NSCLCPhase 2SILK BMNCT03955198
A Trial Evaluating Stereotactic Radiotherapy Plus Durvalumab Continuation for Patients With NSCLC Metachronous Oligometastatic Disease Under Durvalumab Consolidation Following Chemoradiation
A Phase 2 study testing Radiotherapy + durvalumab in people with NSCLC, run by Institut Claudius Regaud at 8 sites in France.
Trial summary
This study is a single-arm phase II, multicenter study designed to evaluate the activity of stereotactic radiotherapy plus the continuation of durvalumab for 12 more months for patients presenting with NSCLC metachronous oligometastatic disease during post-chemoradiotherapy durvalumab consolidation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Radiotherapy + durvalumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 8 sitesFrance
- Study dates
- 27 May 2021to 26 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Under durvalumab consolidation following chemoradiotherapy (sequential or concurrent) for previous stage III NSCLC ; patients must have received at least one infusion of durvaluamb consolidation and should be within 12 months of the first infusion ; the last infusion should have been performed within the last 28 days
- While receiving durvalumab, patients must not have experienced ≥Grade 3 immune related adverse event. Patients with endocrine AE of ≤Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic. Patients must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE
- No history of previous metastatic disease
- Stage IV metastatic disease
- Patients with 1 to 5 metastases in total, in no more than 3 organs (including brain) documented on the basis of contrast-enhanced CT-scanner of the chest, abdomen and pelvis, 18FDG-PET and brain MRI (and liver MRI in case of liver metastases)
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- All metastatic lesions are less of 4 cm in greater diameter
- For patients with brain metastases : surgery of one or several brain lesion(s) is allowed before enrollment provided that there is at least one associated non-resected lesion (cranial or extra-cranial)
- All lesions are amenable to SRT in terms of dose constraints to the organs at risk, with no prior radiotherapy interfering with SRT
- No local relapse (in-field) or regional mediastinal relapses associated
- Patient with wild type EGFR and ALK
- Age ≥ 18 years at time of study entry
- ECOG performance status < 2 i.e. 0 or 1
- Body weight >30kg
- Life expectancy of at least 3 months
- Adequate Hematology laboratory data within 6 weeks prior to start of treatment: Absolute neutrophils> 1.5 x 109/L, Platelets ≥ 100 x 109/L, Hemoglobin ≥ 9 g/dL
- Adequate Biochemistry laboratory data within 6 weeks prior to start of treatment: Total bilirubin ≤ 1.5 x ULN (except patient with confirmed Gilbert's syndrome or liver metastasis: Total bilirubin ≤ 3 X ULN), Transaminases ≤ 2.5 x ULN, Alkalin phosphatases ≤ 5 x ULN, Creatinine clearance > 40 mL/min (Cockcroft)
- Women should be post-menopaused or willing to accept the use an effective contraceptive regimen during the treatment period and at least 3 months after the end of the study treatment. All non-menopaused women should have a negative pregnancy test within 72 hours prior to registration. Men should accept to use an effective contraception during treatment period and at least 3 months after the end of the study treatment
- Patient 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
- Signed written informed consent
- Patient affiliated to a Social Health Insurance in France
Who cannot join
- Cancer histology other than NSCLC
- Local relapse or mediastinal relapse associated to oligometastatic relapse following chemoradiation
- Prior radiotherapy near the metastatic lesions precluding ablative SRT
- Contraindication to SRT of a lesion due to organ dysfunction; in particular, patients with lung lesions and documented or suspected interstitial lung disease should not be included
- Metastatic spinal cord compression
- Brain metastases in the brainstem
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- Known leptomeningeal metastases
- Patient unable to have MRI for any reason (e.g., due to pacemaker, ferromagnetic implants, claustrophobia, extreme obesity)
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician
- Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician
- Participation in another therapeutic trial within the 30 days prior to entering this study (participation in a survival follow-up period of a clinical study is not an exclusion criterion)
- Prior therapy with an anti-PD-1, anti-PD-L1 (except during durvalumab consolidation), anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
- Current or prior use of immunosuppressive medication within 7 days before the first fraction of RT; however the use of corticosteroids at any dose for the management of an AE or a compressive progressive lesion is allowed
- Active suspected or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, diverticulitis with the exception of diverticulosis, systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). Note: participants with vitiligo or alopecia, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, patients with celiac disease controlled by diet alone, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger, are permitted to enroll
- Known primary immunodeficiency or active HIV (positive HIV 1/2 antibodies)
- Known active or chronic viral hepatitis or history of any type of hepatitis within the last 6 months indicated by positive test for hepatitis B surface antigen (HBV sAG) or hepatitis C virus ribonucleic acid (HCV antibody)
- History of active tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice)
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- History of severe allergic reactions to any unknown allergens or any components of the study drug
- History of allogenic organ transplantation
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP
- 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 90 days after the last dose of durvalumab
- Patient who has forfeited his/her freedom or who is under legal protection (curatorship and guardianship, protection of justice)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Institut de Cancérologie de Bourgogne - Auxerre
Auxerre
Institut Sainte-Catherine
Avignon
Centre François Baclesse
Caen
Centre Georges-Francois Leclerc
Dijon
Centre Hospitalier Universitaire Lyon Sud
Lyon
Centre Henri Becquerel
Rouen
CHP Saint Grégoire
Saint-Grégoire
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse
About this study
Official title: A Multicentric Phase II Trial of Stereotactic Radiotherapy Plus Durvalumab Continuation for Patients With NSCLC Metachronous Oligometastatic Disease Under Durvalumab Consolidation Following Chemoradiation
This study is a single-arm phase II, multicenter study designed to evaluate the activity of stereotactic radiotherapy plus the continuation of durvalumab for 12 more months for patients presenting with NSCLC metachronous oligometastatic disease during post-chemoradiotherapy durvalumab consolidation.
Fifty patients will have to be enrolled in this phase II trial.
Total duration of treatment will be 12 months.
Patients will be followed for a maximum of 2 years following the date of inclusion.
- Conditions
- NSCLC
- Being tested
- Radiotherapy + durvalumab
- Keywords
- NSCLC, Anti-PD-L1, Durvalumab, Stereotactic Radiation therapy, Oligometastatic disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy + durvalumabCombination product
Radiotherapy will be administered in combination with Durvalumab
| Study group | Role | What they receive |
|---|---|---|
| Patients with NSCLC metachronous oligometastatic disease | Experimental | Not described Receives: Combination Product: Radiotherapy + durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival defined as the time from inclusion to disease progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Measured: 24 months for each patient
Secondary outcomes (3)
Immune progression-free survival defined as the time from inclusion to disease progression (per iRECIST) or death from any cause, whichever occurs first.
Measured: 24 months for each patient
Safety will be assessed by the toxicity grading of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v 5.0).
Measured: 24 months for each patient
Quality of life will be evaluated using the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30).
Measured: 24 months for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start27 May 2021
- Primary completion26 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955198
- Sponsor's protocol ID
- 18POUM06
- Acronym
- SILK BM
- Status last verified
- Sep 2024
- First submitted
- 16 May 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric Phase II Trial of Stereotactic Radiotherapy Plus Durvalumab Continuation for Patients With NSCLC Metachronous Oligometastatic Disease Under Durvalumab Consolidation Following Chemoradiation
- ClinicalTrials.gov ID
- NCT03955198
- Acronym / sponsor ID
- SILK BM / 18POUM06
- Conditions
- NSCLC
- Keywords
- NSCLC, Anti-PD-L1, Durvalumab, Stereotactic Radiation therapy, Oligometastatic disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-arm phase II, multicenter study designed to evaluate the activity of stereotactic radiotherapy plus the continuation of durvalumab for 12 more months for patients presenting with NSCLC metachronous oligometastatic disease during post-chemoradiotherapy durvalumab consolidation.
Fifty patients will have to be enrolled in this phase II trial.
Total duration of treatment will be 12 months.
Patients will be followed for a maximum of 2 years following the date of inclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with NSCLC metachronous oligometastatic disease | Experimental | Combination Product: Radiotherapy + durvalumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Under durvalumab consolidation following chemoradiotherapy (sequential or concurrent) for previous stage III NSCLC ; patients must have received at least one infusion of durvaluamb consolidation and should be within 12 months of the first infusion ; the last infusion should have been performed within the last 28 days
- While receiving durvalumab, patients must not have experienced ≥Grade 3 immune related adverse event. Patients with endocrine AE of ≤Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic. Patients must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE
- No history of previous metastatic disease
- Stage IV metastatic disease
Key exclusion criteria (28 listed)
- Cancer histology other than NSCLC
- Local relapse or mediastinal relapse associated to oligometastatic relapse following chemoradiation
- Prior radiotherapy near the metastatic lesions precluding ablative SRT
- Contraindication to SRT of a lesion due to organ dysfunction; in particular, patients with lung lesions and documented or suspected interstitial lung disease should not be included
- Metastatic spinal cord compression
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 |
|---|---|---|
| Radiotherapy + durvalumabRadiotherapy will be administered in combination with Durvalumab | Combination product | Patients with NSCLC metachronous oligometastatic disease |
Primary outcome
Progression-free survival defined as the time from inclusion to disease progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Time frame: 24 months for each patient
3 secondary outcomes
Immune progression-free survival defined as the time from inclusion to disease progression (per iRECIST) or death from any cause, whichever occurs first.
Time frame: 24 months for each patient
Safety will be assessed by the toxicity grading of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v 5.0).
Time frame: 24 months for each patient
Quality of life will be evaluated using the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30).
Time frame: 24 months for each patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 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 Radiotherapy + durvalumab in people with NSCLC, run by Institut Claudius Regaud at 8 sites in France.
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 21 inclusion and 28 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 defined as the time from inclusion to disease progression (per RECIST v1.1) or death from any cause, whichever occurs first. (time frame: 24 months for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.