Status:
COMPLETED
Immunotherapy With or Without SBRT in Patients With Stage IV Non-small Cell Lung Cancer
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Lung Cancer
Stage IV Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This phase III trial studies immunotherapy and stereotactic body radiation therapy to see how well it works compared with immunotherapy alone after first-line systemic therapy (therapy that goes throu...
Detailed Description
PRIMARY OBJECTIVES: I. To compare progression-free survival of patients randomized to radiation and consolidative immunotherapy against those receiving consolidative immunotherapy alone. SECONDARY O...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients who are 18 years or older.
- Performance Status 0-2 (ECOG) at time of consult with radiation oncology.
- Pathologically proven non-small cell lung cancer (NSCLC) with evidence of metastatic disease.
- Must have received 4 cycles of standard of care systemic therapy (usually this will consist of combination chemo-immunotherapy), with a CT chest abdomen pelvis that was performed after completion of these 4 cycles and demonstrates no evidence of progression per RECIST v1.1.
- To be eligible for enrollment and randomization, patients must be within 180 days from their first dose of standard of care systemic therapy. Cycle 1 day 1 is defined as day 1. If enrolled on day 180, the patient would need to be randomized the same day.
- Persistent active disease must be amenable to radiation treatment per the treating radiation oncologist, and patients must have at least one residual site of disease which can be identified by CT or PET/CT and targeted with radiation.
- Patients who previously had earlier stage NSCLC treated definitively and have now developed new distant disease, are eligible for inclusion if they have undergone at least 4 cycles of standard of care systemic therapy for their metastatic recurrence, and they meet all criteria above.
- There are no strict size or tumor number limitations in a given organ (lung, liver, abdomen pelvis, or spine). This is at the discretion of the treating radiation oncologist.
- Exclusion Criteria from Enrollment
- More than 180 days has elapsed since day 1 of cycle 1 of standard of care systemic therapy.
- Pregnant or lactating women.
- The patient has received treatment for other carcinomas within the last three years (Except for cured non-melanoma skin cancer, low-risk prostate cancer, T1/T2 glottic cancer, stage 0 or stage I breast cancer, non-invasive bladder cancer, or treated in-situ cervical cancer). Prior lung cancer diagnosis now with oligometastatic recurrence is not an exclusion criteria.
- Patients with major activating mutations in EGFR (del19, L858R, and T790M) or ROS 1 or ALK gene rearrangements are excluded
- Eligibility for Randomization
- Once enrolled on study, patients will have a PET/MRI brain for restaging. Patients with no evidence of progression and 8 or fewer sites of active persistent disease per the treating physician are eligible for randomization.
- If a PET has been performed within 30 days of enrollment with no evidence of progression per RECIST v1.1, then this scan may be used and does not have to be repeated prior to randomization.
- If an MRI brain has been performed within 90 days of enrollment with no evidence of progression per RECIST v1.1, then this scan may be used and does not have to be repeated prior to randomization.
Exclusion
Key Trial Info
Start Date :
June 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2025
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03867175
Start Date
June 24 2019
End Date
April 21 2025
Last Update
June 13 2025
Active Locations (1)
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1
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157