Recurrent Small Cell Lung CarcinomaPhase 2NCT02701400
Tremelimumab and Durvalumab With or Without Radiation Therapy in Patients With Relapsed Small Cell Lung Cancer
A Phase 2 study testing Durvalumab, Hypofractionated Radiation Therapy and Stereotactic Body Radiation Therapy in people with Recurrent Small Cell Lung Carcinoma, run by Emory University at 2 sites in United States.
Trial summary
This randomized clinical trial studies how well tremelimumab and durvalumab with or without radiation therapy works in treating patients with small cell lung cancer that has returned after a period of improvement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Small Cell Lung Carcinoma
- What is being tested?
- Durvalumab, Hypofractionated Radiation Therapy and Stereotactic Body Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Apr 2016to 7 Aug 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent and any locally-required authorization (e.g.,) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L (≥ 1500 per mm³)
- Platelet count ≥ 100 x 10⁹/L (≥ 100,000 per mm³)
- Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); this will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
Show all 16Show fewer
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤ 5 x ULN
- Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
- Female subjects must either be of non-reproductive potential (i.e., post-menopausal by history: ≥ 60 years old and no menses for ≥ 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy upon study entry
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
- Patients must have baseline evaluations performed prior to the first dose of study drug and must meet all inclusion and exclusion criteria
- Patients must have histologically or cytologically confirmed small cell lung cancer
- Patients must have measurable disease, defined as at least one lesion (excluding the lesion for XRT) that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as > 20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT) scan
- Patient must have failed or found to be intolerant of standard frontline platinum-based regimens and must not have received > 2 prior lines of therapy (nota bene [NB]: retreatment with a platinum-based doublet for sensitive relapse counts as another line therapy; however substitution of cisplatin with carboplatin or vice versa due to toxicity does not count as a separate regimen)
- Negative serum pregnancy test within 48 hours before starting study treatment in women with childbearing potential
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Previous enrollment or randomization in the present study
- Treatment with an investigational product during the last 2 weeks
- Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab or an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4), including tremelimumab
- Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) ≤ 14 days prior to the first dose of study drug (≤ 7 days or four half-lives, whichever is longer, prior to the first dose of study drug for subjects who have received prior tyrosine kinase inhibitors [TKIs] [e.g., erlotinib, gefitinib and crizotinib] and within 6 weeks for nitrosourea or mitomycin C)
- Mean QT interval corrected for heart rate (QTc) ≥ 470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia's Correction
Show all 25Show fewer
- Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
- Any unresolved toxicity (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2) from previous anti-cancer therapy; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
- Any prior grade ≥ 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE > grade 1
- Active or prior documented autoimmune disease within the past 2 years; NOTE: subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
- Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
- History of primary immunodeficiency
- History of allogeneic organ transplant
- History of hypersensitivity to durvalumab or any excipient
- History of hypersensitivity to the combination or comparator agent
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
- Known history of previous clinical diagnosis of tuberculosis
- History of leptomeningeal carcinomatosis
- Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab or tremelimumab
- Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
- Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
- Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids
- Subjects with uncontrolled seizures
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period
- Patients receiving any other investigational agents for any reason or non-investigational agents administered for the purpose of controlling cancer growth (use of conventional external beam radiation therapy will be allowed during protocol therapy solely for palliation of localized painful lesions or bone lesions at risk of fracture provided the radiation field does not encompass any selected target lesions required for assessment)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: A Randomized Study of Tremelimumab Plus Durvalumab Combination With or Without Radiation in Relapsed Small Cell Lung Cancer
This randomized clinical trial studies how well tremelimumab and durvalumab with or without radiation therapy works in treating patients with small cell lung cancer that has returned after a period of improvement. Monoclonal antibodies, such as tremelimumab and durvalumab, may limit the ability of tumor cells to grow and spread by enhancing immune function. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving tremelimumab and durvalumab together with radiation therapy may lead to improved clinical benefit.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the efficacy (progression free survival [PFS] and objective response rate [ORR]) of combined immune checkpoint inhibitor therapy as treatment for relapsed small-cell lung cancer (SCLC).
SECONDARY OBJECTIVES:
- To assess the impact of antigen priming using radiation therapy (XRT) on the efficacy of immune checkpoint inhibitors.
II. To determine immune related objective response rate.
III. To estimate overall survival measured as time from randomization to death from any cause.
TERTIARY OBJECTIVES:
- To characterize tumor infiltrating lymphocytes (TILs) and programmed cell death 1 ligand 1 (PD-L1)/programmed cell death 1 (PD1) expression in paired tumor biopsies at baseline, end of cycle 2 and at the time of progression.
II. To determine dynamic changes in cell free deoxyribonucleic acid (DNA) (cfDNA) and the immunophenotype of peripheral blood repertoire of circulating lymphocytes using multiparameter flow cytometry.
III. To determine changes in circulating cytokine mediators of inflammation and immunity using Luminex assay.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive tremelimumab intravenously (IV) over 1 hour on day 1. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive durvalumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving disease control may restart treatment upon evidence of progressive disease, with or without confirmation.
ARM II: Patients undergo radiation therapy daily for 5 days over 1 week or for 3 fractions every other day for 1 week and then receive the same treatment as in Arm I.
After completion of study treatment, patients are followed up periodically.
- Conditions
- Recurrent Small Cell Lung Carcinoma
- Being tested
- Durvalumab, Hypofractionated Radiation Therapy, Stereotactic Body Radiation Therapy, Tremelimumab
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabBiological
Also called MEDI4736
Given IV
Hypofractionated Radiation TherapyRadiation
Also called Hypofractionated Radiotherapy, Hypofractionation
Undergo hypofractionated radiation therapy
Stereotactic Body Radiation TherapyRadiation
Also called SBRT
Undergo SBRT
TremelimumabBiological
Also called Anti-CTLA4 Human Monoclonal Antibody CP-675,206, CP-675,206, Ticilimumab
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (tremelimumab, durvalumab) | Experimental | Patients receive tremelimumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive durvalumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving disease control may restart treatment upon evidence of progressive disease, with or without confirmation. Receives: Biological: Durvalumab; Biological: Tremelimumab |
| Arm II (RT, tremelimumab, durvalumab) | Active comparator | Patients undergo stereotactic body radiation therapy (SBRT) or hypofractionated radiation therapy daily for 5 days over 1 week or for 3 fractions every other day for 1 week and then receive the same treatment as in Arm I. Receives: Biological: Durvalumab; Radiation: Hypofractionated Radiation Therapy; Radiation: Stereotactic Body Radiation Therapy; Biological: Tremelimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Time from initiation of therapy to objective disease progress or death
Measured: From initiation of systemic therapy to first documented disease progression, assessed through study completion, up to 2 years
Objective Response Rate
Disease response to therapy measured according to RECIST 1.1 criteria
Measured: After every 2 cycles of treatment (1 cycle = 4 weeks), assessed through study completion, up to 2 years
Secondary outcomes (2)
Immune-related Objective Response Rate
Disease response to treatment using immune-related response rate (irRR) criteria
Measured: Assessed after every 2 cycles (1 cycle = 4 weeks) on treatment; assessed through study completion, up to 2 years
Overall Survival
Time interval from entering the study until death
Measured: From randomization until death from any cause, assessed through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study start14 Apr 2016
- Primary completion7 Aug 2020
- Study completion7 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Taofeek K. Owonikoko, Emory University
- Investigators
- Taofeek Owonikoko, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701400
- Sponsor's protocol ID
- IRB00086004
- Other IDs
- NCI-2016-00026, ESR-14-10531, Winship3112-15
- Status last verified
- May 2021
- First submitted
- 23 Feb 2016
- Last updated
- 22 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pakkala S, Higgins K, Chen Z, Sica G, Steuer C, Zhang C, Zhang G, Wang S, Hossain MS, Nazha B, Beardslee T, Khuri FR, Curran W, Lonial S, Waller EK, Ramalingam S, Owonikoko TK. Durvalumab and tremelimumab with or without stereotactic body radiation therapy in relapsed small cell lung cancer: a randomized phase II study. J Immunother Cancer. 2020 Dec;8(2):e001302. doi: 10.1136/jitc-2020-001302.
PubMed 33428583
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Tremelimumab Plus Durvalumab Combination With or Without Radiation in Relapsed Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02701400
- Acronym / sponsor ID
- IRB00086004
- Conditions
- Recurrent Small Cell Lung Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 14 Apr 2016 (actual)
- Primary completion
- 7 Aug 2020 (actual)
- Study completion
- 7 Aug 2020 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Posted 22 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial studies how well tremelimumab and durvalumab with or without radiation therapy works in treating patients with small cell lung cancer that has returned after a period of improvement. Monoclonal antibodies, such as tremelimumab and durvalumab, may limit the ability of tumor cells to grow and spread by enhancing immune function. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving tremelimumab and durvalumab together with radiation therapy may lead to improved clinical benefit.
Detailed description
PRIMARY OBJECTIVE:
- To assess the efficacy (progression free survival [PFS] and objective response rate [ORR]) of combined immune checkpoint inhibitor therapy as treatment for relapsed small-cell lung cancer (SCLC).
SECONDARY OBJECTIVES:
- To assess the impact of antigen priming using radiation therapy (XRT) on the efficacy of immune checkpoint inhibitors.
II. To determine immune related objective response rate.
III. To estimate overall survival measured as time from randomization to death from any cause.
TERTIARY OBJECTIVES:
- To characterize tumor infiltrating lymphocytes (TILs) and programmed cell death 1 ligand 1 (PD-L1)/programmed cell death 1 (PD1) expression in paired tumor biopsies at baseline, end of cycle 2 and at the time of progression.
II. To determine dynamic changes in cell free deoxyribonucleic acid (DNA) (cfDNA) and the immunophenotype of peripheral blood repertoire of circulating lymphocytes using multiparameter flow cytometry.
III. To determine changes in circulating cytokine mediators of inflammation and immunity using Luminex assay.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive tremelimumab intravenously (IV) over 1 hour on day 1. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive durvalumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving disease control may restart treatment upon evidence of progressive disease, with or without confirmation.
ARM II: Patients undergo radiation therapy daily for 5 days over 1 week or for 3 fractions every other day for 1 week and then receive the same treatment as in Arm I.
After completion of study treatment, patients are followed up periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (tremelimumab, durvalumab) | Experimental | Biological: Durvalumab, Biological: TremelimumabPatients receive tremelimumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive durvalumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving disease control may restart treatment upon evidence of progressive disease, with or without confirmation. |
| Arm II (RT, tremelimumab, durvalumab) | Active comparator | Biological: Durvalumab, Radiation: Hypofractionated Radiation Therapy, Radiation: Stereotactic Body Radiation Therapy, Biological: TremelimumabPatients undergo stereotactic body radiation therapy (SBRT) or hypofractionated radiation therapy daily for 5 days over 1 week or for 3 fractions every other day for 1 week and then receive the same treatment as in Arm I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Written informed consent and any locally-required authorization (e.g.,) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L (≥ 1500 per mm³)
- Platelet count ≥ 100 x 10⁹/L (≥ 100,000 per mm³)
Key exclusion criteria (25 listed)
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Previous enrollment or randomization in the present study
- Treatment with an investigational product during the last 2 weeks
- Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab or an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4), including tremelimumab
- Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) ≤ 14 days prior to the first dose of study drug (≤ 7 days or four half-lives, whichever is longer, prior to the first dose of study drug for subjects who have received prior tyrosine kinase inhibitors [TKIs] [e.g., erlotinib, gefitinib and crizotinib] and within 6 weeks for nitrosourea or mitomycin C)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabAlso: MEDI4736Given IV | Biological | Arm I (tremelimumab, durvalumab), Arm II (RT, tremelimumab, durvalumab) |
| Hypofractionated Radiation TherapyAlso: Hypofractionated Radiotherapy, HypofractionationUndergo hypofractionated radiation therapy | Radiation | Arm II (RT, tremelimumab, durvalumab) |
| Stereotactic Body Radiation TherapyAlso: SBRTUndergo SBRT | Radiation | Arm II (RT, tremelimumab, durvalumab) |
| TremelimumabAlso: Anti-CTLA4 Human Monoclonal Antibody CP-675,206, CP-675,206, TicilimumabGiven IV | Biological | Arm I (tremelimumab, durvalumab), Arm II (RT, tremelimumab, durvalumab) |
Primary outcome
Progression Free Survival (PFS)
Time frame: From initiation of systemic therapy to first documented disease progression, assessed through study completion, up to 2 years
Time from initiation of therapy to objective disease progress or death
Objective Response Rate
Time frame: After every 2 cycles of treatment (1 cycle = 4 weeks), assessed through study completion, up to 2 years
Disease response to therapy measured according to RECIST 1.1 criteria
2 secondary outcomes
Immune-related Objective Response Rate
Time frame: Assessed after every 2 cycles (1 cycle = 4 weeks) on treatment; assessed through study completion, up to 2 years
Overall Survival
Time frame: From randomization until death from any cause, assessed through study completion, up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33428583Pakkala S, Higgins K, Chen Z, Sica G, Steuer C, Zhang C, Zhang G, Wang S, Hossain MS, Nazha B, Beardslee T, Khuri FR, Curran W, Lonial S, Waller EK, Ramalingam S, Owonikoko TK. Durvalumab and tremelimumab with or without stereotactic body radiation therapy in relapsed small cell lung cancer: a randomized phase II study. J Immunother Cancer. 2020 Dec;8(2):e001302. doi: 10.1136/jitc-2020-001302.
- Journal ManuscriptLink provided by the sponsor.
Related trials for Recurrent Small Cell Lung Carcinoma
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingObservational study
Patient-Specific MRD Liquid Biopsy in Resected NSCLC: Plasma and Bronchial Washing ctDNA
Non-Small Cell Lung Cancer, Minimal Residual Disease
RecruitingPhase 3
Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial
Lung Non-Small Cell Carcinoma
RecruitingPhase 3
Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer
Advanced Lung Non-Squamous Non-Small Cell Carcinoma, Metastatic Lung Non-Squamous Non-Small Cell Carcinoma
RecruitingPhase 1
A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Metastatic Solid Tumor, Recurrent Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taofeek Owonikoko, MD, PhD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab, Hypofractionated Radiation Therapy and Stereotactic Body Radiation Therapy in people with Recurrent Small Cell Lung Carcinoma, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: From initiation of systemic therapy to first documented disease progression, assessed through study completion, up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02701400, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.