Clinical trial · Observational
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)
NCT07760519CI-TRIAL-00121639not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMFINZI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Frequency and proportion of patients with Grade 3/4 possibly related adverse events (PRAEs)*
- timeFrame
- 21 months
- description
- \- Frequency and proportion of patients with Grade 3/4 possibly related adverse events (PRAEs)\*
- measure
- Frequency and proportion of patients with treatment emergent adverse events (TEAE) & serious adverse events (SAEs), , mortality.
- timeFrame
- 21 months
- description
- Frequency and proportion of patients with treatment emergent adverse events (TEAE) \& serious adverse events (SAEs), , mortality.
- measure
- Time to occurrence of first AEs and first SAEs
- timeFrame
- 21 months
- description
- Time to occurrence of first AEs and first SAEs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.