 1;15(13):4312-21. doi: 10.1158/1078-0432.CCR-09-0311. Epub 2009 Jun 9. PMID 19509135
- BACKGROUNDRoco A, Cayun J, Contreras S, Stojanova J, Quinones L. Can pharmacogenetics explain efficacy and safety of cisplatin pharmacotherapy? Front Genet. 2014 Nov 14;5:391. doi: 10.3389/fgene.2014.00391. eCollection 2014. PMID 25452763
- BACKGROUNDXu X, Ren H, Zhou B, Zhao Y, Yuan R, Ma R, Zhou H, Liu Z. Prediction of copper transport protein 1 (CTR1) genotype on severe cisplatin induced toxicity in non-small cell lung cancer (NSCLC) patients. Lung Cancer. 2012 Aug;77(2):438-42. doi: 10.1016/j.lungcan.2012.03.023. Epub 2012 Apr 17. PMID 22516052