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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
500-mg/120-mg IV
Research Site
Bangalore, India
Research Site
Bangalore, India
Research Site
Delhi, India
Research Site
Delhi, India
Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
The number and proportion of participants who experienced AEs, SAEs, and AESIs, including interstitial lung disease/pneumonitis-like events and on-study deaths are presented.
Time frame: Evaluation Phase (Day 1 to 141) to Follow-up Phase (90 days after End of Evaluation Visit [Day 141])
Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
The number of events of AEs, SAEs, and AESIs, including interstitial lung disease/pneumonitis-like events and on-study deaths are presented.
Time frame: Evaluation Phase (Day 1 to 141) to Follow-up Phase (90 days after End of Evaluation Visit [Day 141])
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Research Site
Faridabad, India
Research Site
Gurgaon, India
Research Site
Kolkata, India
Research Site
Mohali, India
Research Site
Mumbai, India
Research Site
Mumbai, India
...and 2 more locations