Lung Cancer Clinical Trial
Study of Durvalumab Following Radiation Therapy in Patients With Stage 3 Unresectable NSCLC Ineligible for Chemotherapy
This is a Phase II open-label, single-arm, multicenter, international study to evaluate the clinical activity of durvalumab in patients with Stage III unresectable NSCLC who are deemed to be ineligible for chemotherapy per Investigator assessment. Patients will be enrolled into 2 cohorts according to radiotherapy pretreatment dose (Cohort A: standard radiation therapy [60 gray (Gy) ± 10% or hypofractionated bioequivalent dose (BED)]; Cohort B: palliative radiation therapy [40 to < 54 Gy or hypofractionated BED])
This is a Phase II open-label, single-arm, multicenter, international study to evaluate the clinical activity of durvalumab in patients with Stage III unresectable NSCLC who have an Eastern Cooperative Oncology Group (ECOG) PS of 0 to 2 and who were treated with radiotherapy but are ineligible for chemotherapy. Patients will be enrolled into 2 cohorts according to the dose of radiotherapy received prior to study entry (Cohort A: Standard Radiotherapy [60 Gy ± 10% or hypofractionated BED]; Cohort B: Palliative Radiotherapy [40 to < 54 Gy or hypofractionated BED]). Patients must not have progressed following radiation therapy, and radiation therapy must be completed within 6 weeks (42 days) prior to first study drug administration. The last dose of radiation therapy is defined as the day of the last radiation treatment session. All patients will receive 1500 mg durvalumab via IV infusion every 4 weeks (q4w) for up to a maximum of 12 months (up to 13 doses/cycles)
Capable of giving signed informed consent.
Age ≥ 18 years at study entry.
Histologically or cytologically documented NSCLC with locally-advanced, unresectable Stage III disease.
Deemed ineligible for chemotherapy per Investigator assessment.
Receipt of radiation therapy that was completed within 42 days prior to first study drug administration.
Must have received a total dose of radiation of 40 to 66 Gy (standard or hypofractionated BED).
Must not have progressed following radiation therapy, as per Investigator assessed RECIST 1.1 criteria: a) Patients with measurable disease and/or nonmeasurable and/or no evidence of disease assessed at baseline by computed tomography /magnetic resonance imaging will be eligible for this study. b) Prior irradiated lesions may be considered measurable and selected as target lesions (TLs) providing they fulfill the other criteria for measurability.
World Health Organization/ECOG performance status of ≤2.
No prior exposure to immune-mediated therapy including, but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1, and antiprogrammed cell death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.
Patients must have adequate organ and marrow function as defined below:
Hemoglobin ≥ 9.0 g/dL
Absolute neutrophil count ≥ 1.0 × 109 /L
Platelet count ≥ 75 × 109/L
Serum bilirubin ≤ 1.5 × the upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome.
Alanine aminotransferase and aspartate aminotransferase ≤ 2.5 × ULN
Measured creatinine clearance > 30 mL/min or calculated CL > 30 mL/min as determined by Cockcroft-Gault
Life expectancy of greater than 12 weeks.
Body weight greater than 30 kg at study entry and at first study drug administration
Patients with locally-advanced NSCLC whose disease has progressed following radiation therapy.
Mixed small cell lung cancer and NSCLC histology.
History of allogeneic organ transplantation.
Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome).
Uncontrolled intercurrent illness (e.g., ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris)
History of another primary malignancy except for (a) malignancy treated with curative intent and with no known active disease ≥ 5 years before the first study drug administration, (b) adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease, and c) treated carcinoma in situ without evidence of disease.
History of leptomeningeal carcinomatosis
History of active primary immunodeficiency
Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus
Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, lymphopenia, and the laboratory values defined in the inclusion criteria
Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab
Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of durvalumab.
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
Participation in another clinical study with an IP administered in the last 4 weeks.
Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study or during the follow-up period of an interventional study
Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment
Patients who refuse chemotherapy by their own decision.
Involvement in the planning and/or conduct of the study
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control.
Judgment by the Investigator that the patient should not participate in the study
Genetics research study (optional):
Exclusion criteria for participation in the optional genetics research component of the study include: a) Previous allogeneic bone marrow transplant b)Nonleukocyte-depleted whole blood transfusion within 120 days of genetic sample collection.
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There are 53 Locations for this study
Tucson Arizona, 85704, United States
Tampa Florida, 33612, United States
Royal Oak Michigan, 48073, United States
Tacoma Washington, 98405, United States
Bayonne , 64100, France
Limoges , 87000, France
Lyon Cedex 08 , 69373, France
Marseille , 13009, France
Montpellier , 34070, France
Nimes , 30029, France
Rouen , 76031, France
Vantoux , 57070, France
Ancona , 60126, Italy
Brescia , 25100, Italy
Firenze , 50134, Italy
Genova , 16132, Italy
Meldola , 47014, Italy
Messina , 98158, Italy
Modena , 41124, Italy
Monza , 20900, Italy
Negrar , 37024, Italy
Pavia , 27100, Italy
Pisa , 56124, Italy
Ravenna , 48121, Italy
Roma , 00128, Italy
Białystok , 15-04, Poland
Gdańsk , 80-21, Poland
Koszalin , 75-58, Poland
Olsztyn , 10-22, Poland
Skorzewo , 60-18, Poland
Szczecin , 71-73, Poland
Warszawa , 02-78, Poland
Wroclaw , 53-41, Poland
Barnaul , 65604, Russian Federation
Kazan , 42002, Russian Federation
Nizhny Novgorod , 60308, Russian Federation
Orenburg , 46002, Russian Federation
St. Petersburg , 19700, Russian Federation
St. Petersburg , 19775, Russian Federation
St.Petersburg , 19101, Russian Federation
Ufa , 45005, Russian Federation
Yaroslavl , 15005, Russian Federation
A Coruña , 15006, Spain
Barcelona , 8035, Spain
Castello de la Plana , 12002, Spain
Madrid , 28007, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Oviedo , 33011, Spain
Pamplona , 31008, Spain
Sabadell(Barcelona) , 08208, Spain
Sevilla , 41013, Spain
Valencia , 46015, Spain
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