Clinical trial · Interventional
FDG-PET/CT Scans in Patients With Stage IIIB or Stage IV NSCLC Undergoing Chemotherapy
[18F]FDG-PET/CT as a Predictive Marker of Tumor Response and Patient Outcome: Prospective Validation in 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
Why stopped (as posted): Recruitment obstacles; data to be combined with other resources for analysis
Summary
Brief summary (as posted)
RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18 (\^18FDG) positron emission tomography (PET)/CT scans, may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This clinical trial is studying \^18FDG PET/CT scans to see how well they predict response in patients undergoing chemotherapy for stage IIIB or stage IV non-small cell lung cancer.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FDG | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group A - 3 FDG-PET/CT Scans
- description
- Two FDG-PET/CT scans prior to 1st cycle of chemotherapy, plus 2 optional volumetric CT scans. One FDG-PET/CT after 1st cycle of chemotherapy, plus 1 optional volumetric CT scan.
- interventionNames
- Radiation: FDG
- type
- EXPERIMENTAL
- label
- Group B - 2 FDG-PET/CT + 1 Optional
- description
- One FDG-PET/CT prior to 1st cycle of chemotherapy; 1 FDG-PET/CT after the 1st cycle of chemotherapy; 1 optional FDG-PET/CT after the 2nd cycle of chemotherapy. All three with optional volumetric CT scans.
- interventionNames
- Radiation: FDG
- type
- EXPERIMENTAL
- label
- Group C - Test-Retest
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer
* Newly diagnosed stage IIIB (with malignant pleural effusion) or stage IV disease (Group I and II), or newly diagnosed stage IIIA, IIIB, or IV (Group III) determined by all of the following:
* CT scan or MRI of the chest and upper abdomen (including liver and adrenal glands) within the past 4 weeks
* History/physical examination within the past 6 weeks
* CT scan or MRI of the brain within the past 4 weeks, if there is headache, mental/physical impairment, or other signs or symptoms suggesting brain metastases within the past 2 months
* No small cell carcinoma
* No pure bronchioloalveolar carcinoma
* Patients with recurrent or metastatic disease are eligible provided they meet 1 of the following criteria:
* Received surgery or radiotherapy for treatment of the primary tumor and locoregional disease ≥ 3 months prior to study entry AND have a measurable lesion in the chest
* Received chemotherapy in the adjuvant setting or as part of combined modality therapy for locoregional disease ≥ 3 months prior to recurrent or metastatic disease diagnosis AND have a measurable lesion in the chest
* Measurable disease, defined as at least 1 measurable primary tumor or other intrathoracic/supraclavicular lesion ≥ 2 cm
* Scheduled to be treated with a platinum-based dual-agent chemotherapy regimen administered at 3-week intervals with or without bevacizumab or cetuximab (Group I and II)
* Scheduled to be treated with standard chemotherapy in the current protocol, other standard chemotherapy, experimental chemotherapy, or other treatment including no treatment (Group III)
* No symptomatic brain metastases (Groups I and II only)
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2 (Groups I and II only)
* Group III may include potential participants regardless of ECOG performance status score
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to tolerate positron emission tomography (PET)/CT scanning
* No contraindication to chemotherapy and PET/CT scanning, as demonstrated by laboratory testing
* No poorly controlled diabetes (i.e., fasting glucose level \> 150 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications
* No prior malignancy other than basal cell or squamous cell carcinoma of the skin, carcinoma in situ, or other cancer from which the patient has been disease free for ≥ 3 years (Groups I and II)
* Prior malignancy is not an exclusion factor for Group III
* No clinical or radiographic signs of post-obstructive pneumonia
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 3 months since prior thoracic radiotherapy, lung surgery, or chemotherapy
* Prior chemotherapy in the adjuvant setting or as part of a combined modality regimen for locoregional disease that was given ≥ 3 months prior to diagnosis of recurrent or metastatic disease allowed
* No planned treatment with any targeted biologic therapy including gefitinib or erlotinib hydrochloride (Group I and II)
* No concurrent chemoradiotherapy
* No concurrent bevacizumabReferences
Publications (0)
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