Clinical trial · Interventional
Neoadjuvant Chemo for Non-metastatic Non-small Cell Lung Cancer
Neoadjuvant Chemotherapy for Non-metastatic Non-small Cell Lung Cancer
NCT01860040CI-TRIAL-00031572terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accrual, no data to analyze
Summary
Brief summary (as posted)
To determine the rate of pathologic complete responses (pCR) at the time of definitive surgical resection of 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 |
|---|---|---|---|
| Non-squamous Cell Non-Metastatic Non-Small Cell Lung Cancer | — | UNRESOLVED | — |
| Squamous Cell Non-Metastatic Non-Small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cisplatin and pemetrexed
- description
- Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles
- interventionNames
- Drug: Cisplatin
- Drug: Pemetrexed
- type
- EXPERIMENTAL
- label
- Cisplatin and gemcitabine
- description
- Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles
- interventionNames
- Drug: Cisplatin
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Rate of Pathologic Complete Responses (pCR) at the Time of Definitive Surgical Resection of Non-small Cell Lung Cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients ≥ 18 years of age with either a mass suspicious for or histologically confirmed AJCC stage IB-IIIA NSCLC. For those without histologic confirmation of NSCLC, a biopsy will be done and only those patients with histologically confirmed NSCLC meeting all other eligibility criteria may proceed on protocol. 2. Mass must be determined to be surgically resectable 3. Eastern Cooperative Oncology Group (ECOG) performance status score \< 1 and a life expectancy \>3 months. 4. Participants must have at least one evaluable lesion as defined by RECIST 1.1 5. Absolute neutrophil count \> 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5 g/dL 6. Serum creatinine ≤1.3 mg/dL (candidate for cisplatin chemotherapy), total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 5 times the upper limit of normal range 7. No prior chemotherapy or radiotherapy for NSCLC 8. At least 5 years from diagnosis of another cancer except treated in-situ disease or surgically resected non-melanoma skin cancer with clear margins. 9. Willingness to provide permission to biopsy NSCLC for collection of frozen pretreatment sample. 10. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial Exclusion Criteria: 1. Active clinically serious infection \> CTCAE (version 4.03) Grade 2. 2. Serious non-healing wound, ulcer, or bone fracture. 3. Major contraindication to surgical resection of NSCLC 4. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements. 5. Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements. 6. Patients receiving any other investigational agents. 7. Pregnant or lactating females
References
Publications (0)
Data not yet available
No reference posted for this study.