NCT05128630
Recruiting
Phase 2
An Open-label, Multi-center, Phase 2 Study of Chemo-immunotherapy Followed by Reduced-dose Hypo-fractionated RT and Maintenance Immunotherapy for Stage III Unresectable Non -Small-cell Lung Carcinoma (NSCLC).
Fondazione IRCCS Policlinico San Matteo di Pavia1 site in 1 country45 target enrollmentStarted: October 28, 2021Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Safety
Overview
Brief Summary
Aim of this phase 2 study is to evaluate the safety and the efficacy of the combination of induction chemotherapy plus durvalumab followed by reduced-dose hypo-fractionated thoracic RT (concurrent with durvalumab) and durvalumab maintenance for stage 3 unresectable NSCLC patients candidate to sequential chemo-RT.
Detailed Description
The study hypothesis is that the new regimen tested in this study will be safe and effective by:
- anticipating the use of durvalumab, together with chemotherapy (higher efficacy)
- harnessing response to induction chemo-durvalumab (which is expected to be significant) to be able to reduce radiotherapy dose without reducing tumor control probability
- reducing radiation-induced immunosuppression
- reducing radiation-induced late morbidity, this aspect is important when considering that this regimen is expected to be able to cure a proportion of patients (long-term survivors)
In this phase II study, the investigators will evaluate the combination of induction chemotherapy plus durvalumab followed by reduced-dose hypo-fractionated thoracic RT (concurrent with durvalumab) and durvalumab maintenance for stage 3 unresectable NSCLC patients candidate to sequential chemo-RT.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- •Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses.
- •18 years or older at the time of signing the ICF. Type of patient and disease characteristics
- •Histologically- or cytologically-documented NSCLC with locally-advanced, unresectable Stage III disease (according to the IASLC Staging Manual Version 8 \[IASLC 2016\]). Positron emission tomography (PET)/CT, MRI of the brain, and endobronchial ultrasound with biopsy are highly encouraged at diagnosis.
- •Patients with measurable disease assessed at baseline by CT/MRI will be entered in this study.
- •Must have a life expectancy of at least 12 weeks at enrolment.
- •WHO/ECOG PS 0-
- •Patient not eligible for concurrent chemo radiation according to investigator assessment
- •Adequate organ and marrow function at enrollment as defined below. These parameters should be achieved without augmentation by growth factors, transfusions, or infusions within 28 days of screening unless required for SoC:
- •Haemoglobin ≥9.0 g/dL;
Exclusion Criteria
- •Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- •Patients who have disease considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumors.
- •Mixed small-cell lung cancer and NSCLC histology.
- •History of allogeneic organ transplantation.
- •Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
- •Patients with vitiligo or alopecia.
- •Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement.
- •Any chronic skin condition that does not require systemic therapy.
- •Patients without active disease in the last 5 years at enrolment may be included but only after consultation with the Study Physician.
- •Patients with celiac disease controlled by diet alone.
Arms & Interventions
Single-arm
Experimental
Chemotherapy plus durvalumab, hypofractionated RT plus durvalumab, durvalumab maintenance
Intervention: Durvalumab (Drug)
Outcomes
Primary Outcomes
Safety
Time Frame: Within 6 months from study enrollment
Incidence of Grade 3 or more possibly related adverse events (PRAEs)
Secondary Outcomes
- Overall Survival(0-36 months from study enrollment)
- Progression-Free Survival(0-36 months from study enrollment)
Investigators
Andrea Riccardo Filippi
prof.
Fondazione IRCCS Policlinico San Matteo di Pavia
Study Sites (1)
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