Ages Eligible for Study: | 18 Years
to 99 Years |
Genders Eligible for Study: | Both |
Gender Based: | No |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- At least 18 years of age at the time of signing the informed consent form.
- Patient must have histologically or cytologically confirmed metastatic or locally advanced and recurrent NSCLC which is progressing.
- Patients eligible for second- or later-line therapy, who must have received an antiPD1/PD-L1 containing therapy and a platinum-doublet regimen for locally advanced or metastatic NSCLC either separately or in combination. Prior durvalumab is acceptable. The patient must have had disease progression on a prior line of antiPD1/PD-L1 therapy.
- ECOG/WHO performance status of 0 to 1, and a minimum life expectancy of 12 weeks.
- Patient must have at least 1 lesion that can be accurately measured. A previously irradiated lesion can be considered a target lesion if the lesion has clearly progressed.
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.
Exclusion Criteria:
- Patients whose tumour samples have targetable alterations in EGFR and/or ALK at initial diagnosis are excluded. In addition, patients whose tumour samples are known to have targetable alterations in ROS1, BRAF, MET or RET, are to be excluded.
- Active or prior documented autoimmune or inflammatory disorders.
- Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies).
- Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not willing to employ effective birth control.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients, or history of severe hypersensitivity reactions to other monoclonal antibodies.
- Patient has spinal cord compression or symptomatic brain metastases.
- Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Patients may receive treatment with bisphosphonates or receptor activator of nuclear factor kappa-Β ligand (RANKL) inhibitors for the treatment of bone metastases.
-history of active primary immunodeficiency
Contacts
Contact:
AstraZeneca Clinical
Study Information Center
| 1-877-240-9479
| [email protected]
| |
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator:
| John
Heymach
, M.D, Ph.D |
| The University of Texas MD Anderson Cancer Center |
Locations
Country | Location | Facility | Contact | Status | AT | Research Site | Innsbruck,
AT,
6020 | | Recruiting |
AT | Research Site | Salzburg,
AT,
5020 | | Recruiting |
AT | Research Site | Wien,
AT,
1210 | | Recruiting |
AT | Research Site | Wien,
AT,
1140 | | Recruiting |
CA
, ON | Research Site | Brampton,
ON,
CA,
L2P 2V3 | | Recruiting |
CA
, ON | Research Site | Ottawa,
ON,
CA,
K1H 8L6 | | Recruiting |
CA
, ON | Research Site | Toronto,
ON,
CA,
M5G 2M9 | | Recruiting |
KR | Research Site | Seoul,
KR,
135-710 | | Recruiting |
KR | Research Site | Seoul,
KR,
03080 | | Recruiting |
KR | Research Site | Seoul,
KR,
05505 | | Recruiting |
CA
, AB | Research Site | Edmonton,
AB,
CA,
T6G 1Z2 | | Recruiting |
CA
, QC | Research Site | Montreal,
QC,
CA,
H2X 3E4 | | Recruiting |
US
, MD | Research Site | Baltimore,
MD,
US,
21224 | | Recruiting |
US
, MD | Research Site | Baltimore,
MD,
US,
21287 | | Recruiting |
US
, CA | Research Site | Duarte,
CA,
US,
91010 | | Recruiting |
US
, CA | Research Site | Fullerton,
CA,
US,
92835 | | Recruiting |
US
, CA | Research Site | La Jolla,
CA,
US,
92093 | | Recruiting |
US
, CA | Research Site | Los Angeles,
CA,
US,
90095 | | Recruiting |
US
, MO | Research Site | Saint Louis,
MO,
US,
63110 | | Completed |
US
, MA | Research Site | Boston,
MA,
US,
02215 | | Recruiting |
US
, MA | Research Site | Boston,
MA,
US,
02215 | | Terminated |
US
, PA | Research Site | Philadelphia,
PA,
US,
19111 | | Completed |
US
, PA | Research Site | Pittsburgh,
PA,
US,
15232 | | Recruiting |
US
, TN | Research Site | Nashville,
TN,
US,
37203 | | Recruiting |
US
, TN | Research Site | Nashville,
TN,
US,
37212 | | Terminated |
IL | Research Site | Haifa,
IL,
31096 | | Completed |
IL | Research Site | Kfar Saba,
IL,
95847 | | Completed |
IL | Research Site | Petah Tikva,
IL,
49100 | | Completed |
IL | Research Site | Ramat Gan,
IL,
5265601 | | Completed |
US
, NY | Research Site | New York,
NY,
US,
10032 | | Completed |
FR | Research Site | Bordeaux,
FR,
33076 | | Recruiting |
FR | Research Site | Nantes Cedex 1,
FR,
44093 | | Recruiting |
FR | Research Site | Paris,
FR,
75877 | | Recruiting |
FR | Research Site | Villejuif,
FR,
94800 | | Recruiting |
US
, TX | Research Site | Houston,
TX,
US,
77030 | | Recruiting |
US
, DC | Research Site | Washington,
DC,
US,
20016 | | Recruiting |
US
, VA | Research Site | Fairfax,
VA,
US,
22031 | | Recruiting |
US
, MN | Research Site | Minneapolis,
MN,
US,
55455 | | Withdrawn |
US
, IL | Research Site | Chicago,
IL,
US,
60637 | | Recruiting |
DE | Research Site | Berlin,
DE,
12203 | | Recruiting |
DE | Research Site | Esslingen a.N.,
DE,
73730 | | Recruiting |
DE | Research Site | Großhansdorf,
DE,
22927 | | Recruiting |
DE | Research Site | Heidelberg,
DE,
69126 | | Recruiting |
DE | Research Site | Köln,
DE,
50924 | | Terminated |
ES | Research Site | Barcelona,
ES,
08036 | | Recruiting |
ES | Research Site | Madrid,
ES,
28034 | | Recruiting |
ES | Research Site | Madrid,
ES,
28007 | | Recruiting |
ES | Research Site | Sevilla,
ES,
41009 | | Recruiting |
US
, MI | Research Site | Detroit,
MI,
US,
48201 | | Withdrawn |
.