Study to check safety of Durvalumab in Indian patients with non-small cell lung cancer

Phase 4

Active, not recruiting

• Conditions: Health Condition 1: C33- Malignant neoplasm of trachea

• Registration Number: CTRI/2020/08/027287
• Lead Sponsor: AstraZeneca Pharma India Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Provision of signed, written and dated informed consent prior to any study specific Procedures

2.Male or female aged 18 years or older

3.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 a. treatment for locally advanced, unresectable non-small cell lung carcinoma whose disease has not progressed following platinum-based chemoradiation therapy b treatment for locally advanced or metastatic urothelial carcinoma whose disease has progressed during or after platinum-based chemotherapy.

Exclusion Criteria

1 Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study

2.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.

3.Prior exposure to any anti-PD-1 or anti-PD-L1 antibody including durvalumab.

4.For NSCLC cohort only:

a.Mixed small cell and non-small cell lung cancer histology

b.Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy.

c.Patients with =Grade 2 pneumonitis from prior chemoradiation therapy

5.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.

6.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

7.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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the safety of durvalumab among locally advanced unresectable non-small cell lung carcinoma and metastatic urothelial carcinoma in Indian patientsTimepoint: 20 Weeks

Secondary Outcome Measures

Name	Time	Method
nilTimepoint: nil