Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Cisplatin

Necitumumab

Antimetabolites

Antineoplastic Agents, Immunological

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.

* 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.

Necitumumab-Gemcitabine-Cisplatin

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

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

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.

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.

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

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.

Eli Lilly and Company

Montefiore Medical Center

Director of Thoracic Oncology / Assistant Professor of Medicine

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.

Necitumumab-Gemcitabine-Cisplatin: / 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.

Spots Global Cancer Trial Database for evaluation to determine if patient is a candidate to proceeed with surgical resection or not