However, the approval is subjected to conditions that the study Principal Investigator (Medical Oncologist) and his team should have Radiotherapy expert as co-investigator or subinvestigator at each site.
Furthermore, The committee also suggested that randomization stratification should be worked out for those subjects included in the trial, who medically have resectable oesophageal squamous cell carcinoma (ESCC), however refused surgery (inclusion criteria 5).
This came after the firm presented the proposed Phase III trial protocol no. D910SC000001, Ver:2.0 dated 16Nov2021 (KUNLUN) before the committee.
Durvalumab is an Anti-PD-L1 monoclonal antibody. Durvalumab is used to treat urothelial cancers that are locally advanced or metastatic in patients who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Durvalumab is used for patients with unresectable stage III non-small-cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
At the recent SEC meeting for Oncology and Haematology held on 26th May 2022, the expert panel reviewed the proposal to conduct the phase III clinical trial of the anti-neoplastic drug Durvalumab.
After detailed deliberation, the committee recommended for grant of permission to conduct the clinical trial with the condition that:
1)The study Principal Investigator (Medical Oncologist) and his team should have a Radiotherapy expert as a co-investigator or sub-investigator at each site.
2) The committee also suggested that randomization stratification should be worked out for those subjects included in the trial, who medically have resectable oesophageal squamous cell carcinoma (ESCC), however, refused surgery (inclusion criteria 5).
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