A phase III clinical study to evaluate the efficacy and safety of MPDL3280A in combination with carboplatin + nab-paclitaxel in stage IV non-squamous non-small cell lung cancer patients.
- Conditions
- STAGE IV NON-SQUAMOUS NON-SMALL CELL LUNG CANCERTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-003206-32-FR
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 723
• ECOG performance status of 0 or 1
• Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
• No prior treatment for Stage IV non-squamous NSCLC
Patients with a sensitizing mutation in the EGFR gene must have experienced disease progression (during or after treatment) or intolerance to treatment with erlotinib, gefitinib, or another EGFR tyrosine kinase inhibitor (TKI) appropriate for the treatment of EGFR-mutant NSCLC. Patients not previously tested for mutational status and who have not been previously treated with an EGFR TKI will be required to be tested at screening.
Patients with an ALK fusion oncogene must have experienced disease progression (during or after treatment) or intolerance to treatment with one or more ALK inhibitors (i.e., crizotinib) appropriate for the treatment of NSCLC in patients having an ALK fusion oncogene. Patients not previously tested for ALK status and who have not previously been treated with an ALK inhibitor will be requred to be tested at screening.
• Patients who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last chemotherapy or chemoradiotherapy cycle.
•Measurable disease, as defined by RECIST v1.1
•Known PD-L1 tumor status as determined by an IHC assay performed by a centrallaboratory on previously obtained archival tumor tissue or tissue obtained from abiopsy at screening
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 330
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 220
•Active or untreated CNS metastases as determined by CT or MRI evaluation duringscreening and prior radiographic assessments
•Spinal cord compression not definitively treated with surgery and/or radiation orpreviously diagnosed and treated spinal cord compression without evidence thatdisease has been clinically stable for > 2 weeks prior to randomization
•Leptomeningeal disease
•Uncontrolled tumor-related pain
Patients requiring pain medication must be on a stable regimen at study entry.
Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should be treated prior to randomization. Patients should be recovered from the effects of radiation. There is no required minimum recovery period.
Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for locoregional therapy, if appropriate, prior to randomization.
•Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrentdrainage procedures (once monthly or more frequently)
•Malignancies other than NSCLC within 5 years prior to randomization, with theexception of those with a negligible risk of metastasis or death (e.g., expected5-year OS> 90%) treated with expected curative outcome (such as adequatelytreated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localizedprostate cancer treated surgically with curative intent, ductal carcinoma in situtreated surgically with curative intent)
•Known tumor PD-L1 expression status from other clinical trials (e.g., patients whosePD-L1 expression status was determined during screening for entry into a trial withanti-programmed death-1 [PD-1] or anti-PD-L1 antibodies but were not eligible areexcluded)
•History of severe allergic, anaphylactic, or other hypersensitivity reactionsto chimeric or humanized antibodies or fusion proteins
•Positive test for HIV
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method