Study of BMS-936558 compared to Docetaxel in previously treated advanced or metastatic Squamous cell NSCLC
- Conditions
- Squamous cell Non-small cell lung cancerMedDRA version: 17.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-004792-36-DE
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 320
1) men & women = 18 years of age
2) Subjects with histologically or cytologically-documented squamous cell NSCLC who present with Stage IIIB/IV disease or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease.)
3) Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease
4) Measurable disease by CT/MRI per RECIST 1.1 criteria
5) ECOG performance status = 1
6) An FFPE tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient.
Specific eligibility criteria for subjects originally randomized to the docetaxel arm B and now entering the Nivolumab Extension Phase are included in the protocol in Section 3.3.1.1 and Section 3.3.2.1.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 198
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 122
1) Subjects with untreated CNS metastases are excluded. Subjects are eligible if CNS metastases are treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of = 10mg daily prednisone (or equivalent)
2) Subjects with carcinomatous meningitis.
3) Subjects with active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
4) Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization.
5) Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
6) Prior treatment on the first line study CA184104 first line NSCLC study
7) Prior treatment with docetaxel
8) Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.
9) Treatment with any investigational agent within 14 days of first administration of study treatment.
Specific eligibility criteria for subjects originally randomized to the docetaxel arm B and now entering the Nivolumab Extension Phase are included in the protocol in Section 3.3.1.1 and Section 3.3.2.1.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of the study is to compare the change in tumor size, and overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy;Secondary Objective: 1. To compare the ORR of BMS-936558 (nivolumab) versus docetaxel<br>2. To compare the progression-free survival (PFS) of BMS-936558 (nivolumab) versus docetaxel<br>3. To evaluate whether PD-L1 is a predictive biomarker for OS, ORR, or PFS.<br>4. To evaluate the proportion of subjects exhibiting disease-related symptom improvement by 12 weeks as measured by LCSS, in BMS-936558 (nivolumab) and docetaxel groups;Primary end point(s): To compare the OS of BMS-936558 (nivolumab) versus docetaxel in subjects with squamous cell NSCLC after failure of prior-platinum doublet-based chemotherapy.;Timepoint(s) of evaluation of this end point: 38 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. To compare the ORR of BMS-936558 (nivolumab) versus docetaxel<br>2. To compare the progression-free survival (PFS) of BMS-936558 (nivolumab) versus docetaxel<br>3. To evaluate whether PD-L1 is a predictive biomarker for OS, ORR, or PFS.<br>4. To evaluate the proportion of subjects exhibiting disease-related symptom improvement by 12 weeks as measured by LCSS, in BMS-936558 (nivolumab) and docetaxel groups;Timepoint(s) of evaluation of this end point: 38 months