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)

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07760519

Enrollment

Registered

2026-08-12

Start date

2026-09-30

Completion date

2030-04-30

Last updated

2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Durvalumab, NSCLC, post marketing surveillance, Real-world, Observational, Indian

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.

Interventions

OTHERIMFINZI

IMFINZI

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Contacts

CONTACTAstraZeneca Clinical Study Information Center

information.center@astrazeneca.com1-877-240-9479

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026