Clinical trial NCT04416633: Study to Access Safety of Durvalumab in Indian Adult Patients With Locally Advanced NSCLC
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Unresectable Non-small Cell Lung Cancer (NSCLC)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2020-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility criteria: 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

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:

   1. Mixed small cell and non-small cell lung cancer histology
   2. Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy.
   3. 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.

Primary outcomes:
measure: Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
timeFrame: Evaluation Phase (Day 1 to 141) to Follow-up Phase (90 days after End of Evaluation Visit [Day 141])
measure: Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
timeFrame: Evaluation Phase (Day 1 to 141) to Follow-up Phase (90 days after End of Evaluation Visit [Day 141])
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Delhi
country: India
facility: Research Site
city: Delhi
country: India
facility: Research Site
city: Faridabad
country: India
facility: Research Site
city: Gurgaon
country: India
facility: Research Site
city: Kolkata
country: India
facility: Research Site
city: Mohali
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
Study officials:
References: