Clinical trial · Interventional
Dose-Dense Induction/Neoadjuvant Chemotherapy in Locally Advanced Non-Small Cell Lung Cancer
Dose-Dense Induction/Neoadjuvant Chemotherapy in the Treatment of Patients With Locally Advanced Non-Small Cell Lung Cancer With Additional Genomic Analyses to Identify Signatures Predictive of Chemotherapy Response.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient accrual to meet analysis goals
Summary
Brief summary (as posted)
Dose-dense chemotherapy is a chemotherapy treatment plan in which drugs are given with less time between treatments than in standard chemotherapy. The two chemotherapy drugs used in this study, docetaxel and cisplatin, are approved for the treatment of lung cancer when given every 21 days. This study is exploring the response to chemotherapy when these drugs are given every 14 days. In addition, genetic tests will be performed on pre-treatment specimens to identify signatures that may predict chemotherapy sensitivity or resistance.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Pegfilgrastim | Drug | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Induction Chemotherapy
- description
- Cisplatin 75mg/m2 IV days 1, 15, 29; Docetaxel 75mg/m2 IV days 1, 15, 29; and Pegfilgrastim 6mg SC day 2, 16, 30
- interventionNames
- Drug: cisplatin
- Drug: Docetaxel
- Drug: Pegfilgrastim
Primary outcomes (2)
- measure
- Induction Response
- timeFrame
- Between 2 and 3 weeks after induction
- description
- Response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Response is defined as the number patients with a Complete Response (CR), disappearance of all target lesions, or a Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions.
- measure
- Differential Gene Expression Between Responsive and Resistant Tumor Treated With Dose-dense Therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with documented stage III NSCLC (IIIA or IIIB, without malignant pleural/pericardial effusion) are eligible for enrollment if they are considered appropriate for treatment with chemotherapy, radiation, or surgery; * IIIA: T1-3 N2 M0, T3 N1 M0 * IIIB: T4 N0-2 M0, T 1-4 N3 M0 * Measurable or evaluable disease * Previously untreated with chemotherapy or radiotherapy for lung cancer; * No brain metastases; * No prior XRT * Performance status 0-2 * ≥18 years of age * Informed Consent * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L * Platelets ≥ 100 x 109/L * Bilirubin ≤ 1.5 x upper limit of normal for the institution (ULN) * SGOT and SGPT ≤ 2.5 x ULN for the institution * Creatinine ≤ 1.6 mg/dL * Hemoglobin ≥ 8.0 g/dL * Peripheral neuropathy ≤ grade 1 Exclusion Criteria: * Known sensitivity to E. coli derived products (e.g. Filgrastim, HUMULIN® insulin, L-asparaginase, HUMATROPE® Growth Hormone, INTRON® A); * Use of IV systemic antibiotics within 72 hours prior to chemotherapy; * Known HIV infection * Lithium or cytokines within 2 weeks prior of entry * Additional concurrent investigational drugs * History of myelodysplastic syndrome * Pregnant, nursing or having unprotected sex * Not available for follow-up assessment * Unable to comply with protocol procedures * Illnesses that may compromise ability to give informed consent. * Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80.
References
Publications (0)
Data not yet available