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Necitumumab in the Neoadjuvant Setting With Gemcitabine in Surgically Resectable - 14X-US-I001 | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

A Feasibility and Biomarker Study to Evaluate Necitumumab in the Neoadjuvant Setting With Gemcitabine and Cisplatin in Surgically Resectable Squamous Lung Cancer

NCT03574818•Montefiore Medical Center

View on ClinicalTrials.gov

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.

Detailed Description

The goal of this study is to explore whether it is possible to add a drug called necitumumab to standard treatment for patients with squamous cell lung cancer that can be surgically removed. This study is important because it will determine whether there is added benefit to giving necitumumab with chemotherapy before surgery. It is currently already known that chemotherapy given before or after surgery has better outcomes compared to only receiving surgery. Results from this study may help to develop more effective treatments for patients with squamous cell lung cancer. The U.S. Food and Drug Administration (FDA) has approved necitumumab in combination with chemotherapy drugs called gemcitabine and cisplatin to treat stage IV or metastatic squamous cell lung cancer, but the FDA has not approved necitumumab to treat squamous cell lung cancer that can be surgically removed. Analyzing the tumor cells from many cases of squamous cell lung cancer has shown that this cancer often has a special protein called EGFR. Necitumumab is a drug that targets EGFR. Results from a recent medical study showed that patients with stage IV or metastatic squamous cell lung cancer who received necitumumab with gemcitabine and cisplatin showed a small, but significant, improvement in survival. We believe trying to gather more information about the way necitumumab interacts with cancer cells will help to learn how to use necitumumab more effectively. This study will allow to see the effects of treating an earlier stage of squamous cell lung cancer using necitumumab with gemcitabine and cisplatin. It will also allow us to better analyze tumor cells after they have been treated with necitumumab and chemotherapy that are obtained after surgical resection. Other blood samples that will be drawn during the treatment will also allow to see the effect of necitumumab on both the body and the tumor cells and to observe any side effects that may result from this treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+13 more criteria

Exclusion Criteria

•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.
+2 more criteria

Locations (1)

Montefiore Medical Center

The Bronx, New York, United States

Key Dates

Start Date

May 29, 2018

Primary Completion Date

October 25, 2018

Completion Date

September 26, 2019

Last Updated

March 18, 2020

Enrollment

ACTUAL participants

Conditions

Squamous Cell Lung Cancer

Interventions

Necitumumab-Gemcitabine-Cisplatin

DRUG

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

DIAGNOSTIC_TEST

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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