A study of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based DoubletChemotherapy in patients with lung cancer
- Conditions
- Therapeutic area: Diseases [C] - Cancer [C04]on-Small Cell Lung Cancer
- Registration Number
- EUCTR2017-001311-36-AT
- Lead Sponsor
- Regeneron Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
1. Men and women =18 years of age.
2. Patients with histologically or cytologically documented squamous or
non-squamous NSCLC with stage IIIB disease who are not candidates
for treatment with definitive concurrent chemoradiation or patients with
stage IV disease if they have not received prior systemic treatment for
recurrent or metastatic NSCLC.
3. Availability of an archival (=5 months) or on-study obtained formalinfixed,
paraffinembedded
tumor
tissue sample from a metastatic/recurrent site, which has not
previously
been
irradiated.
4.
Part 1 only: Expression of PD-L1 in <50% of tumor cells determined
by
the commercially available
assay performed by the central laboratory.
5.
At least 1 radiographically measureable lesion by computed
tomography
(CT) or
magnetic
resonance imaging (MRI) per RECIST 1.1 criteria. Target
lesions
may be located in a previously irradiated field if there is
documented
(radiographic)
disease progression in that site.
6.
ECOG performance status of =1.
7.
Anticipated life expectancy of at least 3 months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 585
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225
1. Part 1 only: Patients who have never smoked, defined as smoking =
100 cigarettes in a lifetime.
2. Active or untreated brain metastases or spinal cord compression.
Patients are eligible if
central nervous system (CNS) metastases are adequately treated and
patients have
neurologically returned to baseline (except for residual signs or
symptoms related to the
CNS treatment) for at least 2 weeks prior to enrollment. Patients must
be off
(immunosuppressive doses of) corticosteroid therapy (see exclusion
criteria 7) for details
on timing of discontinuation of steroids).
3. Patients with tumors tested positive for EGFR gene mutations, ALK
gene translocations,
or ROS1 fusions. All patients will have tumor evaluated for EGFR
mutations, ALK
rearrangement, and ROS1 fusions.
4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to
informed consent.
5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis
or organizing
pneumonia), of active, noninfectious pneumonitis that required immunesuppressive
doses
of glucocorticoids to assist with management, or of pneumonitis
within
the last
5
years. A history of radiation pneumonitis in the radiation field is
permitted
as long as
pneumonitis
resolved =6months prior to enrollment.
6.
Ongoing or recent evidence of significant autoimmune disease that
required
treatment
with
systemic immunosuppressive treatments, which may suggest risk
of
immune-related
treatment-emergent
adverse events (irTEAEs). The following are not
exclusionary:
vitiligo,
childhood asthma that has resolved, residual hypothyroidism
that
required only
hormone
replacement, or psoriasis that does not require systemic
treatment.
7. Patients with a condition requiring corticosteroid therapy (>10 mg
prednisone/day or
equivalent) within 14 days of randomization. Physiologic replacement
doses are allowed
even if they are >10 mg of prednisone/day or equivalent, as long as they
are not being
administered for immunosuppressive intent. Inhaled or topical steroids
are permitted,
provided that they are not for treatment of an autoimmune disorder.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method