Clinical trial · Interventional
Positron Emission Tomography in Predicting Response in Patients Who Are Undergoing Treatment With Pemetrexed Disodium and Cisplatin With or Without Surgery for Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
Early Positron Emission Tomography as a Predictor of Response in Neoadjuvant Chemotherapy for 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)
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET), (done before, during, and after chemotherapy) may help doctors predict a patient's response to treatment and help plan the best treatment. Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well PET works in predicting response in patients who are undergoing treatment with pemetrexed disodium and cisplatin with or without surgery for stage I, stage II, or stage III 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| fludeoxyglucose F 18 | Radiation | — | UNRESOLVED |
| pemetrexed disodium | Drug | Pemetrexed | ALIAS |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant therapy, PET scan and surgery
- interventionNames
- Drug: cisplatin
- Drug: pemetrexed disodium
- Procedure: adjuvant therapy
- Procedure: therapeutic conventional surgery
- Radiation: fludeoxyglucose F 18
Primary outcomes (1)
- measure
- Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy
- timeFrame
- Between days 18 and 22 prior to second chemotherapy infusion
- description
- Number of Participants with Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy
Secondary outcomes (2)
- measure
- Safety of Neoadjuvant Chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * Stage IB, II, IIIA, or IIIB (T4, N0-1) disease * Staging must have been performed 4 weeks prior to study entry with a CT scan of chest, upper abdomen, and fludeoxyglucose F 18 (\^18FDG) positron emission tomography (PET) scan * Mediastinal evaluation and staging based on combination of CT scan and FDG-PET results * If N1 or N2 nodes are found by FDG-PET or CT scan, metastases must be ruled out by brain MRI * Measurable and resectable disease * T4 lesions must be resectable * Eligible for curative surgery * No malignant pleural effusion PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,250/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 3.0 times ULN Renal * Creatinine clearance ≥ 45 mL/min Pulmonary * Adequate pulmonary reserve to undergo surgery * Predicted FEV\_1 \> 0.8 L after resection Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * Able to take corticosteroids * Able to take folic acid or vitamin B\_12 supplements * No other malignancy within the past 5 years except nonmelanoma skin cancer or noninvasive cervical cancer * No concurrent serious or uncontrolled disorder that would preclude study participation * No type I diabetes mellitus * Type II diabetes mellitus allowed if glucose is 80-150 mg/dL PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy * No concurrent prophylactic filgrastim (G-CSF) * No concurrent thrombopoiesis-stimulating agents Chemotherapy * At least 5 years since prior chemotherapy Endocrine therapy * No concurrent anticancer hormonal therapy Radiotherapy * No prior radiotherapy to the chest * No concurrent curative or palliative radiotherapy Surgery * Not specified Other * At least 30 days since prior non-FDA-approved or investigational agents * At least 5 days since prior aspirin or other nonsteroidal anti-inflammatory agents (8 days for long-acting agents \[e.g., piroxicam\]) * No other concurrent anticancer therapy * No other concurrent investigational agents
References
Publications (1)
- DERIVEDRomine PE, Martins RG, Eaton KD, Wood DE, Behnia F, Goulart BHL, Mulligan MS, Wallace SG, Kell E, Bauman JE, Patel SA, Vesselle HJ. Long term follow-up of neoadjuvant chemotherapy for non-small cell lung cancer (NSCLC) investigating early positron emission tomography (PET) scan as a predictor of outcome. BMC Cancer. 2019 Jan 14;19(1):70. doi: 10.1186/s12885-019-5284-2. PMID 30642285