Clinical trial · Interventional
Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC
Randomized Phase II Study of Pemetrexed Versus Pemetrexed and Carboplatin as Second Line Chemotherapy in Advanced Non-small-cell Lung Cancer (NSCLC).
NCT00786331CI-TRIAL-00002508unknownPhase 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)
The aim of this study is to compare time to progression between the combination pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally advanced or metastatic 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 |
|---|---|---|---|
| Advanced Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Pemetrexed plus carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Monochemotherapy
- interventionNames
- Drug: Pemetrexed
- type
- EXPERIMENTAL
- label
- B
- description
- Combination chemotherapy
- interventionNames
- Drug: Pemetrexed plus carboplatin
Primary outcomes (1)
- measure
- To compare time to progression between the combination pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally advanced or metastatic NSCLC
- timeFrame
- 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * written informed consent * Histologically or cytologically confirmed non-small-cell lung cancer * Unresectable stage IIIB, stage IV and unresectable local relapse or metastatic disease, with evidence of disease progression after first line chemotherapy which should have included a platinum agent. * ECOG performance status lower than or equal to 2 * Adequate hematological, hepatic and renal functions * Life expectancy greater than or equal to 12 weeks * Prior treatment with only 1 chemotherapy regimen for the treatment of advanced disease which should have included a platinum agent * At baseline, presence of at least one measurable target lesion as per RECIST criteria Exclusion Criteria: * Prior treatment with pemetrexed. * Patients who are pregnant or lactating * Patients with any underlying medical condition that might be aggravated by treatment or which cannot be controlled. * Symptomatic brain metastases * History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix. * Concomitant treatment with any other anticancer drug.
References
Publications (2)
- DERIVEDvan Kruijsdijk RC, Visseren FL, Boni L, Groen HJ, Dingemans AM, Aerts JG, van der Graaf Y, Ardizzoni A, Smit EF. Pemetrexed plus carboplatin versus pemetrexed in pretreated patients with advanced non-squamous non-small-cell lung cancer: treating the right patients based on individualized treatment effect prediction. Ann Oncol. 2016 Jul;27(7):1280-6. doi: 10.1093/annonc/mdw154. Epub 2016 Apr 6. PMID 27052652
- DERIVEDArdizzoni A, Tiseo M, Boni L, Vincent AD, Passalacqua R, Buti S, Amoroso D, Camerini A, Labianca R, Genestreti G, Boni C, Ciuffreda L, Di Costanzo F, de Marinis F, Crino L, Santo A, Pazzola A, Barbieri F, Zilembo N, Colantonio I, Tibaldi C, Mattioli R, Cafferata MA, Camisa R, Smit EF. Pemetrexed versus pemetrexed and carboplatin as second-line chemotherapy in advanced non-small-cell lung cancer: results of the GOIRC 02-2006 randomized phase II study and pooled analysis with the NVALT7 trial. J Clin Oncol. 2012 Dec 20;30(36):4501-7. doi: 10.1200/JCO.2012.43.6758. Epub 2012 Oct 29. PMID 23109689