A Multicenter Observational PMS Study Assessing Durvalumab Safety in Indian Adults With Resectable NSCLC

A Prospective, Observational, Multicenter, Post Marketing Surveillance Study to Assess Safety of Durvalumab in Indian Adult Patients With Resectable Non-Small Cell Lung Cancer (NSCLC)

This will be a single-arm, multicenter, prospective, observational, real-world study and the data source is the patients' medical record at each site. A total of 78 patients will be enrolled in the study.

Study Overview

• Status: Not yet recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Other: IMFINZI

• Study Type: Observational
• Enrollment (Estimated): 78

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Indian patients with previously untreated resectable (tumors ≥ 4 cm and/or node positive) NSCLC and with no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements will be enrolled from a geographically representative population from clinics/ hospitals across the country. Resectable NSCLC patients whose treatment decision with Durvalumab has been made by their treating physician and meet the eligibility criteria will be invited to participate in the study.

Description

Inclusion Criteria:

1. Patients with newly diagnosed previously untreated resectable NSCLC (tumors ≥ 4 cm and/or node positive) and no known EGFR mutations or ALK rearrangements prescribed with durvalumab as per local prescriber information.
2. Provision of signed, written and dated informed consent

Exclusion Criteria:

1. Presence of unresectable or metastatic disease.
2. Prior treatment with durvalumab for any other indications
3. Requires concurrent treatment for cancers other than resectable NSCLC
4. Concurrently participating in any other clinical trial
5. Patients with active or prior autoimmune disease or with medical conditions that required systemic corticosteroids or immunosuppressants
6. Any condition that, in the opinion of the investigator, would interfere with the patient's participation in the study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and proportion of patients with Grade 3/4 possibly related adverse events (PRAEs)*	- Frequency and proportion of patients with Grade 3/4 possibly related adverse events (PRAEs)*	21 months
Frequency and proportion of patients with treatment emergent adverse events (TEAE) & serious adverse events (SAEs), , mortality.	Frequency and proportion of patients with treatment emergent adverse events (TEAE) & serious adverse events (SAEs), , mortality.	21 months
Time to occurrence of first AEs and first SAEs	Time to occurrence of first AEs and first SAEs	21 months
* PRAEs as assessed per the WHO-UMC criteria	* PRAEs as assessed per the WHO-UMC criteria	21 months

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: August 10, 2026
• First Posted (Actual): August 12, 2026

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; Observational; Durvalumab; Indian; Real-world; post marketing surveillance
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; durvalumab
• Other Study ID Numbers: D9106R00007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No