Clinical trial · Interventional
Study for Therapy of Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) With Cisplatin / Docetaxel or Oxaliplatin / Docetaxel
Multicenter Randomized Phase II Study for the Therapy of Locally Advanced or Metastatic NSCLC (Stage IIIB/IV) With Cisplatin/Docetaxel or Oxaliplatin/Docetaxel
- 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 compares two combinations of chemotherapy in patients with advanced or metastatic NSCLC: 50% of the patients are treated with cisplatin and docetaxel, the other 50% with oxaliplatin and docetaxel. cisplatin is today the standard therapy, but the toxicity profile is often not tolerable. Especially in elderly patients or patients with comorbidities, oxaliplatin based chemotherapy may have lower toxicities but comparable or even better response rates.
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 |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A cisplatin
- description
- Cisplatin 75 mg/m2, d1 Docetaxel 75 mg/m2, d1 every 3 weeks (d22) max. 6 cycles
- interventionNames
- Drug: Cisplatin
- Drug: Docetaxel
- type
- EXPERIMENTAL
- label
- Arm B oxaliplatin
- description
- Oxaliplatin 85 mg/m², d1 Docetaxel 50mg/m2, d1 every 2 weeks (d15) max. 8 cycles
- interventionNames
- Drug: Oxaliplatin
- Drug: Docetaxel
Primary outcomes (1)
- measure
- response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically or cytologically confirmed NSCLC stage IIIB or IV. * no previous chemotherapy in metastatic state * male and female patients aged \> 18 years * ECOG ≤ 2 * Leukocytes \> 3.000/µl * Thrombocytes \> 100.000/µl * Serum creatinine ≤ 1.25x normal value, or Creatinine Clearance \> 45 ml/min * previous radiation \< 25% bone marrow region allowed. Previous radiation of whole pelvis not allowed * parallel radiation allowed, if target lesion outside of radiation field * written informed consent * life expectancy \> 3 months Exclusion Criteria: * hypersensibility against Cisplatin, Oxaliplatin or Docetaxel * Neoadjuvant or adjuvant chemotherapy within the last 6 months * radiation within the last 28 days * severe systemic comorbidities * Cardiomyopathy or cardiac insufficiency stage II-IV according to NYHA * malignant secondary disease, dated back \< 5 years (exception: In-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma) * brain metastases * severe non-surgical comorbidities or acute infection * peripheral polyneuropathy \> NCI grade II * severe liver dysfunction AST/ALT\>3,5xULN, AP\>6xULN, Bilirubin\>1,5xULN) * participation in parallel trial * pregnancy and lactation * reduced hearing
References
Publications (0)
Data not yet available