PD-L1 PET/CT to predict avelumab treatment response in NSCLC

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 37

Inclusion Criteria

1. Male or female subjects aged * 18 years and >50 years in patients with
resectable stage Ia (*T1b tumor) - IIIa NSCLC
2. Histological or cytologic proven stage IIIb/IV NSCLC or resectable stage Ia
(*T1b tumor) - IIIa NSCLC
3. ECOG performance score (0-1)Karnofsky performance score * 70
4. At least one lesion with a tumor size * 1 cm
5. Hematologic function: absolute neutrophil count (ANC) * 1.5 × 109/L,
platelet count * 100 × 109/L, and hemoglobin * 9 g/dL (may have been transfused)
6. Hepatic function: total bilirubin level * 1.5 × the upper limit of normal
(ULN) range and AST and ALT levels * 2.5 × ULN for all subjects or AST and ALT
levels * 5 x ULN (for subjects with documented metastatic disease to the liver).
7. Estimated creatinine clearance * 30 mL/min according to the Cockcroft-Gault
formula (or local institutional standard method)
8. Highly effective contraception for both male and female subjects throughout
the study and for at least 60 days after avelumab treatment administration if
the risk of conception exists. (Note: The effects of the trial drug on the
developing human foetus are unknown; thus, women of childbearing potential and
men able to father a child must agree to use 2 highly effective contraception,
defined as methods with a failure rate of less than 1 % per year. Highly
effective contraception is required at least 28 days prior, throughout and for
at least 60 days after avelumab treatment.)
9. Fit for surgery (for patients with resectable stage Ia-IIIa disease), as
assessed by treating thoracic surgeon / anesthesiologists based on sufficient
cardiopulmonary status and absence of major contra-indications for surgery
according to local guidelines

Exclusion Criteria

1. All subjects with brain metastases, except those meeting the following
criteria:
* Brain metastases that have been treated locally and are clinically stable for
at least 2 weeks prior to enrollment
* No ongoing neurological symptoms that are related to the brain localization
of the disease (sequelae that are a consequence of the treatment of the brain
metastases are acceptable)
* Subjects must be either off steroids or on a stable or decreasing dose of <
10mg daily prednisone (or equivalent)
2. Prior organ transplantation, including allogeneic stem cell transplantation
3. Significant acute or chronic infections including, among others:
* Active infection requiring systemic therapy
* Known history of testing positive test for human immunodeficiency virus (HIV)
or known acquired immunodeficiency syndrome (AIDS)
* Positive test for HBV surface antigen and / or confirmatory HCV RNA (if
anti-HCV antibody tested positive)
4. Active autoimmune disease that might deteriorate when receiving an
immunostimulatory agent:
-. Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid
disease not requiring immunosuppressive treatment are eligible
5. Hypersensitivity to study drug: *Known prior severe hypersensitivity
reactions to investigational product or any component in its formulations,
including known severe hypersensitivity reactions to antibodies (Grade * 3 NCI
CTCAE v 4.03)
6. Persisting toxicity related to prior therapy of Grade >1 NCI-CTCAE v 4.03;
however, alopecia and sensory neuropathy Grade * 2 is acceptable
7. Pregnancy or lactation
8. Known alcohol or drug abuse
9. Other severe acute or chronic medical conditions including colitis,
inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric
conditions including recent (within the past year) or active suicidal ideation
or behavior; or laboratory abnormalities that may increase the risk associated
with study participation or study treatment administration or may interfere
with the interpretation of study results and, in the judgment of the
investigator, would make the patient inappropriate for entry into this study.
10. Any psychiatric condition that would prohibit the understanding or
rendering of informed consent
11. Vaccination within 4 weeks of the first dose of avelumab and while on trial
is prohibited except for administration of inactivated vaccines
12. Immunosuppressants: *Current use of immunosuppressive medication, EXCEPT
for the following: a. intranasal, inhaled, topical steroids, or local steroid
injection (eg, intra-articular injection); b. Systemic corticosteroids at
physiologic doses * 10 mg/day of prednisone or equivalent; c. Steroids as
premedication for hypersensitivity reactions (eg, CT scan premedication).*
13. Cardiovascular disease: *Clinically significant (i.e., active)
cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to
enrollment), myocardial infarction (< 6 months prior to enrollment), unstable
angina, congestive heart failure (* New York Heart Association Classification
Class II), or serious cardiac arrhythmia requiring medication.*
14. Prior anti-PD-1 or anti-PD-L1 therapy