Clinical trial · Interventional
BELotaxel(Docetaxel) and bellOXa(Oxaliplatin) in Advanced NSCLC
Phase II Trial of First Line Docetaxel and Oxaliplatin in Stage IV or Relapsed 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)
Lung cancer is the leading cause of cancer death in Korea as well as in other countries. About 80% of lung cancer is non-small cell lung cancer(NSCLC). The majority of patients with NSCLC require cytotoxic chemotherapy in the course of their illness. Combination chemotherapy using third generation anticancer drugs (paclitaxel, docetaxel, gemcitabine) with platinums(cisplatin or carboplatin) reached a plateau in their efficacy. Oxaliplatin, another platinum being used for colorectal, gastric and pancreatic cancer has lower adverse effects such as nausea and nephrotoxicity. In this phase II trial, we will observe efficacy and safety of docetaxel and oxaliplatin for patients with 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 |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Belloxa | Drug | — | UNRESOLVED |
| Belotaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Belotaxel plus Belloxa
- description
- Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
- interventionNames
- Drug: Belotaxel
- Drug: Belloxa
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- 6th week
- description
- RECIST version 1.1
Secondary outcomes (3)
- measure
- Progression Free Survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage IIIB/IV or Relapsed NSCLC * Age \>= 18 years * At least one measurable lesion by RECIST (version 1.1) * ECOG PS 0, 1, 2 * Hematologic profile * Hgb \> 8 g/dL, ANC \>= 2,000/m3, Platelet \>= 100,000/m3 * Hepatic profile * Total bilirubin \<= 1.5 x upper normal value * Transaminases \<= 3 x upper normal value \<= 5 x upper normal value in case of liver metastasis * Creatinine \<= 1.5mg/dL * Patients should be recovered from toxicities of previous treatment. * Written informed consent by patient or surrogates Exclusion Criteria: * Patients who had been previously treated with chemotherapy for NSCLC * Active infection requiring antibiotics treatment * Prior diagnosis of other malignancy except radically treated basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the uterine cervix * Peripheral neuropathy \>= grade 2 by NCI CTCAE 4.0 * Uncontrolled hypertension, Acute myocardial infarction within 6 months Unstable angina, Congestive heart failure \>= NYHA grade 2 Uncontrolled significant arrhythmia * Patients who entered other clinical trials within 4 weeks * Pregnant or lactating women. women with child bearing age who are not willing to a contraceptive measure
References
Publications (1)
- RESULTBan H, Kim KS, Oh IJ, Yoon SH, Lee B, Yu J, Kim S, Lee HS, Shin HJ, Park CK, Kwon YS, Kim YI, Lim SC, Kim YC. Efficacy and safety of docetaxel plus oxaliplatin as a first-line chemotherapy in patients with advanced or metastatic non-small cell lung cancer. Thorac Cancer. 2014 Nov;5(6):525-9. doi: 10.1111/1759-7714.12123. Epub 2014 Oct 23. PMID 26767047