18 and older, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response RatePrimary· Up to ~25 months
Objective response rate is the proportion of participants who have a confirmed complete response (CR) or partial response (PR). Objective response rate is assessed by investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants with missing data are c
Cell-free ctDNA allows the exploration of tumor features from blood samples. TMB is a measure of mutational load in tumor cells and expressed as the number of somatic mutations per megabase (mut/MB) of DNA. The mean TMB in cell-free ctDNA of participants is presented.
Group
Value
95% CI
Pembrolizumab Plus Platinum-doublet Chemotherapy Overall
9
± 11.6
Pembrolizumab Plus Platinum-doublet Chemotherapy Responder
8
± 8.3
Pembrolizumab Plus Platinum-doublet Chemotherapy Non-responder
10
± 13.5
Progression Free Survival (PFS)Secondary· Up to ~36 months
PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first as assessed by investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). The Kaplan-Meier estimate of median PFS using the product-limit (Kaplan-Meier) method for censored data is presented.
Group
Value
95% CI
Pembrolizumab Plus Platinum-doublet Chemotherapy
7.2
5.6 – 9.8
Overall Survival (OS)Secondary· Up to ~36 months
OS is defined as the time from the start of treatment to death due to any cause. The Kaplan-Meier estimate of median PFS using the product-limit (Kaplan-Meier) method for censored data is presented.
Group
Value
95% CI
Pembrolizumab Plus Platinum-doublet Chemotherapy
18.1
13.5 – 25.6
Percentage of Participants Who Experienced One or More Adverse Events (AEs)Secondary· Up to ~31 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced an AE is presented.
Group
Value
95% CI
Pembrolizumab Plus Platinum-doublet Chemotherapy
100
Percentage of Participants Discontinuing Study Intervention Due to an AE.Secondary· Up to ~28 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued the study intervention due to an AE is presented.
Group
Value
95% CI
Pembrolizumab Plus Platinum-doublet Chemotherapy
38.5
Adverse events — posted to ClinicalTrials.gov
Time frame: For All-Cause Mortality: from allocation up to ~36 months. For AEs from start of treatment up to ~31 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Participants with Stage IV nonsquamous non-small cell lung cancer (NSCLC) without prior systemic treatment will be treated with standard of care pembrolizumab combined with platinum-doublet chemotherapy for 4 cycles, then pembrolizumab plus pemetrexed maintenance for up to 31 additional cycles. The platinum doublet would be pemetrexed plus the investigator's choice of either cisplatin or carboplatin. The primary objective is to evaluate if total baseline tumor mutation burden (TMB) in cell-free circulating tumor deoxyribonucleic acid (ctDNA) is predictive of objective response per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by the investigator by estimating the level of association.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
· not yet recruiting
NCT07275216 — Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Stand
· Phase 2
· not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan
· Phase 1, PHASE2
· recruiting
NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors
· Phase 1
· not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
Other recruiting trials for Non-Small Cell Lung Cancer
Currently open trials in the same condition.
NCT07140315 — DK222 Study at Hopkins
· Phase 1
· recruiting
NCT07487883 — Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors
· recruiting
NCT07413757 — CHOICE:Decision Factor of EGFR-TKI in Chinese IV NSCLC
· recruiting
NCT07460999 — Singing Training vs Usual Care 6-18 Months After Surgical Resection for Non-small Cell Lung Cancer (NSCLC)
· NA
· recruiting
NCT07479277 — Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC
· NA
· recruiting
Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005)
· Phase 2
· not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan
· Phase 1, PHASE2
· recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527
· Phase 1
· not yet recruiting
NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M
· Phase 3
· not yet recruiting
NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 22 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03664024.