Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Durvalumab: 3 weekly cycle, IV infusion till PD
Control Intervention1: NOT APPLICABLE: NOT APPLICABLE
Sponsors
AstraZeneca AB
AstraZeneca Pharma India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: General inclusion criteria for all patients: 1. Patient must be 18 years or older, at the time of signing the ICF. For subjects aged 2. Patient received durvalumab monotherapy and/or durvalumab containing combination in an AstraZeneca/MedImmune-sponsored parent clinical study that is approved for enrollment into this study. 3. Patients who received durvalumab in combination with any other approved or investigational anticancer agents in the parent clinical study must have completed or discontinued all other anticancer therapy (beyond durvalumab regimen). 4. Patient must be willing and able to provide written informed consent and to comply with scheduled visits and other study procedures. Additional inclusion criteria for patients entering Cohort 1: 5. Currently receiving durvalumab monotherapy (this includes patients enrolled in durvalumab combinations who have completed or discontinued all other anticancer therapy combined with durvalumab in the parent clinical study, and are now receiving durvalumab monotherapy), and is currently benefiting from treatment with durvalumab therapy, as determined by the Investigator. Additional inclusion criteria for patients entering Cohort 1 and Cohort 2: 6. Adequate organ function 7. Evidence of postmenopausal status or negative urinary or serum pregnancy test for female premenopausal patients. 8. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of Additional inclusion criteria for retreatment patients in Cohort 2 9. Received durvalumab in a parent clinical study that is approved to enroll into this study. 10. Completed the defined treatment duration with durvalumab monotherapy or durvalumab combination therapy in the parent clinical study, as defined below: a. Previously benefited from treatment with durvalumab monotherapy or durvalumab combination therapy, as determined by the Investigator. b. Has not previously received retreatment with durvalumab monotherapy. c. Maintained SD or better (Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]) throughout the period of defined treatment duration, and has not received any subsequent anticancer therapy. 11. At least 1 lesion that can be accurately measured at baseline
Exclusion criteria
Exclusion criteria: Patients must not enter the study if any of the following key exclusion criteria are fulfilled: 1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). Additional exclusion criteria for Cohort 1 and Cohort 2: 2. Currently receiving treatment in another interventional clinical study other than a parent clinical study, or received treatment during the follow-up period before retreatment (Cohort 2 only). 3. Experienced an immune-mediated or non-immune-mediated (hematologic and non-hematologic) toxicity that led to permanent discontinuation of durvalumab in the parent clinical study 4. Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade >=2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. 5. Prior treatment with immunotherapy other than durvalumab, or any other approved or investigational anticancer agents other than MedImmune/AstraZeneca s investigational immunotherapy molecules administered in the parent clinical study. 6. Any concurrent chemotherapy, investigational product (IP), biologic or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable. 7. Active or prior documented autoimmune or inflammatory disorders. 8. History of allogenic organ transplantation. 9. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active ILD, serious chronic GI conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent. 10. Documented active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B virus (HBV) (known positive HBV surface antigen [HbsAg] result), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HbsAg) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Prior HIV and HBV/HCV testing from the parent clinical study is acceptable documentation and patients will not need to undergo an additional testing prior to Cohort 1 enrollment in this study. For Cohort 2 patients, prior HIV testing from the parent clinical study is acceptable documentation and patients will not need to undergo an additional test prior to retreatment. However, patients will require retesting for HbsAg and HCV within the 28-day window prior to retreatment. 11. Receipt of live attenuated vaccine within 30 days prior to the first dose of study drug in the present study. Note: Patients, if enrolled, should not receive live vaccine while receiving study drug and up to 90 days after the last dose of study drug. 12. Female patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To monitor long-term safety of durvalumab (all cohorts)Timepoint: It will be assessed every 6 weeks till PD | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the efficacy of durvalumab in terms of ORR and DOR in patients who undergo retreatment with durvalumab (Cohort 2 only)Timepoint: 1. ORR: Number (%) of patients with a confirmed response of CR or PR. 2. DOR: Time from first documented CR or PR to time of first documented disease progression or death in the absence of disease progression ;To assess the OS of patients (all cohorts)Timepoint: OS: Time from date of randomization/enrollment in the parent clinical study until the date of death by any cause | — |
Countries
Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Netherlands, Poland, Republic of Korea, Romania, Russian Federation, Serbia, Spain, Swaziland, Taiwan, Thailand, Ukraine, United Kingdom, United States of America, Viet Nam
Contacts
Public ContactBalaji B R
IQVIA RDS (India) Private Limited
Outcome results
None listed