A Study Evaluating The Combination of Immunotherapy With Radiotherapy in Non-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago
About this trial
Current clinical trials testing the combination of immunotherapy with radiotherapy.
Eligibility criteria
Qualifiers
Disease-Related Criteria
Patients must have histologically or cytologically confirmed metastatic or recurrent non-small cell lung cancer (NSCLC) with progression on prior immunotherapy
The patient's disease is eligible for SOC treatment with immunotherapy or chemotherapy.
Patients must have measurable disease per RECIST v1.1, defined as at least one lesion that can be accurately measured in at least one dimension with longest diameter ≥10 mm (or ≥15 mm short axis for lymph nodes) by CT or MRI
Disqualifiers
Patients with history of (non-infectious) pneumonitis requiring corticosteroids.
Patients with evidence of interstitial lung disease.
Patients with uncontrolled intercurrent illness.
Pregnant women are excluded from this study. Radiation is considered Class X and chemotherapy such as docetaxel are considered Class D agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with radiation, immunotherapy, and chemotherapy breastfeeding should be discontinued if the mother is participating in the study.
Trial design
Treatments tested in this trial
- Investigator Choice Immunotherapy (for example: pembrolizumab, cemiplimab, durvalumab, ipilimumab plus nivolumab)
- Investigator Choice Chemotherapy (for example docetaxel with or without ramucirumab, gemcitabine, or other National Comprehensive Cancer Network (NCCN)-recommended treatments)
- Ablative Hypofractionated Radiotherapy
Treatment groups
39 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov