Necitumumab in the Neoadjuvant Setting With Gemcitabine in Surgically Resectable - 14X-US-I001

Stopped early · Phase 2

Conditions studied: Squamous Cell Lung Cancer

In brief

This will be a single-arm study to primarily evaluate the feasibility of administering necitumumab added to gemcitabine and cisplatin as neoadjuvant treatment in treatment-naïve patients with stage IB (tumor size \>4cm), II or IIIA squamous NSCLC. Feasibility will be assessed by the proportion of patients able to proceed to surgery after administering necitumumab in the neoadjuvant setting. These patients would otherwise be offered standard adjuvant chemotherapy (without necitumumab) for squamous cell lung cancer. Determination of surgical resectability will be reviewed at a multidisciplinary thoracic tumor board, attended by surgical oncology, medical oncology, radiation oncology, radiology, and pathology.

Key facts

Study ID: NCT03574818
Run by: Montefiore Medical Center
People needed: 1
Starts: 2018-05-29
Expected to finish: 2019-09-26
Last updated by the study team: 2020-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically or cytologically confirmed squamous cell non-small cell lung cancer with any of the following stage groupings: IB with tumor size >4cm, II or potentially resectable IIIA.
Patients who have been evaluated by thoracic surgery and eligible for resection.
Patients must have adequate fresh frozen paraffin embedded (FFPE) tumor tissue available to perform pre-treatment biomarker testing.
No prior systemic treatment for squamous cell non-small cell lung cancer.
Age ≥18 years.
ECOG performance status 0-1 (Karnofsky ≥70%, see Appendix A).
Patients must have hematologic function as defined by:
absolute neutrophil count ≥1.5 x 109/L
hemoglobin ≥9.0 g/dL
platelets ≥100 x 109/L
Patients must have organ function as defined below:
bilirubin ≤1.5 × the upper limit of normal (ULN), alkaline phosphatase (ALP), alanine aminotransferase (ALT) and asparate transaminase (AST) ≤3.0 times ULN. For patients with hepatic metastases, ALT and AST equaling ≤5.0 times ULN are acceptable.
If a patient experiences elevated ALT >5 × ULN and elevated total bilirubin >2 × ULN, clinical and laboratory monitoring should be initiated by the investigator. For patients entering the study with ALT >3 × ULN, monitoring should be triggered at ALT >2 × baseline.
calculated creatinine clearance >50mL/min (per the Cockcroft-Gault formula).
serum albumin ≥2.5 g/dL
Patients may be on a stable regimen of therapeutic anticoagulation or may be receiving prophylactic anticoagulation of venous access devices.
The patient is a woman of child-bearing potential who tests negative for pregnancy within 14 days prior to receiving first dose of study medication based on serum pregnancy test and agrees to use 2 methods of birth control or abstain from heterosexual activity during the study and for 6 months following the last dose of the study drug(s) or country requirements, whichever is longer or be of non-child bearing potential.
Non-childbearing potential is defined as (by other than medical reasons):
≥45 years of age and has not had menses for greater than 2 years,
amenorrheic for < 2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pretrial (screening) evaluation, or
post hysterectomy, oophorectomy or tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 6 months after the last dose of study therapy.
Ability to understand and the willingness to sign a written informed consent document.
The patient is willing to comply with protocol schedules and testing. -
Exclusion Criteria: Patients with histologically or cytologically confirmed non-squamous cell, small cell or mixed histology lung carcinoma.
Patients with stage IIIB or stage IV disease.

Where it is running

Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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