Concurrent Nab-P/Carboplatin and Thoracic Radiotherapy in Squamous Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2022-11-06
• Target enrollment: 0
• Participant gender: All

Summary

Nab-paclitaxel and carboplatin showed better treatment response compared with cremophor-based paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer, especially for squamous cell cancer. This study is conducted to evaluate the efficacy and safety of nab-paclitaxel, carboplatin and concurrent radiotherapy in patients with local advanced inoperable squamous cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan University
• Collaborator: CSPC Ouyi Pharmaceutical Co., Ltd.
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Age: 18 Years to 70 Years

• Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.

• Previously untreated, histological documented, inoperable stage III squamous cell carcinoma of lung, excluding those with pericardial, pleural effusion, and those with contralateral hilar or contralateral supraclavicular lymph nodes.

• Patients must have measurable disease according to RECIST criteria, and all detectable tumor can be encompassed by radiation therapy fields.

• Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.

• Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.

• Patients must sign a study-specific informed consent form prior to study entry.

Exclusion Criteria:

• Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.

• Previous chemotherapy or previous biologic response modifiers for current lung cancer.

• Patient has previously had thoracic radiation therapy.

• Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for five years or more.

• Serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.

• History of significant neurological or mental disorder, including seizures or dementia.