Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07760519

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

IMFINZI

Other

IMFINZI

Primary outcomes

  1. Frequency and proportion of patients with Grade 3/4 possibly related adverse events (PRAEs)*

    Time frame: 21 months

    • Frequency and proportion of patients with Grade 3/4 possibly related adverse events (PRAEs)*

  2. Frequency and proportion of patients with treatment emergent adverse events (TEAE) & serious adverse events (SAEs), , mortality.

    Time frame: 21 months

    Frequency and proportion of patients with treatment emergent adverse events (TEAE) & serious adverse events (SAEs), , mortality.

  3. Time to occurrence of first AEs and first SAEs

    Time frame: 21 months

    Time to occurrence of first AEs and first SAEs

  4. * PRAEs as assessed per the WHO-UMC criteria

    Time frame: 21 months

    • PRAEs as assessed per the WHO-UMC criteria

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.