Clinical trial · Interventional
Oshadi D and Oshadi R in Combination With Docetaxel, as 2nd Line Therapy for Metastatic Non Small Cell Lung Cancer
A Phase IIa, Open-Label, Single- Center Study to Assess the Activity of Oshadi D and Oshadi R in Combination With Docetaxel, as 2nd Line Therapy for Metastatic Non Small Cell Lung Cancer
- 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)
The study will be a prospective open-label single-center study in previously treated patients with Non Small Cell Lung Cancer (NSCLC). Treatment efficacy and safety of the combination of Oshadi D and Oshadi R with Docetaxel will be will be evaluated. Patients will receive Docetaxel in combination with Oshadi D and Oshadi R. Patient will be evaluated throughout the study for safety and tolerance to multiple dose regimens of Oshadi D and Oshadi R. CT or MRI imaging will be performed prior to treatment initiation and at the end of every 3 Docetaxel cycles (12 weeks). In case of disease progression, dose augmentation will be considered or subsequent therapy.
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 |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Oshadi D and Oshadi R | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oshadi D and Oshadi R with Docetaxel
- description
- Oshadi D and Oshadi R anti cancer agents with Docetaxol chemotherapy
- interventionNames
- Drug: Oshadi D and Oshadi R
- Drug: Docetaxel
Primary outcomes (1)
- measure
- overall survival time
- timeFrame
- 12 months
- description
- overall survival of the patient
Secondary outcomes (2)
- measure
- Adverse events and serious adverse events occurence
- timeFrame
- One month following treatment initiation
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Locally advanced or metastatic NSCLC (IIIB-IV) * Failure of first line anti-cancer therapy (either radiological documentation of disease progression or due to toxicity) in advanced disease or subsequent relapse of disease following first line therapy * Man or woman 21 years and above * Adequate performance status (ECOG 0, and 1) * Patient must have adequate organ function * Written informed consent * Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation. * Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy. Exclusion Criteria: * Any treatment with investigational agent within 10 days prior to registration for protocol therapy. * Cerebrovascular accident, transient ischemic attack or myocardial infarction within 3 months prior to registration for protocol therapy. * Evidence of pulmonary embolism within 3 months prior to registration for protocol therapy. * Any history of hematologic malignancies. * Patient with known positive HIV serology at screening. * Female patient who are breastfeeding or have a positive pregnancy test at screening or at any time during the study. * Uncontrolled hypertension (\>160/100 mm Hg despite optimal medical therapy). * Evidence of ongoing cardiac dysrhythmias of NCI CTCAE (Common Toxicity Criteria for Adverse Effects) Version 3.0 grade 2. * Patients in whom radiation or surgery is indicated * Significant swallowing disorders. * Small bowel surgery. * Suspicion of absorption disruption as a result of abdominal radiation * Pre-existing mal absorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption. * Evidence of concurrent (\< 5 years) second malignancy * Mental disorders. * Inability to give written informed consent.
References
Publications (0)
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