Clinical trial · Interventional
Dosage Schedule Study of Pemetrexed Monochemotherapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Pemetrexed Monochemotherapy in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer. A Pilot Study to Define the Best Dosing Schedule for a Planned Phase II Randomized Trial
- 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)
Patients affected by non-small cell lung cancer (NSCLC) will be treated in pemetrexed monochemotherapy regimen for a maximum of 8 cycles. Pemetrexed is an enhancer of some biomolecules involved in the gemcitabine mechanism of action. Purpose of the trial is to monitor the blood values of these biomolecules at different time intervals, to optimize the synergism between pemetrexed and gemcitabine.
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 |
|---|---|---|---|
| Pemetrexed - After Protocol Amendment | Drug | — | UNRESOLVED |
| Pemetrexed - Before Protocol Amendment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pemetrexed - Before Protocol Amendment
- interventionNames
- Drug: Pemetrexed - Before Protocol Amendment
- type
- EXPERIMENTAL
- label
- Pemetrexed - After Protocol Amendment
- interventionNames
- Drug: Pemetrexed - After Protocol Amendment
Primary outcomes (2)
- measure
- Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
- timeFrame
- pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)
- description
- dCK and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction \[PCR\] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Histologically or cytologically proven IIIB and IV NSCLC. * No symptomatic uncontrolled brain metastasis * Not suitable for platinum containing regimens if chemo-naive * Performance status less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) Scale. * Creatinine Clearance (CrCl) greater than or equal to 45 milliliters per min (mL/min) Exclusion Criteria * Prior radiation to greater than 25% of bone marrow * Inability to interrupt Aspirin at doses of greater than 1.3 grams/day or non-steroidal anti-inflammatory agents for a 5-day period. * Presence of clinically relevant third-space fluid collections not controllable. * Significant cardiac disease
References
Publications (0)
Data not yet available