Roche Asked to Revise Tecentriq SC Phase IV Trial Plan for Lung Cancer in India
New Delhi: The Subject Expert Committee (SEC), functional under the CDSCO, has directed Roche Products (India) Private Limited to recalculate the sample size and submit a revised Phase IV clinical trial protocol for Atezolizumab injection 1875 mg/15 mL (Protocol No. ML46561 Version 1.0 dated December 9, 2025), thereby deferring approval of the proposed study.
The firm had proposed a Phase IV, open-label, multicohort study to evaluate the safety and efficacy of subcutaneous Atezolizumab (Tecentriq SC) in Indian adult patients with non-small cell lung cancer (NSCLC).
The study was intended to generate post-marketing clinical data to further assess the drug’s safety and effectiveness in real-world clinical settings in India.
However, upon detailed review, the committee identified concerns regarding the statistical assumptions used for determining the sample size.
Accordingly, the SEC advised the company to revise the sample size calculations using appropriate statistical methodology and resubmit the updated protocol to CDSCO for further evaluation.
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