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)
1 other identifier
observational
78
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2026
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2026
CompletedFirst Posted
Study publicly available on registry
August 12, 2026
CompletedStudy Start
First participant enrolled
September 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2030
Study Completion
Last participant's last visit for all outcomes
April 30, 2030
August 12, 2026
August 1, 2026
3.6 years
June 17, 2026
August 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Interventions
IMFINZI
Eligibility Criteria
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.
You may qualify if:
- 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.
- Provision of signed, written and dated informed consent
You may not qualify if:
- Presence of unresectable or metastatic disease.
- Prior treatment with durvalumab for any other indications
- Requires concurrent treatment for cancers other than resectable NSCLC
- Concurrently participating in any other clinical trial
- Patients with active or prior autoimmune disease or with medical conditions that required systemic corticosteroids or immunosuppressants
- Any condition that, in the opinion of the investigator, would interfere with the patient's participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2026
First Posted
August 12, 2026
Study Start (Estimated)
September 30, 2026
Primary Completion (Estimated)
April 30, 2030
Study Completion (Estimated)
April 30, 2030
Last Updated
August 12, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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
- 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.
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.