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.
Condition or disease | Intervention/treatment | Phase |
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NSCLC | Combination Product: Radiotherapy + durvalumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | May 27, 2021 |
Estimated Primary Completion Date : | December 2025 |
Estimated Study Completion Date : | December 2025 |
Arm | Intervention/treatment |
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Experimental: Patients with NSCLC metachronous oligometastatic disease |
Combination Product: Radiotherapy + durvalumab
Radiotherapy will be administered in combination with Durvalumab
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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
History of another primary malignancy except for:
Contact: Elizabeth COHEN-JONATHAN MOYAL | +33 5 31 15 99 07 | moyal.elizabeth@iuct-oncopole.fr | |
Contact: Jonathan KHALIFA | +33 5 31 15 54 29 | khalifa.jonathan@iuct-oncopole.fr |
France | |
Centre Hospitalier Universitaire | Not yet recruiting |
Lyon, France | |
Contact: Françoise MORNEX +33 4 78 86 42 53 francoise.mornex@chu-lyon.fr | |
Institut Cancerologie de L'Ouest | Not yet recruiting |
Saint-Herblain, France | |
Contact: François THILLAYS +33 240 679 929 françois.thillays@ico.unicancer.fr | |
Institut Universitaire du Cancer Toulouse - Oncopole | Recruiting |
Toulouse, France | |
Contact: Elizabeth Cohen-Jonathan Moyal +33 5 31 15 99 07 moyal.elizabeth@iuct-oncopole.fr |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 16, 2019 | ||||||||
First Posted Date ICMJE | May 20, 2019 | ||||||||
Last Update Posted Date | June 9, 2021 | ||||||||
Actual Study Start Date ICMJE | May 27, 2021 | ||||||||
Estimated Primary Completion Date | December 2025 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
Original Primary Outcome Measures ICMJE |
Time to intra-cranial progression according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria [ Time Frame: 24 months for each patient ] | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A Trial Evaluating Stereotactic Radiotherapy Plus Durvalumab Continuation for Patients With NSCLC Metachronous Oligometastatic Disease Under Durvalumab Consolidation Following Chemoradiation | ||||||||
Official Title ICMJE | A Multicentric Phase II Trial of Stereotactic Radiotherapy Plus Durvalumab Continuation for Patients With NSCLC Metachronous Oligometastatic Disease Under Durvalumab Consolidation Following Chemoradiation | ||||||||
Brief 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. 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. |
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Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | NSCLC | ||||||||
Intervention ICMJE | Combination Product: Radiotherapy + durvalumab
Radiotherapy will be administered in combination with Durvalumab
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Study Arms ICMJE | Experimental: Patients with NSCLC metachronous oligometastatic disease
Intervention: Combination Product: Radiotherapy + durvalumab
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
50 | ||||||||
Original Estimated Enrollment ICMJE |
100 | ||||||||
Estimated Study Completion Date ICMJE | December 2025 | ||||||||
Estimated Primary Completion Date | December 2025 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03955198 | ||||||||
Other Study ID Numbers ICMJE | 18POUM06 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Institut Claudius Regaud | ||||||||
Study Sponsor ICMJE | Institut Claudius Regaud | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Institut Claudius Regaud | ||||||||
Verification Date | June 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |