Study to Access Safety of Durvalumab in Indian Adult Patients With Locally Advanced, NSCLC

Study Overview
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Brief Summary
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A prospective, multicenter, Phase-IV clinical trial to assess safety of Durvalumab in Indian adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) and urothelial cancer

Official Title
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A Prospective, Multicenter, Phase-IV Clinical Trial to Assess Safety of Durvalumab in Indian Adult Patients With Locally Advanced, Unresectable Non-small Cell Lung Cancer (NSCLC)

Conditions
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Unresectable Non-small Cell Lung Cancer (NSCLC) and Urothelial Cancer

Intervention / Treatment
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* Drug: Durvalumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed, written and dated informed consent prior to any study specific Procedures Male or female aged 18 years or older As per local prescribing information and in view of positive benefit-risk assessment, patient prescribed Durvalumab treatment as per independent clinical judgment of treating physician for either Exclusion Criteria: Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug, 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. Systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the chemoradiation therapy for locally advanced NSCLC is allowed. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody including durvalumab. For NSCLC cohort only: Mixed small cell and non-small cell lung cancer histology Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy. Patients with ≥Grade 2 pneumonitis from prior chemoradiation therapy Active or prior documented autoimmune disease within the past 2 years, inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), primary immunodeficiency, organ transplant that requires therapeutic immunosuppression, hypersensitivity to study drug or any excipient, leptomeningeal carcinomatosis, tuberculosis. NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded. Female patients 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 the study drug or interpretation of patient safety or study results.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Durvalumab<br>Single arm, Durvalumab , IV | Drug: Durvalumab<br>* 500-mg/120-mg IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of durvalumab among locally advanced unresectable non-small cell lung carcinoma and metastatic urothelial carcinoma | Number, frequency and proportion of patients with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) including interstitial lung disease/pneumonitis-like events, and on-study deaths. | 12 Months |