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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_662 | Other Identifier | Merck |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gem/Cis or Gem/Carbo | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: CT or MRI and FDG-PET | Radiation | Participants have 4 computed tomography (CT) or magnetic resonance imaging (MRI) scans at screening, baseline, at the end of each treatment cycle (day 21 and day 42.) They also have FDG-PET scans, 2 at Baseline and one at the end of each treatment cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean | 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. | Weeks 3 and 6 following chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Repeatability of FDG SUVmean at Baseline | Two positron emission tomography (PET) scans are obtained on different days at baseline, as close together as possible, under conditions of no biological change, to measure FDG SUVmean. 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. | Between -14 to -6 days and between -5 to 0 days prior to starting chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine and Cisplatin or Gemcitabine and Carboplatin | Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Gemcitabine and Cisplatin or Gemcitabine and Carboplatin | Drug | Gemcitabine administered intravenously at a dose of 1000-1250 mg/m^2 on Day 1 and Day 8 of each cycle; Cisplatin administered intravenously at a dose of 60-85 mg/m^2 or Carboplatin at a dose of 4-6 Area Under the Curve (AUC) on Day 1 of each cycle. Two cycles are given 3 weeks apart. |
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| Change in FDG-PET Uptake From Baseline to Week 3 | Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. 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. | Baseline and Week 3 |
| Change in FDG-PET Uptake From Week 3 to Week 6 | Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. 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. | Week 3 and Week 6 |
| Change in FGD-PET Uptake From Baseline to Week 6 | Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. 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. | Baseline and Week 6 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine and Cisplatin or Gemcitabine and Carboplatin | Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean | 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. | Participants with evaluable scans classified as non-metabolic responders relative to baseline at 3 Weeks after starting chemotherapy | Posted | Number | Participants | Weeks 3 and 6 following chemotherapy |
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| Secondary | Repeatability of FDG SUVmean at Baseline | Two positron emission tomography (PET) scans are obtained on different days at baseline, as close together as possible, under conditions of no biological change, to measure FDG SUVmean. 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. | Participants who underwent two baseline PET scans | Posted | Geometric Mean | Standard Deviation | SUVmean | Between -14 to -6 days and between -5 to 0 days prior to starting chemotherapy |
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| Secondary | Change in FDG-PET Uptake From Baseline to Week 3 | Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. 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. | Participants with PET scans at baseline and 3 weeks after starting chemotherapy | Posted | Number | 90% Confidence Interval | Fold Change in SUVmean | Baseline and Week 3 |
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| Secondary | Change in FDG-PET Uptake From Week 3 to Week 6 | Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. 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. | Participants with PET scans at 3 weeks and 6 weeks after starting chemotherapy | Posted | Number | 90% Confidence Interval | Fold change in SUVmean | Week 3 and Week 6 |
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| Secondary | Change in FGD-PET Uptake From Baseline to Week 6 | Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. 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. | Participants with PET scans at baseline and 6 weeks after starting chemotherapy. | Posted | Number | 90% Confidence Interval | Fold change in SUVmean | Baseline and Week 6 |
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| Post-Hoc | Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy At a Threshold of a 30% Decrease in SUVmean | 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 30% decrease in 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. | Participants with evaluable scans classified as non-metabolic responders relative to baseline at 3 Weeks after starting chemotherapy | Posted | Number | Participants | Weeks 3 and 6 following chemotherapy |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gemcitabine and Cisplatin or Gemcitabine and Carboplatin | Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo | 24 | 68 | 61 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 14.0 |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 |
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| Angina pectoris | Cardiac disorders | MedDRA 14.0 |
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| Atrial fibrillation | Cardiac disorders | MedDRA 14.0 |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 14.0 |
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| Cardiac valve disease | Cardiac disorders | MedDRA 14.0 |
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| Myocardial infarction | Cardiac disorders | MedDRA 14.0 |
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| Dysphagia | Gastrointestinal disorders | MedDRA 14.0 |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 14.0 |
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| Disease progression | General disorders | MedDRA 14.0 |
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| Non-cardiac chest pain | General disorders | MedDRA 14.0 |
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| Pyrexia | General disorders | MedDRA 14.0 |
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| Influenza | Infections and infestations | MedDRA 14.0 |
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| Lobar pneumonia | Infections and infestations | MedDRA 14.0 |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 14.0 |
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| Lung abscess | Infections and infestations | MedDRA 14.0 |
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| Neutropenic sepsis | Infections and infestations | MedDRA 14.0 |
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| Pneumonia | Infections and infestations | MedDRA 14.0 |
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| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 14.0 |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 |
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| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 |
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| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 |
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| VIIth nerve paralysis | Nervous system disorders | MedDRA 14.0 |
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| Mediastinal mass | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 |
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| Aortic aneurysm rupture | Vascular disorders | MedDRA 14.0 |
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| Superior vena cava syndrome | Vascular disorders | MedDRA 14.0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 |
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| Constipation | Gastrointestinal disorders | MedDRA 14.0 |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.0 |
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| Asthenia | General disorders | MedDRA 14.0 |
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| Chest pain | General disorders | MedDRA 14.0 |
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| Fatigue | General disorders | MedDRA 14.0 |
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| Pyrexia | General disorders | MedDRA 14.0 |
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| Neutrophil count decreased | Investigations | MedDRA 14.0 |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 |
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| Hypokalemia | Metabolism and nutrition disorders | MedDRA 14.0 |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 |
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| Dizziness | Nervous system disorders | MedDRA 14.0 |
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| Insomnia | Psychiatric disorders | MedDRA 14.0 |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.0 |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 |
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Subsequent to multicenter publication, or 24 months after study completion, whichever comes first, an investigator and/or colleague(s) may publish the results for their study site independently. The SPONSOR recommends against this practice due to scientific concerns. The SPONSOR must have the opportunity to review all publications or presentations regarding this study 60 days prior to submission, and any information identified by the SPONSOR as confidential must be deleted prior to submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President,Global Clinical Development | Merck Sharp and Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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