Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With Tyrosine Kinase Inhibitor- (TKI)-Resistant Epidermal Growth Factor Receptor- (EGFR)-Mutated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-789/KEYNOTE-789)
Public ClinicalTrials.gov record NCT03515837. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Phase 3 Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in TKI-resistant EGFR-mutated Tumors in Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Participants (KEYNOTE-789)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib \[TAGRISSO®\] failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy in terms of: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This study will be considered to have met its success criteria if the combination of pembrolizumab plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS. Upon study completion, participants are discontinued and may be enrolled in a pembrolizumab extension study, if available.
Study identification
- NCT ID
- NCT03515837
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 492 participants
Conditions and interventions
Conditions
Interventions
- pembrolizumab Biological
- pemetrexed Drug
- carboplatin Drug
- cisplatin Drug
- saline solution Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 28, 2018
- Primary completion
- Jan 16, 2023
- Completion
- Oct 1, 2023
- Last update posted
- Nov 21, 2024
2018 – 2023
United States locations
- U.S. sites
- 19
- U.S. states
- 11
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Medical Center ( Site 0070) | Los Angeles | California | 90048 | — |
| Pacific Cancer Care ( Site 0058) | Monterey | California | 93940 | — |
| UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0092) | Orange | California | 92868 | — |
| St. Joseph Heritage Healthcare ( Site 0003) | Santa Rosa | California | 95403 | — |
| North Shore University Health System ( Site 0030) | Evanston | Illinois | 60201 | — |
| Siouxland Regioinal Cancer Center dba June E. Nylen Cancer Center ( Site 0065) | Sioux City | Iowa | 51101 | — |
| Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 0048) | Edina | Minnesota | 55435 | — |
| Saint Lukes Hospital of Kansas City ( Site 0060) | Kansas City | Missouri | 64111 | — |
| New York Oncology Hematology P.C ( Site 8000) | Albany | New York | 12208 | — |
| Monter Cancer Center ( Site 0054) | Lake Success | New York | 11042 | — |
| Memorial Sloan Kettering Cancer Center-Rockerfeller Patient Pavilion ( Site 0049) | New York | New York | 10022 | — |
| White Plains Hospital Center for Cancer Care ( Site 0014) | White Plains | New York | 10601 | — |
| Providence Portland Medical Center ( Site 0097) | Portland | Oregon | 97213 | — |
| Kaiser Permanente Northwest ( Site 0037) | Portland | Oregon | 97227 | — |
| Parkland Health & Hospital System ( Site 2102) | Dallas | Texas | 75235 | — |
| University of Texas Southwestern Medical Center at Dallas ( Site 0035) | Dallas | Texas | 75390 | — |
| Utah Cancer Specialists ( Site 0001) | Salt Lake City | Utah | 84106 | — |
| Emily Couric Clinical Cancer Center ( Site 0020) | Charlottesville | Virginia | 22903 | — |
| Froedtert Hospital & the Medical College of Wisconsin ( Site 0041) | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 139 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03515837, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 21, 2024 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03515837 live on ClinicalTrials.gov.