Clinical trial · Interventional
Ph II Concurrent Chemo t/Docetaxel/Carboplatin/Radio Therapy-consolidation t/Locally Adv Inoperable Non-Small Cell Lung Cancer (NSCLC)
PhII Study of Concurrent Chemoradiotherapy With Weekly Docetaxel, Carboplatin and Radiation Therapy Followed by Consolidation Chemotherapy With Docetaxel and Carboplatin for Locally Advanced Inoperable Non-small Cell Lung Cancer (NSCLC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Treatment became standard.
Summary
Brief summary (as posted)
RATIONALE: Because of its success in advanced NSCLC both as a single agent and in combination with other chemotherapeutics, it is reasonable to investigate the efficacy and toxicity of docetaxel as a multimodality regimen in this patient population. Docetaxel at a dose of 20 mg/m2 appears to be a well-tolerated "weekly" dose when combined with either cisplatin 25 mg/m2 20-22 or carboplatin area under the curve (AUC) 2 23-25 concomitant with radiation therapy. PURPOSE: To explore the potential benefits of the radiosensitizing effects of weekly docetaxel/carboplatin/radio therapy concurrent therapy followed full dose systemic docetaxel/carboplatin consolidation therapy on overall response rate, survival, progression-free survival, safety and toxicity in patients with locally advanced NSCLC.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Therapeutic Intervention
- interventionNames
- Drug: Carboplatin
- Drug: Docetaxel
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 14.95 months (average duration, on study date to off-study date)
- description
- Months from on-study to expired/last date known alive.
Secondary outcomes (3)
- measure
- Overall Response Rate
- timeFrame
- on-study date to date of best response
- description
- Patient response to treatment per RECIST: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must voluntarily sign and date an informed consent before the initiation of any study procedures * Patients must have non-metastatic, inoperable, Stage IIIA or IIIB histologically or cytologically documented NSCLC without evidence of malignant pleural effusion * Patients must not have received any prior systemic chemotherapy, thoracic radiotherapy or surgical resection for treatment of NSCLC * Patients must have at least one site of unidirectionally measurable disease * Patients must be ≥ 3 weeks from a formal exploratory thoracotomy * Patients must have a Radiation Oncology and Medical Oncology consult and approval prior to study entry * Patients must be ≥ 18 years of age * Women of childbearing potential must have a negative baseline serum pregnancy within 7 days prior to Week 1, Day 1 and must not be breast feeding. * Women of childbearing potential and men with a sexual partner of child bearing potential must use an effective method of contraception beginning prior to study entry, for the duration of the study participation and for a minimum of 3 months after the last dose of chemotherapy. * Patients must have adequate hepatic, renal, lung and bone marrow function as defined below: * Absolute neutrophil count (ANC) \> 1,500/mm3 * Hemoglobin \> 9.0 gm/dL * Creatinine \< 1.5 * Platelets \> 100,000/mm3 * Total bilirubin within normal limits (WNL) * AST or ALT and Alkaline Phosphatase must be within the range allowing for eligibility, as per chart on page 10 of the protocol. * Calculated CrCl \> 50 ml/min (via Cockroft-Gault formula). * Forced expiratory volume in 1 second (FEV 1) \> 800 ml Exclusion Criteria: * Known hypersensitivity to drugs formulated with polysorbate 80 * Peripheral neuropathy Grade ≥ 2. * Wet stage IIIB (documented malignant pleural effusion) or stage IV NSCLC * Previous chemotherapy or radiation therapy * Any concomitant malignancy, brain metastasis or uncontrolled, clinically significant medical or psychiatric disorder * Pregnant or nursing women * A greater than or equal to 10% weight loss over the past 3 months
References
Publications (0)
Data not yet available