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

NCT07760519 — Not yet recruiting, 78 participants, AstraZeneca

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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)

Registry	NCT07760519
Status	Not yet recruiting
Study type	Observational
Enrollment	78 (Estimated)
Sponsor	AstraZeneca (Industry)
Conditions	Carcinoma, Non-Small-Cell Lung
Interventions	IMFINZI (Other)
Dates	start 2026-09-30 (estimated), primary completion 2030-04-30 (estimated), completion 2030-04-30 (estimated), first posted 2026-08-12, last updated 2026-08-12

-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.

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+Arms and interventions

IMFINZI (Other): IMFINZI

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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.