Clinical trial · Interventional
First-Line Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Genotype-driven Treatment of Advanced Non-small Cell Lung Cancer Based on mRNA Expression of ERCC1 & RRM1 as First-line Chemotherapy
- 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)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating non-small cell lung cancer. PURPOSE: This randomized phase II trial is comparing different combination chemotherapy regimens to see how well they work as first-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer that cannot be removed by surgery.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| vinorelbine tartrate | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Patients receive standard chemotherapy of docetaxel and carboplatin.
- interventionNames
- Drug: carboplatin
- Drug: docetaxel
- type
- EXPERIMENTAL
- label
- Arm II, Genotype A1
- description
- Patients receive docetaxel and vinorelbine ditartrate.
- interventionNames
- Drug: docetaxel
- Drug: vinorelbine tartrate
- type
- EXPERIMENTAL
- label
- Arm II, Genotype A2
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven or radiologically and clinically suspected stage IIIB (with malignant pleural effusion) or IV non-small cell lung cancer * Unresectable disease * At least 1 measurable lesion (\> 10 mm with spiral CT scan or \> 20 mm with conventional CT scan) * No symptomatic or untreated brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy \> 12 weeks * ANC ≥ 1,500/mm³ * Hemoglobin \> 9.0 g/dL * Platelet count ≥ 100,000/mm³ * AST and ALT \< 2 times upper limit of normal (ULN) * Bilirubin \< 1.5 mg/dL * Creatinine \< 1.5 times ULN * Not pregnant or nursing * No serious uncontrolled systemic intercurrent illness, including any of the following: * Acute myocardial infarction * Uncontrolled arrhythmia * Uncontrolled heart failure * Sepsis * Poorly controlled diabetes * No other malignancy within the last 5 years, except for carcinoma in situ of the cervix or nonmelanomatous carcinoma of the skin PRIOR CONCURRENT THERAPY: * At least 3 weeks since prior radiotherapy, including cranial irradiation * At least 3 weeks since prior major surgery * No prior systemic chemotherapy except adjuvant chemotherapy provided it was completed more than 12 months ago
References
Publications (0)
Data not yet available