Clinical trial · Interventional
Study of an Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer
A Randomized Phase II Trial of Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced 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 optimal strategy in advanced non small cell lung cancer with stable disease is not well known. There is no published study assessing an early change of chemotherapeutic drugs in these patients.Accordingly, we conduct this trial with the objective to improve the rate of objective responses by the switch to another doublet after 2 cycles of CDDP-gemcitabine association for patients with stable diseases (SD).
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 Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Taxol | Drug | Taxol | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- 1-Complete response
- measure
- 2-Partial response
- measure
- 3-Stable disease
- measure
- 4-Progression
Secondary outcomes (1)
- measure
- -Toxicity (NCI-CTC criteria)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically proved stage IV or pleural stage III NSCLC (neoplastic pleurisy confirmed). * Metastatic relapses allowed in not irradiated area. * Age between 18 and 70 years * Chemonaïve patients * At least one measurable target lesion according to recist criteria in non previously irradiated area. * Performance status \< 2 * Normal hepatic and renal function, absolute neutrophil count \>1,5 giga/l, platelets \>100 giga/l. * Written informed consent. * Life expectancy \> 12 weeks. Exclusion Criteria: * SCLC, bronchial-alveolar and neuro-endocrine carcinoma. * Previous chemotherapeutic treatment. * Symptomatic brain metastases. * Superior vena cava syndrome. * Other concomitant diseases: heart failure, angina pectoris, arrhythmia , recent myocardial infarction. * Peripheral neuropathy grade ≥2. * Past or concomitance of another cancer except baso-cellular carcinoma of the skin or in situ cervical carcinoma. * Hypersensitivity to paclitaxel or polysorbate 80. * Pregnancy or breast feeding. * Any concomitant radiotherapy, except palliative bone irradiation. * Follow-up of the patient impossible. * Prisoners.
References
Publications (1)
- RESULTVergnenegre A, Tillon J, Corre R, Barlesi F, Berard H, Vernejoux JM, Le Caer H, Fournel P, Marin B, Chouaid C. A randomized phase II trial assessing in advanced non-small cell lung cancer patients with stable disease after two courses of cisplatin-gemcitabine an early modification of chemotherapy doublet with paclitaxel-gemcitabine versus continuation of cisplatin-gemcitabine chemotherapy (GFPC 03-01 Study). J Thorac Oncol. 2009 Mar;4(3):364-70. doi: 10.1097/JTO.0b013e318197f4ff. PMID 19155999