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

NCT03574818 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 2017-8108
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Squamous Cell Lung Cancer

Keywords

Neoadjuvant Chemotherapy; NSCLC; nacitumumab

Outcome Measures

Primary Outcomes (1)

• Surgically Resectable

  Patients able to proceed to surgery after administering necitumumab in the neoadjuvant setting with gemcitabine and cisplatin in surgically resectable patients with stage IB with tumor size \>4cm, II and potentially resectable IIIA squamous cell lung cancer.

  up to 63 days

Study Arms (1)

Arm 1

EXPERIMENTAL

Chemotherapy and Necitumumab Regimen Gemcitabine 1250mg/m2 IV over 30 minutes, days 1 and 8 following necitumumab, Cisplatin 75mg/m2 IV over 60 minutes, day 1, immediately following gemcitabine,each cycle is 3 weeks (21 days). Necitumumab 800mg absolute dose IV over a minimum of 60 minutes, days 1 and 8 prior to chemotherapy regimen Each cycle is 3 weeks (21 days). The regimen will be given for a total of 3 cycles. The regimen will be given for a total of 3 cycles.

Drug: Necitumumab-Gemcitabine-Cisplatin; Diagnostic Test: Evaluation to determine if patient is a candidate to proceeed with surgical resection or not

Interventions

Necitumumab-Gemcitabine-Cisplatin DRUG

* Gemcitabine 1250mg/m2 IV on D1, D8 * Cisplatin 75mg / m2 IV on D1 * Necitumumab 800mg IV on D1, D8 (peripheral blood for effector cells and cytokine measurements prior to each cycle) Repeat cycle every 21 days up to 3 cycles.

Also known as: PORTRAZZA™ - GEMZAR™ - PLATINOL™

Arm 1

Evaluation to determine if patient is a candidate to proceeed with surgical resection or not DIAGNOSTIC_TEST

Patients will be evaluated with repeat imaging studies (PET/CT or CT Chest, Abdomen, Pelvis) and will be re-evaluated for surgical resection. Patients who had progressive disease or are NOT a surgical candidate will come off the study and will be treated according to standard therapies. All patients will be followed up for 2-year disease-free survival and overall survival

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

You may not qualify if:

• Patients with stage IIIB or stage IV disease.
• Prior history of other malignancy, provided that he/she has been free of disease for ≥3 years, with the exception of in-situ carcinoma of the cervix or completely resected basal cell carcinoma of the skin.
• Patients who are receiving any other investigational agents.
• The patient has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab, or any other contraindication to one of the administered treatments.
• History or evidence of current clinically relevant coronary artery disease ≥ Grade III by the Canadian Cardiovascular Society Angina Grading Scale or uncontrolled congestive heart failure of current \> Class III as defined by the New York Heart Association.
• The patient has experienced myocardial infarction within 6 months prior to study enrollment.
• The patient has any ongoing or active infection, including active tuberculosis or known infection with the human immunodeficiency virus.
• Recent (within 30 days before enrollment) or concurrent yellow fever vaccination.
• The patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment.
• History of arterial or venous thromboembolism within 3 months prior to study enrollment. Patients with a history of venous thromboembolism beyond 3 months prior to study enrollment can be enrolled if they are appropriately treated with low molecular weight heparin.
• The patient has any NCI-CTCAE Version 4.0 Grade ≥2 peripheral neuropathy.
• The patient has any other serious uncontrolled medical disorders or psychological conditions that would, in the opinion of the investigator, limit the patient's ability to complete the study or sign an informed consent document.

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Balazs Halmos
• Organization: Montefiore Medical Center

bahalmos@montefiore.org

7184058404

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Thoracic Oncology / Assistant Professor of Medicine

Model Details: Feasibility and Biomaker Study

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: July 2, 2018
• Study Start: May 29, 2018
• Primary Completion: October 25, 2018
• Study Completion: September 26, 2019
• Last Updated: March 18, 2020
• Results First Posted: February 18, 2020

Record last verified: 2020-03

Locations

US (1)