Neoadjuvant Chemo for Non-metastatic Non-small Cell Lung Cancer

Phase 2

Terminated

• Conditions: Squamous Cell Non-Metastatic Non-Small Cell Lung Cancer; Non-squamous Cell Non-Metastatic Non-Small Cell Lung Cancer
• Interventions: Drug: Cisplatin; Drug: Gemcitabine; Drug: Pemetrexed

• Registration Number: NCT01860040
• Lead Sponsor: Western Regional Medical Center

Brief Summary

To determine the rate of pathologic complete responses (pCR) at the time of definitive surgical resection of non-small cell lung cancer (NSCLC)

Detailed Description

Participants in this study will have a lung mass and are undergoing a procedure to determine if they have non-small cell lung cancer that could be removed surgically. If confirmed to have non-small cell lung cancer that can be surgically removed, he or she may be able to continue as a possible participant in this study.

The purpose of this study is to determine whether neoadjuvant chemotherapy (chemotherapy that is given before surgery) will improve the amount of time a participant is free from disease in people with non-metastatic (has not spread from the original site) non-small cell lung cancer. The chemotherapy medications that will be used in this study are cisplatin and pemetrexed or cisplatin and gemcitabine and have been shown to be effective in patients with non-small cell lung cancer.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-17
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-22
• Primary Completion: 2014-09
• Study Completion: 2016-04
• Results First Submitted: 2016-04-26
• Results First Submitted QC: 2017-09-23
• Results First Posted: 2017-10-25
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-11
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

1. Patients ≥ 18 years of age with either a mass suspicious for or histologically confirmed AJCC stage IB-IIIA NSCLC. For those without histologic confirmation of NSCLC, a biopsy will be done and only those patients with histologically confirmed NSCLC meeting all other eligibility criteria may proceed on protocol.
2. Mass must be determined to be surgically resectable
3. Eastern Cooperative Oncology Group (ECOG) performance status score < 1 and a life expectancy >3 months.
4. Participants must have at least one evaluable lesion as defined by RECIST 1.1
5. Absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5 g/dL
6. Serum creatinine ≤1.3 mg/dL (candidate for cisplatin chemotherapy), total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 5 times the upper limit of normal range
7. No prior chemotherapy or radiotherapy for NSCLC
8. At least 5 years from diagnosis of another cancer except treated in-situ disease or surgically resected non-melanoma skin cancer with clear margins.
9. Willingness to provide permission to biopsy NSCLC for collection of frozen pretreatment sample.
10. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial

Exclusion Criteria

1. Active clinically serious infection > CTCAE (version 4.03) Grade 2.
2. Serious non-healing wound, ulcer, or bone fracture.
3. Major contraindication to surgical resection of NSCLC
4. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
5. Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.
6. Patients receiving any other investigational agents.
7. Pregnant or lactating females

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cisplatin and pemetrexed	Cisplatin	Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles
Cisplatin and gemcitabine	Gemcitabine	Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles
Cisplatin and pemetrexed	Pemetrexed	Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles
Cisplatin and gemcitabine	Cisplatin	Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles

Primary Outcome Measures

Name	Time	Method
Rate of Pathologic Complete Responses (pCR) at the Time of Definitive Surgical Resection of Non-small Cell Lung Cancer	One year	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic Resonance Imagery (MRI): Complete Response (CR), Disappearance of all target lesions

Trial Locations

Locations (1)

Western Regional Medical Center; 🇺🇸 Goodyear, Arizona, United States