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

Not Yet RecruitingN/A

Sponsor: AstraZeneca

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: IMFINZI

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.