Palliative Radiotherapy With Lurbinectedin in Patients With Extensive Stage Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
About this trial
This phase I trial aims to determine if it is safe to use palliative radiotherapy and lurbinectedin at the same time to treat small cell lung cancer that has spread outside of the chest and that has grown after being treated with chemotherapy (extensive stage). Lurbinectedin kills tumor cells by blocks a process called transcription that small cell lung cancer relies on to survive. It also damages the deoxyribonucleic acid (DNA) of tumor cells, which is similar to the way radiation kills tumor cells. Palliative radiotherapy is a routine medical treatment for patients who have lung cancer that has spread to other parts of the body (metastatic), and is used to relieve symptoms caused by cancer or to patients from developing symptoms. This trial may help doctors understand if treating patients with lurbinectedin and palliative radiotherapy at the same time would make them both work better than either one alone or if they could cause more side effects for patients when given together.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status =< 3
Patients with pathologically confirmed ES-SCLC who are receiving lurbinectedin or are candidates for lurbinectedin therapy after progression on first-line systemic therapy (either chemotherapy [platinum etoposide] or chemoimmunotherapy) at the discretion of the treating medical oncologist.
Metastatic bone or visceral/lung metastatic disease as assessed computed tomography (CT), magnetic resonance imaging (MRI), bone scan or positron emission tomography (PET)/CT within 90 days prior to RT on this study.
Disqualifiers
Pregnancy or breastfeeding within 2 weeks
Patients may not enroll in both safety cohorts
Spinal cord previously irradiated to > 40 Gy (delivered in =< 3Gy/fraction)
Brachial plexus previously irradiated to > 50Gy (delivered in =< 3Gy/fraction)
Trial design
Design model
Single group
Treatments tested in this trial
Lurbinectedin
DrugGiven IV
Palliative Radiation Therapy
RadiationUndergo RT
Treatment groups
22 Participants
are divided into 1 treatment groupGroup A: Treatment (lurbinectedin and palliative radiation therapy)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Incidence of adverse events of palliative radio therapy (RT) with lurbinectedin
Will be defined as having one or none of the following: * Grade 4 or 5 serious adverse events possibly, probably, or definitely related to protocol treatment from 30 days from the start of RT. * Any adverse events possibly, probably, or definitely related to protocol treatment that leads to prolonged dose delays (defined as with-holding of two consecutive doses of lurbinectedin). * Any adverse event possibly, probably, or definitely related to treatment resulting in the permanent discontinuation of lurbinectedin. Will be analyzed separately for safety cohorts 1 and 2 and will be summarized descriptively using frequencies and percentages. These will be compared to rates reported by Trigo et al. from lurbinectedin monotherapy.
Time frame
Up to 1 yearSecondary outcomes
1
The number of dose reductions or interruptions possibly, probably, or definitely due to the delivery of protocol therapy
Feasibility will be defined as the number of dose reductions or interruptions possibly, probably, or definitely due to the delivery of protocol therapy in the 30 days following completion palliative RT. Will be summarized descriptively using frequencies and percentages.
Time frame
30 days following completion palliative RT2
Response rate
Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The rate will be reported, along with a 95% confidence interval estimated using the Clopper-Pearson method.
Time frame
At 3 months post-RT3
Pain response rates
Will be assessed at 3 months post-RT, as assessed by the Brief Pain Inventory (BPI), at 3 months as well as pre-treatment (at registration). The rates will be reported, along with 95% confidence intervals estimated using the Clopper-Pearson method.
Time frame
At 3 months pre-treatment and 3 months post-RT4
Progression free survival (PFS)
Those alive without disease progression will be censored at last date of disease assessment. PFS will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median PFS will be estimated using the Brookmeyer-Crowley approach.
Time frame
From protocol treatment initiation to disease progression or death, assessed up to 1 yearOther outcomes
1
Hematologic toxicity rate
Rates of hematologic toxicity (grade 3+) as a function of dose-volume relationships of irradiated bone marrow volume will be reported, using frequencies and percentages.
Time frame
Up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Jazz Pharmaceuticals
Collaborator
Source ClinicalTrials.gov