Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Non -Small Cell Lung Cancer
  • Oligoprogressive
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Primary Objective: To compare overall survival (OS) from the time of the time of randomization between the treatment and control groups. Secondary Objective(s) To compare the extra-CNS PFS2 (EC-PFS2), defined as the time to extracranial disease progression on second line systemic therapy or death fr...

Primary Objective: To compare overall survival (OS) from the time of the time of randomization between the treatment and control groups. Secondary Objective(s) To compare the extra-CNS PFS2 (EC-PFS2), defined as the time to extracranial disease progression on second line systemic therapy or death from the first day of local consolidative radiation therapy (treatment group) or from the start of second line therapy (control group). To evaluate time to initiation of second line systemic therapy or palliative care after completion of local consolidative therapy in the treatment group To compare the toxicities in the treatment and control groups; To compare overall progression free survival from the time of the first day of local consolidative radiation therapy for the treatment group and from the start of second line therapy for the control group To compare the pattern of next progression on second line therapy in the treatment group vs the control group. To evaluate local progression in lesions treated with local consolidative radiation therapy.

Tracking Information

NCT #
NCT04485026
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Michael Farris, MD Wake Forest University Health Sciences