A Phase IIa, single-arm, multi center study to investigate the clinical activity and safety ofavelumab in combination with cetuximab plus gemcitabine and cisplatin in participants with advanced squamous non-small-cell lung cancer

Merck KGaA0 sites40 target enrollmentJuly 26, 2018

Conditionson Small Cell Lung Cancer MedDRA version: 21.1Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsAvelumab Erbitux

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: on Small Cell Lung Cancer
Sponsor: Merck KGaA
Enrollment: 40
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 26, 2018

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck KGaA

Eligibility Criteria

Inclusion Criteria

•Participants are eligible to be included in the study only if all the following criteria apply:
•1\. Are 18 years or older, at the time of signing the informed consent
•Type of Participant and Disease Characteristics
•2\. Histologically\-confirmed Stage IV metastatic or recurrent (Stage IV) NSCLC of squamous histology as per the 7th International Association for the Study of Lung Cancer and the American Joint Committee on Cancer classifications.
•3\. 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 PD\-L1 expression and EGFR expression/amplification assessments, from a recently obtained (within 6 months) biopsy or a fresh baseline tumor biopsy collected from a non\-irradiated area.
•4\. At least 1 measurable lesion per RECIST v1\.1 criteria. A lesion that has been irradiated can be used as a measurable lesion providing that disease has progressed at that site
•5\. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at study entry.
•6\. Adequate hematological function defined by white blood cell (WBC) count \= 2\.5 × 109/L with absolute neutrophil count (ANC) \= 1\.5 × 109/L, lymphocyte count \= 0\.5 × 109/L, platelet count \= 100 × 109/L, and hemoglobin \= 9 g/dL (may have been transfused).
•7\. Adequate hepatic function defined by a total bilirubin level \= 1\.5 × the upper limit of normal (ULN) range and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels \= 2\.5 × ULN except for participants with documented metastatic disease to the liver for whom AST and ALT levels \= 5 × ULN are acceptable. Patients with documented Gilbert disease are allowed if total bilirubin is less than 3 × ULN.
•8\. Adequate renal function defined by an estimated creatinine clearance \> 60 mL/minute according to the Cockcroft\-Gault formula. or by 24\-hour urine collection for creatinine clearance or according to local institutional standard method.

Exclusion Criteria

•1\. 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.
•2\. All participants with brain metastases, except those meeting the following criteria:
•a. Brain metastases that have been treated locally and are clinically stable for at least 4 weeks prior to treatment start.
•b. 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).
•c. Participants must be either off steroids or on a stable or decreasing dose of \< 10mg daily prednisone (or equivalent).
•3\. 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.