The following pembrolizumab substudies will evaluate the efficacy of different
investigational agents in combination with pembrolizumab given in sequence or in
combination with pembrolizumab PLUS chemotherapy:
- KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of
Investigational Agents, With Pembrolizumab With or Without Chemotherapy in
Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)
(MK-3475-01A) - NCT04165070
- KEYMAKER-U01 Substudy 2: A Phase 2, Umbrella Study with Rolling Arms of
Investigational Agents in Combination with Pembrolizumab in Treatment Naïve Patients
with PD-L1 Positive Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-01B) -
NCT04165083
- KEYMAKER-U01 Substudy 3: A Phase 2, Umbrella Study with Rolling Arms of
Investigational Agents in Combination with Pembrolizumab in Patients with Advanced
Non-small Cell Lung Cancer (NSCLC) Previously Treated with anti-PD-(L)1 Therapy
(MK-3475-01C) - NCT04165096
- KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of
Investigational Agents With or Without Chemotherapy in Combination With
Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages
II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E) - NCT06788912
- KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of
Investigational Agents for Second-line Treatment of Participants With Advanced or
Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations
(MK-3475-01F) - NCT number pending
- KEYMAKER-U01 Substudy 01G: A Phase 2, Umbrella Study With Rolling Arms of
Investigational Agents in Combination With Pembrolizumab With or Without
Platinum-based Chemotherapy in Treatment-Naïve Participants With Stage IV Non-small
Cell Lung Cancer (NSCLC) (MK-3475-01G) - NCT06731907
- KEYMAKER-U01 Substudy 01H: A Phase 2, Randomized, Umbrella Study With Rolling Arms
of Investigational Agents in Participants with Previously Treated Stage IV
Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H) - NCT06780085
- KEYMAKER-U01 Substudy 01I: A Phase 2, Randomized, Umbrella Study With Rolling Arms
of Investigational Agents in Participants With Previously Treated Stage IV Squamous
Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I) - NCT06780098
- KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of
Investigational Agents for First-line Treatment of Participants With Advanced or
Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations
(MK-3475-01J) - NCT number pending