Overview
Study of Avelumab and Cetuximab Plus Gemcitabine and Cisplatin in Participants With NSCLC
Status:
Completed
Completed
Trial end date:
2021-05-27
2021-05-27
Target enrollment:
0
0
Participant gender:
All
All
Summary
The main purpose of the study was to investigate the clinical activity and safety of avelumab in combination with cetuximab plus gemcitabine and cisplatin in participants with treatment-naïve advanced squamous (NSCLC).Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Merck KGaA
Merck KGaA, Darmstadt, GermanyTreatments:
Antibodies, Monoclonal
Avelumab
Carboplatin
Cetuximab
Cisplatin
Gemcitabine
Criteria
Inclusion Criteria:- Histologically-confirmed Stage IV metastatic or recurrent (Stage IV) NSCLC of squamous
histology
- Availability of formalin-fixed paraffin-embedded (FFPE) block containing tumor tissue
or a minimum of 15 (preferably 25) unstained tumor slides (cut within 1 week) suitable
for Programmed death ligand 1 (PD-L1) expression and epidermal growth factor receptor
(EGFR) expression/amplification assessments
- At least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST)
v1.1 criteria
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at study
entry
- Adequate hematological, hepatic and renal function
- Estimated life expectancy of at least 3 months
- Can give signed informed consent
- Other protocol defined inclusion criteria could apply
Exclusion Criteria:
- Participants whose tumor disease harbors an activating EGFR mutation or ALK
rearrangement. Participants with tumors of unknown EGFR or ALK status will require
testing only in never smokers
- All participants with brain metastases with protocol defined exceptions
- Previous malignant disease (other than NSCLC) within the last 5 years (except
adequately treated non-melanoma skin cancers, carcinoma in situ of skin, bladder,
cervix, colon/rectum, breast, or prostate) unless a complete remission without further
recurrence was achieved at least 2 years prior to study entry and the participant was
deemed to have been cured with no additional therapy required or anticipated to be
required
- Active infection requiring systemic therapy
- Known history of human immunodeficiency virus or known acquired immunodeficiency
syndrome
- Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive
HBV surface antigen or HCV ribonucleic acid (RNA) if anti-HCV antibody screening test
positive)
- Active autoimmune disease that might deteriorate when receiving an immunostimulatory
agent
- Interstitial parenchymal lung disease
- Pregnancy or lactation
- Known alcohol or drug abuse as determined by the Investigator
- History of uncontrolled intercurrent illness
- Clinically significant (that is active) cardiovascular disease
- Known history of inflammatory colitis, inflammatory bowel disease, pneumonitis,
pulmonary fibrosis
- Any psychiatric condition that would prohibit the understanding or rendering of
informed consent or that would limit compliance with study requirements
- Prior/Concomitant Therapy as described in protocol
- Use of any investigational drug within 28 days before the start of study treatment
- Other protocol defined exclusion criteria could apply