Clinical trial · Interventional
Phase I Imaging Study Evaluating Gem/Cis or Gem/Carbo for Participants With Non-Small Cell Lung Cancer (MK-0000-083 AM3)
A Multicenter Phase Ib Trial to Measure [18F]-Fluorodeoxyglucose Uptake by Positron Emission Tomography in Stage IIIB and IV Non-Small Cell Lung Cancer Before and After Chemotherapy With Gemcitabine and Cisplatin or Carboplatin
NCT00599755CI-TRIAL-00031178completedPhase 1Results postedClinicalTrials.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 study will use imaging to look at tumor response to combination chemotherapy of gemcitabine (Gem) and cisplatin (Cis) or gemcitabine and carboplatin (Carbo) in non small cell lung cancer (NSCLC).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparator: CT or MRI and FDG-PET | Radiation | — | UNRESOLVED |
| Gemcitabine and Cisplatin or Gemcitabine and Carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gem/Cis or Gem/Carbo
- interventionNames
- Radiation: Comparator: CT or MRI and FDG-PET
- Drug: Gemcitabine and Cisplatin or Gemcitabine and Carboplatin
Primary outcomes (1)
- measure
- Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean
- timeFrame
- Weeks 3 and 6 following chemotherapy
- description
- Metabolic response conversion rate is the number of participants initially classified as non-metabolic responders relative to baseline at week 3 after starting chemotherapy, who are then, relative to week 3, reclassified as metabolic responders at week 6 after starting chemotherapy, based on a pre-specified threshold of a 20% decrease in mean standardized uptake value (SUVmean) of \[18F\]-Fluorodeoxyglucose (FDG). The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Has histologically or cytopathologically confirmed metastatic or locally advanced stage IIIB/IV Non-small cell lung cancer (NSCLC) * Has measurable disease * Has not been previously treated with surgery (involving the thorax), radiation (unless it was for a metastatic site), or chemotherapy for NSCLC * Is 18 years of age or older * Has a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale * Women of childbearing potential have a negative pregnancy test Exclusion Criteria: * Is participating in or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the start of treatment * Has untreated brain metastases related to their NSCLC or carcinomatous meningitis * Abuses drugs or alcohol * Is pregnant or breastfeeding * Is Human Immunodeficiency Virus (HIV) positive * Has active viral hepatitis * Has hearing loss * Has poorly controlled diabetes mellitus * Is allergic to gemcitabine, cisplatin or carboplatin
References
Publications (0)
Data not yet available
No reference posted for this study.