CRC 14014: A Phase 3, Multicenter, Randomized, Open?Label Cross-Over Safety and Efficacy Study to Evaluate Nab-Paclitaxel (Abraxane) as Maintenance Treatment After Induction With Nab-Paclitaxel Plus Carboplatin in Subjects With Squamous Cell NSCLC
Purpose: The purpose of this research study is to find out if a drug called nab-paclitaxel (Abraxane®) and best supportive care, when given after response with nab-paclitaxel and carboplatin, is safe and can help to control the disease and also increase the length of time people respond compared to the standard of care best supportive care alone for subjects with advanced stage squamous cell Non-small Cell Lung Cancer (NSCLC).
Cancer () - Lung
Howard (Jack) West, M.D.
Swedish Cancer Institute
- Understand and voluntarily provide written consent.
- Age ≥ 18 years of age at the time of signing the Informed Consent Form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Histologically or cytologically confirmed Stage IIIB or IV squamous cell Non Small Cell Lung Cancer at study entry.
- No prior history of other malignancies, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- Radiographically documented measurable disease at study entry.
- No prior chemotherapy for the treatment of metastatic disease at study entry. Adjuvant chemotherapy is permitted providing cytotoxic chemotherapy was completed 12 months prior to starting the study and without disease recurrence.
- Absolute neutrophil count ≥ 1500 cells/mm3.
- Platelets ≥ 100,000 cells/mm3.
- Hemoglobin ≥ 9 g/dL.
- Aspartate transaminase/serum glutamic oxaloacetic transaminase, alanine transaminase/serum glutamic pyruvic transaminase ≤ 2.5 × upper limit of normal range or ≤ 5.0 × upper limit of normal range if liver metastases.
- Total bilirubin ≤ 1.5 × upper limit of normal range except in cases of Gilbert's disease and liver metastases.
- Creatinine ≤ 1.5 mg/dL.
- Expected survival of > 12 weeks for the Induction part of the study.
- Eastern Cooperative Oncology Group performance status 0 or 1.
- For Maintenance part of the study, subjects must have received at least one dose of nab-paclitaxel in each of the 4 cycles during Induction Pregnancy
- Females of childbearing potential must
- Abstain from breastfeeding during study participation and 3 months after IP discontinuation.
- Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 3 months after discontinuation of study therapy.
- Have a negative pregnancy test as verified by the study doctor prior to starting study therapy.
- Male subjects must:
- Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 3 months following study drug discontinuation, even if he has undergone a successful vasectomy.