Clinical trial · Interventional
Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer
Phase II Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With 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 goals of this study are: * to determine if the combination of two drugs, motexafin gadolinium and pemetrexed, may be an effective treatment for patients with non-small cell lung cancer (NSCLC) who have had one previous chemotherapy regimen that included a platinum containing drug such as cisplatin or carboplatin. * to assess response to treatment in patients with NSCLC six months after beginning study treatment.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Motexafin gadolinium and pemetrexed | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Xcytrin® (motexafin gadolinium)
- interventionNames
- Drug: Motexafin gadolinium and pemetrexed
Primary outcomes (1)
- measure
- 6 month progression free survival
- timeFrame
- up to 2 years
- description
- proportion of patients who are still alive and who have not progressed clinically or radiographically 6 months after receiving their first dose of MGd.
Secondary outcomes (7)
- measure
- Time to disease progression
- timeFrame
- up to 2 years
- description
- Time to progression is defined as the time from first dose of MGd to first evidence of progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years or older * Stage IIIb, metastatic, or recurrent NSCLC patients who have received one prior platinum-based chemotherapy regimen * ECOG performance status score of 0 or 1 Exclusion Criteria: * Laboratory values indicating inadequate function of bone marrow, liver, or kidneys * Symptomatic or uncontrolled brain metastases * Evidence of meningeal metastasis * \> 1 prior regimen (not counting adjuvant or neo-adjuvant cytotoxic chemotherapy if completed \> 12 months prior to regiment) * Medical condition that would increase risk if treated with motexafin gadolinium or impair ability to complete study procedures and assessments
References
Publications (2)
- BACKGROUNDBiaglow JE, Miller RA. The thioredoxin reductase/thioredoxin system: novel redox targets for cancer therapy. Cancer Biol Ther. 2005 Jan;4(1):6-13. doi: 10.4161/cbt.4.1.1434. Epub 2004 Jan 8. PMID 15684606
- BACKGROUNDEvens AM. Motexafin gadolinium: a redox-active tumor selective agent for the treatment of cancer. Curr Opin Oncol. 2004 Nov;16(6):576-80. doi: 10.1097/01.cco.0000142073.29850.98. PMID 15627019