Clinical Trials Logo

Clinical Trial Summary

This study is to assess the pharmacokinetics (PK) and safety of SC MK-3475A vs intravenous (IV) pembrolizumab, administered with chemotherapy in first line treatment of adult Japanese participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are MK-3475A subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.


Clinical Trial Description

Japan extension study will require approximately six years which includes one additional year (beyond the global study's last participant last study related contact) from the time the first participant (or their legally acceptable representative) provides informed consent until the last participant's last study related contact to complete. The Japan extension study will include participants previously enrolled in Japan in the global study for MK-3475A-D77 (NCT05722015) plus the study will continue to enroll participants in Japan until the sample size for participants in Japan reaches approximately 39. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06212752
Study type Interventional
Source Merck Sharp & Dohme LLC
Contact
Status Active, not recruiting
Phase Phase 3
Start date June 13, 2023
Completion date May 22, 2028

See also
  Status Clinical Trial Phase
Completed NCT02857270 - A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer Phase 1
Not yet recruiting NCT05985330 - Pilot Study of the Contribution of Fractional Exhaled Nitric Oxide as a Prognostic Marker of Response to Anti-PD-L1 Immunotherapy in Non-small Cell Lung Cancer
Recruiting NCT05013450 - Dupilumab_Metastatic NSCLC Phase 1/Phase 2
Recruiting NCT05984277 - A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer. Phase 3
Completed NCT03215810 - Nivolumab and Tumor Infiltrating Lymphocytes (TIL) in Advanced Non-Small Cell Lung Cancer Phase 1
Completed NCT05675683 - Real-World Assessment of Clinical Outcomes in Metastatic NSCLC Patients With MET Exon 14 Skipping Mutation and Brain Metastases Treated With Capmatinib
Active, not recruiting NCT02411448 - A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY) Phase 3
Recruiting NCT04410796 - Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers Phase 2
Recruiting NCT06343402 - Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer Phase 1
Recruiting NCT03300115 - Clinical Trial of the Efficacy and Safety of AC0010 in the Treatment of EGFR T790M Patients With Advanded NSCLC Phase 2
Recruiting NCT05635708 - A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer Phase 2
Terminated NCT03265080 - A Study of ADXS-NEO Expressing Personalized Tumor Antigens Phase 1
Active, not recruiting NCT05226598 - Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007) Phase 3
Withdrawn NCT02639234 - Vigilâ„¢ + Nivolumab in Advanced Non-Small Cell Lung Cancer Phase 2
Recruiting NCT05364073 - Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations Phase 1
Completed NCT03926260 - Early Assessment of Response to Treatment of Metastatic LUng Tumors Based on CIrculating Tumor DNA N/A
Active, not recruiting NCT03976375 - Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008) Phase 3
Recruiting NCT05546905 - A Study in Patients With BRAF V600E-mutant Metastatic Non-small Cell Lung Cancer (OCTOPUS)
Withdrawn NCT01936961 - Study of Immunochemotherapy +/- Hypofractionated Radiation for Complete Response in Solid Tumors N/A
Not yet recruiting NCT06428422 - The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients N/A