Clinical trial · Interventional
Evaluation of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation for Non-resectable Stage III NSCLC
A Multicenter Phase II Study of Carboplatin Plus Gemcitabine Followed by Concomitant Chemoradiation in Patients With Non-resectable Stage III 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 aim of this study is to evaluate whether by combining a carboplatin-gemcitabine based induction chemotherapy with weekly cisplatin during standard thoracic radiotherapy it is possible to obtain optimal efficacy with minimal toxicity. Patients will be treated with 3 cycles of induction chemotherapy, unless there is the occurrence of early intrathoracic progression of disease. The induction chemotherapy is then to be followed by chemo-radiotherapy.
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 |
|---|---|---|---|
| carboplatin/gemcitabine | Drug | — | UNRESOLVED |
| cisplatin/radiation therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 2-year survival rates
Secondary outcomes (5)
- measure
- Response rate
- measure
- Time to intrathoracic failure
- measure
- Overall survival
- measure
- Toxicity of induction chemotherapy
- measure
- Toxicity of chemo-radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * cytological or histologically proven NSCLC * unresectable stage III NSCLC * presence of at least one measurable lesion (RECIST criteria) * adequate haematological, renal and hepatic function * adequate lung function reserve * good condition, weight loss \<10% over previous 6 months, life expectancy \> 3 months Exclusion Criteria: * previous chemotherapy for NSCLC * distant metastasis or a pleural or pericardial effusion * treatment for malignant disease in the past or serious concomitant medical or psychiatric disease * active uncontrolled infection at time of inclusion * interstitial lung disease * auto-immune systemic disease with potential involvement of the lungs * concomitant use of amiodarone
References
Publications (0)
Data not yet available