Clinical trial · Interventional
Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Phase II Study of Oxaliplatin in Combination With Gemcitabine for 2 Line Treatment of NSCLC Patients With Advanced and Metastatic Disease
- 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, such as gemcitabine and oxaliplatin, 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. PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works as second-line therapy in treating patients with stage III or stage IV non-small cell lung cancer.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate as measured by RECIST criteria
- timeFrame
- At study completion
Secondary outcomes (1)
- measure
- Toxicity as monitored by DSMC
- timeFrame
- At study completion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically proven stage IIIB or IV non-small cell lung cancer (NSCLC)
* Failed first-line chemotherapy
* Must have received ≥ 1, but no more than 2, prior chemotherapy regimens for stage IIIB or IV NSCLC
* Prior radiotherapy or surgery for earlier stage disease allowed, provided target lesions chosen for response assessment have not have been irradiated
* At least 1 unidimensionally measurable lesion with diameter ≥ 20 mm by conventional methods OR ≥ 10 mm by spiral CT scan
* If a single lesion is identified as the target lesion, histological or cytological confirmation of this lesion is required
* No symptomatic brain metastases
* Clinically stable brain metastases on a stable dose of (or no longer requiring) dexamethasone allowed
PATIENT CHARACTERISTICS:
* ECOG performance status 0 or 1
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ 1.5 mg/dL
* AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver involvement)
* Creatinine ≤ 1.5 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 months after completion of study treatment
* No history of an acute cardiac or CNS event within the past 6 months, including any of the following:
* Unstable angina
* Myocardial infarction
* Clinically relevant arrhythmia
* Stroke
* No current clinical evidence of congestive heart failure or unstable coronary artery disease
* No peripheral neuropathy \> grade 1
* No history of hypersensitivity to study drugs
* No serious uncontrolled medical or psychiatric illness, including any of the following:
* Serious infection
* Interstitial pneumonia
* Extensive and symptomatic fibrosis of the lung
* No other malignancy within the past year, except for squamous cell or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from prior surgery
* At least 4 weeks since prior cranial radiation for brain metastases
* More than 4 weeks since prior participation in another investigational drug study
* No concurrent immunotherapyReferences
Publications (0)
Data not yet available