Study ID: NRC LU002
Maintenance chemotherapy with or without stereotactic body radiation therapy in treating patients with stage 4 non-small cell lung cancer
This study seeks to determine how well giving maintenance chemotherapy with or without stereotactic body radiation therapy (SBRT) works in treating patients with stage 4 non-small cell lung cancer (NSCLC). SBRT is a specialized therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. The researchers are trying to discern if maintenance chemotherapy and SBRT together work better than maintenance chemotherapy alone in treating patients with stage 4 NSCLC.
There are two arms to this study. Participants assigned to Arm 1 will receive maintenance chemotherapy. Those in Arm 2 will receive SBRT and maintenance chemotherapy.
- Pathologically proven diagnosis of NSCLC, with metastases (stage IV disease) present prior to registration; this includes patients newly diagnosed with metastatic disease or those initially diagnosed and treated for stage I-III NSCLC who ultimately develop metastases
- Patients must have received first-line/induction chemotherapy (4 cycles) and achieved stable disease or a partial response. Prior systemic chemotherapy as part of concurrent treatment approach for previously diagnosed stage III NSCLC, as adjuvant therapy for previously resected NSCLC, or for other previous cancers is permitted
- Prior radiotherapy for patients with brain metastases prior to enrollment is acceptable. Patients must have measurable disease at baseline and three or fewer discrete, extracranial metastatic disease sites that are technically amenable to SBRT
- For de novo stage IV NSCLC patients (patients with metastatic disease at first presentation), primary disease must be treatable with local therapy in the form of SBRT or hypofractionated radiation; if the primary disease is found in the peripheral or central lung parenchyma without nodal disease for instance, SBRT may be employed; if primary disease is more advanced with involvement of the mediastinum (T4 tumor, N1-N3 disease, etc.), these volumes should be technically treatable with hypofractionated radiation
- If primary disease in the thoracic cavity was previously treated with local therapy in the form of surgery, any local/regional disease recurrence should be technically treatable with SBRT or hypofractionated radiation after induction systemic therapy
- Patients with brain metastases are eligible if these lesions have been previously treated and the patients have no clinical or radiographic evidence of progression prior to enrollment
*See protocol for complete list of inclusion/exclusion criteria
- Arm 1: maintenance chemotherapy. Patients may receive docetaxel IV over 60 minutes on day 1, or gemcitabine IV over 30 minutes on days 1 and 8. Patients with non-squamous NSCLC may receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- Arm 2: SBRT plus maintenance chemotherapy. Patients undergo SBRT over 2-4 weeks. If SBRT cannot be used to treat primary disease sites, patients also undergo IMRT or 3D-CRT over 3-5 weeks. Within 2 weeks after completion of RT, patients receive chemotherapy as in Arm 1 (docetaxel IV over 60 minutes on day 1, or gemcitabine IV over 30 minutes on days 1 and 8; patients with non-squamous non-NSCLC may receive pemetrexed disodium IV over 10 minutes on day 1).
- Must have been diagnosed with stage 4 metastatic NSCLC
- Must have already received 4 cycles of first-line/induction chemotherapy and experienced a partial response or are in stable condition