A Phase 4 interventional study of Durvalumab in Unresectable Non-small Cell Lung Cancer (NSCLC), sponsored by AstraZeneca. Completed at 12 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment
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)
AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
For NSCLC cohort only:
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.
Single arm, Durvalumab , IV
Drug: Durvalumab
500-mg/120-mg IV
Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
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.
Time frame: Evaluation Phase (Day 1 to 141) to Follow-up Phase (90 days after End of Evaluation Visit [Day 141])
Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)
The number of events of AEs, SAEs, and AESIs, including interstitial lung disease/pneumonitis-like events and on-study deaths are presented.
Time frame: Evaluation Phase (Day 1 to 141) to Follow-up Phase (90 days after End of Evaluation Visit [Day 141])
| Milestone | Durvalumab |
|---|---|
| Started | 100 |
| Completed | 69 |
| Not completed | 31 |
| Withdrew: Death | 1 |
| Withdrew: Disease progression as per investigator's clinical and imaging assessment | 17 |
| Withdrew: Ae greater than grade 3 related to study drug | 1 |
| Withdrew: Adverse event | 6 |
| Withdrew: Withdrawal by subject | 6 |
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.
| Participants | Safety Population |
|---|---|
| Any Adverse Event | 74 |
| Any Serious Adverse Event | 21 |
| Any Treatment Emergent Adverse Event | 74 |
| Any Serious Treatment Emergent Adverse Event | 21 |
| Treatment Emergent Adverse Event related to IMP | 26 |
| Treatment Emergent Adverse Event leading to IMP discontinuation | 13 |
| Treatment Emergent Adverse Event leading to Death | 4 |
| Adverse events of special interest | 8 |
The number of events of AEs, SAEs, and AESIs, including interstitial lung disease/pneumonitis-like events and on-study deaths are presented.
| events | Safety Population |
|---|---|
| Any Adverse Event | 267 |
| Any Serious Adverse Event | 27 |
| Any Treatment Emergent Adverse Event | 250 |
| Any Serious Treatment Emergent Adverse Event | 27 |
| Treatment Emergent Adverse Event related to IMP | 55 |
| Treatment Emergent Adverse Event leading to IMP discontinuation | 24 |
| Treatment Emergent Adverse Event leading to Death | 4 |
| Adverse events of special interest | 8 |
Collected over Day 1 to Day 230 of the Follow-up Period (ie, up to 8 months).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Durvalumab | 4/100 (4%) | 21/100 (21%) | 69/100 (69%) |
| Event | Durvalumab |
|---|---|
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 5/100 |
| DeathGeneral disorders | 2/100 |
| PyrexiaGeneral disorders | 2/100 |
| PneumoniaInfections and infestations | 2/100 |
| FatigueGeneral disorders | 1/100 |
| PainGeneral disorders | 1/100 |
| Hepatobiliary diseaseHepatobiliary disorders | 1/100 |
| Respiratory tract infectionInfections and infestations | 1/100 |
| SepsisInfections and infestations | 1/100 |
| Urinary tract infectionInfections and infestations | 1/100 |
| Event | Durvalumab |
|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 20/100 |
| PyrexiaGeneral disorders | 19/100 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 13/100 |
| HypothyroidismEndocrine disorders | 12/100 |
| Amylase increasedInvestigations | 6/100 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 6/100 |
| DiarrhoeaGastrointestinal disorders | 5/100 |
| AstheniaGeneral disorders | 5/100 |
| ConstipationGastrointestinal disorders | 4/100 |
| Chest painGeneral disorders | 4/100 |
Enrolled analysis set
| Age, Continuous(Years) | Durvalumab |
|---|---|
| Mean | 62.04 ± 10.26 |
| Sex: Female, Male(Participants) | Durvalumab |
|---|---|
| Female | 18 |
| Male | 82 |
| Race/Ethnicity, Customized(Participants) | Durvalumab |
|---|---|
| INDIAN | 100 |
| OTHER | 0 |
| Height(centimeters) | Durvalumab |
|---|---|
| Mean | 164.44 ± 9.04 |
| Weight(kilograms) | Durvalumab |
|---|---|
| Mean | 61.12 ± 11.69 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Durvalumab