Clinical trial · Interventional
Gene Expression Levels in Predicting Treatment Response in Patients With Stage IV Non-small Cell Lung Cancer
A Pilot Trial of Platinum, Gemcitabine, or Pemetrexed Single- or Multi-Agent Therapy With Serial Tumor Specimen Collection in Patients With Advanced Non-Small-Cell Lung Cancer
NCT02145078CI-TRIAL-00047316terminatedN/AResults postedClinicalTrials.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): Slow accrual.
Summary
Brief summary (as posted)
This pilot clinical trial studies whether the levels of certain genes in the tissue and blood are related to how well patients with stage IV non-small cell lung cancer respond to chemotherapy. Genes may affect how sensitive or resistant tumors are to chemotherapy. Studying the levels of genes related to tumor response before and after chemotherapy may help doctors learn whether they can predict how well patients will respond to treatment.
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 |
|---|---|---|---|
| Recurrent Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pemetrexed disodium | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemotherapy regimen)
- description
- Patients receive 1 of 4 chemotherapy regimens at the discretion of the primary oncologist following institutional guidelines, including cisplatin, carboplatin, pemetrexed disodium IV on day 1, or gemcitabine hydrochloride IV on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. After course 2, patients may continue treatment off-study at the discretion of the treating physician.
- interventionNames
- Drug: docetaxel
- Drug: pemetrexed disodium
- Drug: gemcitabine hydrochloride
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Baseline Marker Measurement
- timeFrame
- Baseline
- description
- A univariable regression of continuous disease response on baseline marker value will be performed. A multivariable regression model adjusted for clinical covariates will be evaluated as well. Expression levels of RRM1, TS, BRCA1, and other molecules and disease response after course 2 will be log-transformed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with advanced stage NSCLC who are candidates for single or multi-agent first-line therapy. * Second-line or higher therapy for any patients with NSCLC with performance status (PS) 0-2 * Maintenance therapy for patients after completion of four cycles of dual-agent platinum-based chemotherapy * Stage IV, histologically or cytologically confirmed NSCLC; confirmation may be obtained with the first protocol-specified tumor biopsy * White blood cell count \> 3000/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 9.0 g/dl * A tumor lesion that can be safely biopsied as judged by the treating oncologist and physician performing the procedure and has not been radiated * At least one unidimensionally measurable tumor lesion \>= 1 cm in longest diameter using spiral CT (\>= 2 cm in longest diameter by any other technique) that has not been radiated and is not located in a bone * Performance status 0-2 by Eastern Cooperative Oncology Group criteria * Life expectancy of \>= 3 months * Able to understand and sign the informed consent document Exclusion Criteria: * Therapy that does not include cisplatin, carboplatin, gemcitabine, and/or pemetrexed * Concomitant medical or psychiatric illness that is likely to interfere with a reasonably safe execution of the treatment plan * Concomitant malignancy other than NSCLC that requires active therapy; prior malignancies are allowed as long as the disease is controlled and does not require ongoing therapy of any kind; prior therapy must have concluded at least 1 year before treatment initiation on this protocol; exceptions are non-melanoma skin cancer, prostate cancer and prostatic intraepithelial neoplasia (PIN) treated with local intervention and deemed cured, cervical cancer and carcinoma in situ (CIS) treated with local intervention and deemed cured, and laryngeal cancer and CIS treated with local intervention and deemed cured * Carcinomatous meningitis * Uncontrolled central nervous system (CNS) disease * The time interval between CNS radiation, whole brain radiation, spinal cord radiation, or radiosurgery, and initiation of protocol specified chemotherapy must be at least 1 week * Malignant pleural, pericardial, or peritoneal effusion if it is the only site of disease activity; i.e., if no other measurable tumor lesions exist * Coagulopathy or anticoagulation therapy that cannot be safely corrected or interrupted for tumor biopsy * Significant hepatic dysfunction, renal dysfunction, or metabolic derangement that precludes full-dose chemotherapy at the specified starting doses * Concomitant treatment with chemotherapeutic agents for diseases other than malignancy * Pregnancy or lactation
References
Publications (0)
Data not yet available
No reference posted for this study.