Clinical trial · Interventional
Irinotecan Plus Cisplatin vs Pemetrexed Plus Cisplatin as 2nd Line in NSCLC Stage IIIB/IV
A Multicenter Randomized Phase II Study of the Combination of Irinotecan/Cisplatin Versus Pemetrexed/Cisplatin as Second-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)
NCT00614965CI-TRIAL-00004900completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This trial will compare the efficacy of irinotecan/cisplatin and pemetrexed/cisplatin in the second-line treatment of patients with stage IIIB/IV NSCLC
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 |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- IC
- interventionNames
- Drug: Irinotecan
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- 2
- description
- PC
- interventionNames
- Drug: Cisplatin
- Drug: Pemetrexed
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed NSCLC * Age 18 -75 years * Performance status (WHO) \<2 * Patients progressing after first-line docetaxel/gemcitabine treatment * Adequate bone marrow (absolute neutrophil count \>1000/mm3, platelet count \>100000/mm3, hemoglobin \> 9 gr/ mm3) * Adequate liver (bilirubin \<1.5 times upper limit of normal), renal (Creatinine clearance \> 50mg/min) and cardiac (LVEF \>50%) function * Presence of measurable disease (according to RESIST criteria) * Informed consent Exclusion Criteria: * Psychiatric illness or social situation that would preclude study compliance' * Other concurrent uncontrolled illness. * Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
References
Publications (1)
- DERIVEDKentepozidis N, Economopoulou P, Christofyllakis C, Chelis L, Polyzos A, Vardakis N, Koinis F, Vamvakas L, Katsaounis P, Kalbakis K, Nikolaou C, Georgoulias V, Kotsakis A. Salvage treatment with irinotecan/cisplatin versus pemetrexed/cisplatin in patients with non-small cell lung cancer pre-treated with a non-platinum-based regimen in the first-line setting: a randomized phase II study of the Hellenic Oncology Research Group (HORG). Clin Transl Oncol. 2017 Mar;19(3):317-325. doi: 10.1007/s12094-016-1532-y. Epub 2016 Aug 4. PMID 27492015