At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed stage IV non-squamous NSCLC
- ✓EGFR or ALK-directed therapy is not indicated
- ✓Measurable disease present
- ✓No prior systemic treatment for advanced/metastatic NSCLC
- ✕Predominantly squamous cell histology
- ✕Prior systemic cytotoxic chemotherapy, antineoplastic biological therapy, or major surgery within 3 weeks
- ✕Radiation to lung >30 Gy within 6 months or palliative radiotherapy within 7 days
- ✕Known active CNS metastases or carcinomatous meningitis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Phase III Study of Platinum+Pemetrexed Chemotherapy With or Without Pembrolizumab (MK-3475) in First Line Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-189)
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab 200 mg, Cisplatin, and 6 other interventions for Non-Small-Cell Lung Carcinoma. Completed, enrolled 616 participants.
Detailed Summary
This is an efficacy and safety study of pembrolizumab (MK-3475) combined with pemetrexed/platinum chemotherapy versus pemetrexed/platinum chemotherapy alone in participants with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease. Participants will be randomly assigned to receive pembrolizumab combined with pemetrexed/platinum (Investigators choice of cisplatin or carboplatin), OR pemetrexed/platinum (Investigators choice of cisplatin or carboplatin). With Amendment 10 (effective date 23-Dec-2019), active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded, and all participants in the 'control' arm will discontinue saline placebo. With Amendment 11 (effective date 31-Jan-2022), once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment. The primary hypothesis is that pembrolizumab in combination with pemetrexed/platinum chemotherapy prolongs Progression-Free Survival (PFS) and Overall Survival (OS) compared to pemetrexed/platinum chemotherapy alone.
Study Details
Timeline
Interventions
IV infusion
IV infusion
IV infusion
IV infusion
Orally; at least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and folic acid dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed.
Intramuscular injection in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration.
For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.
IV infusion