Unresectable Non-small Cell Lung Cancer (NSCLC)
Conditions
Brief summary
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)
Interventions
DRUGDurvalumab
500-mg/120-mg IV
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Evaluation Phase (Day 1 to 141) to Follow-up Phase (90 days after End of Evaluation Visit [Day 141]) | 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. |
| Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Evaluation Phase (Day 1 to 141) to Follow-up Phase (90 days after End of Evaluation Visit [Day 141]) | The number of events of AEs, SAEs, and AESIs, including interstitial lung disease/pneumonitis-like events and on-study deaths are presented. |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Durvalumab Durvalumab administered intravenously for over 60 minutes at 10 mg/kg every 2 weeks.
The treatment period for this study was 20 weeks, which corresponded to 10 doses of study drug administration. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | AE greater than Grade 3 related to study drug | 1 |
| Overall Study | Death | 1 |
| Overall Study | Disease progression as per investigator's clinical and imaging assessment | 17 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Durvalumab |
|---|---|
| Age, Continuous | 62.04 Years STANDARD_DEVIATION 10.26 |
| Height | 164.44 centimeters STANDARD_DEVIATION 9.04 |
| Race/Ethnicity, Customized INDIAN | 100 Participants |
| Race/Ethnicity, Customized OTHER | 0 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 82 Participants |
| Weight | 61.12 kilograms STANDARD_DEVIATION 11.69 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 100 |
| other Total, other adverse events | 69 / 100 |
| serious Total, serious adverse events | 21 / 100 |
Outcome results
Primary
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])
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Safety Population | Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Any Adverse Event | 74 Participants |
| Safety Population | Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Any Serious Adverse Event | 21 Participants |
| Safety Population | Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Any Treatment Emergent Adverse Event | 74 Participants |
| Safety Population | Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Any Serious Treatment Emergent Adverse Event | 21 Participants |
| Safety Population | Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Treatment Emergent Adverse Event related to IMP | 26 Participants |
| Safety Population | Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Treatment Emergent Adverse Event leading to IMP discontinuation | 13 Participants |
| Safety Population | Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Treatment Emergent Adverse Event leading to Death | 4 Participants |
| Safety Population | Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Adverse events of special interest | 8 Participants |
Primary
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])
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Safety Population | Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Any Adverse Event | 267 events |
| Safety Population | Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Any Serious Adverse Event | 27 events |
| Safety Population | Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Any Treatment Emergent Adverse Event | 250 events |
| Safety Population | Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Any Serious Treatment Emergent Adverse Event | 27 events |
| Safety Population | Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Treatment Emergent Adverse Event related to IMP | 55 events |
| Safety Population | Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Treatment Emergent Adverse Event leading to IMP discontinuation | 24 events |
| Safety Population | Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Treatment Emergent Adverse Event leading to Death | 4 events |
| Safety Population | Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) | Adverse events of special interest | 8 events |