Clinical trial · Interventional
Study to Access Safety of Durvalumab in Indian Adult Patients With Locally Advanced NSCLC
A Prospective, Multicenter, Phase-IV Clinical Trial to Assess Safety of Durvalumab in Indian Adult Patients With Locally Advanced, Unresectable Non-small Cell Lung Cancer (NSCLC)
NCT04416633CI-TRIAL-00082398completedPhase 4Results postedClinicalTrials.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)
A prospective, multicenter, Phase-IV clinical trial to assess safety of Durvalumab in Indian adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC)
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 |
|---|---|---|---|
| Unresectable Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Durvalumab
- description
- Single arm, Durvalumab , IV
- interventionNames
- Drug: Durvalumab
Primary outcomes (2)
- measure
- Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
- timeFrame
- Evaluation Phase (Day 1 to 141) to Follow-up Phase (90 days after End of Evaluation Visit [Day 141])
- description
- The number and proportion of participants who experienced AEs, SAEs, and AESIs, including interstitial lung disease/pneumonitis-like events and on-study deaths are presented.
- measure
- Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
- timeFrame
- Evaluation Phase (Day 1 to 141) to Follow-up Phase (90 days after End of Evaluation Visit [Day 141])
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provision of signed, written and dated informed consent prior to any study specific Procedures 2. Male or female aged 18 years or older 3. As per local prescribing information and in view of positive benefit-risk assessment, patient prescribed Durvalumab treatment as per independent clinical judgment of treating physician for either Exclusion Criteria: 1. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study 2. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the chemoradiation therapy for locally advanced NSCLC is allowed. 3. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody including durvalumab. 4. For NSCLC cohort only: 1. Mixed small cell and non-small cell lung cancer histology 2. Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy. 3. Patients with ≥Grade 2 pneumonitis from prior chemoradiation therapy 5. Active or prior documented autoimmune disease within the past 2 years, inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), primary immunodeficiency, organ transplant that requires therapeutic immunosuppression, hypersensitivity to study drug or any excipient, leptomeningeal carcinomatosis, tuberculosis. NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded. 6. Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control 7. Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results.
References
Publications (0)
Data not yet available
No reference posted for this study.