Clinical trial · Interventional
Consolidation Chemotherapy/Concurrent Chemo-radiotherapy for Inoperable Stage III Non-small Cell Lung Cancer (NSCLC)
A Pilot Study: Phase II Study of Histology-based Consolidation Chemotherapy Following Concurrent Chemo-radiotherapy for Inoperable Stage III 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): Low accrual, small patient population at center.
Summary
Brief summary (as posted)
This is a pilot phase II study of histology based consolidation chemotherapy in patients with inoperable stage III Non-Small Cell Lung Cancer (NSCLC) following concurrent chemo-radiotherapy. Patients with inoperable stage III NSCLC would be treated with standard concurrent chemo-radiotherapy and subsequently those with non-squamous histology would be offered 4 cycles of consolidation pemetrexed and those with squamous histology 4 cycles of consolidation with gemcitabine.
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 |
|---|---|---|---|
| Stage III Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy following concurrent Chemoradiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Active Treatment
- description
- ACTIVE TREATMENT intervention below: 1. NSCLC (Non-Small Cell Lung Cancer) 2. PE (Cisplatin 50mg/m2 on days 1,8,29,36 Etoposide 60 mg/m2 days 1-3 and 29-31) 3. Radiation 59.4 Gy with 2 cycles of PE 4. (Non-squamous histology) Pemetrexed consolidation 500mg/m2 every 21 days for 4 cycles 5. (Squamous histology) Gemcitabine consolidation 1000mg/m2 days 1,8, every 21 days for 4 cycles
- interventionNames
- Drug: Chemotherapy following concurrent Chemoradiotherapy
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- 3 years
- description
- From date of registration to date of first observation of progressive disease, death due to any cause or symptomatic deterioration.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult patients 18 years and older with histology proven NSCLC with inoperable stage III A or IIIB disease. 2. Inoperable stage III A defined by multiple and or/bulky N2 mediastinal lymph nodes on computed tomography (CT) scan such that in opinion of treating investigator, the patient was not a candidate for surgical resection. 3. N2 disease must be documented by either biopsy, fluorodeoxyglucose positron emission tomography (PET), and or CT scan if nodes are more than 2 cm. 4. Stage IIIB patients must have N3 or T4 status. N3 status must be documented by presence of contralateral (to the primary tumor) mediastinal lymph node or supraclavicular or scalene lymph node proven by either biopsy, fluorodeoxyglucose PET, or more than 2 cm on CT scan. 5. No prior treatment for lung cancer 6. ECOG Performance status of 0-1. 7. Initiation of consolidation chemotherapy within 4-8 weeks of concurrent chemo-radiotherapy without progression. 8. Adequate organ function * leukocytes \>3,000/mcL * absolute neutrophil count \>1,500/mcL * platelets \>100,000/mcL * total bilirubin within normal institutional limits * AST (SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal * creatinine within normal institutional limits OR * creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal All labs should be obtained within 14 days prior to start of study drug treatment. 9. Ability to give informed consent and willingness to adhere to study protocol. Exclusion Criteria: 1. Patient who have had prior treatment for lung cancer. 2. Prior history of radiation to chest. 3. Known malignancy other than the current cancer. 4. Uncontrolled intercurrent illness including but not limited to ongoing active infection, history of cardiac disease, e.g. uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within last six months or ventricular arrhythmias requiring medication, psychiatric illness that would impair patients ability to comply with study requirements. 5. Pregnant or lactating women (any women becoming pregnant during the study will be withdrawn from the study) 6. Patient with documented or symptoms of peripheral neuropathy. 7. History of allergic reaction to compounds similar to the ones used in this study. 8. Malignant effusions (pleural or pericardial) 9. Superior sulcus (Pancoast) tumors. 10. Any condition that would hamper ability to give informed consent or ability to comply with study protocol. 11. HIV patients on anti-retroviral therapy are in-eligible to participate in this study because of potential interaction with the study drugs and increase susceptibility for infections during course of marrow suppressive chemotherapy and radiotherapy.
References
Publications (0)
Data not yet available