Pembrolizumab for Carcinoma, Non-Small-Cell Lung

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Carcinoma, Non-Small-Cell Lung+2 More
Pembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effectiveness of a new cancer drug, datopotamab deruxtecan, when used with pembrolizumab versus pembrolizumab alone in patients with advanced lung cancer.

Eligible Conditions
  • Carcinoma, Non-Small-Cell Lung
  • Malignant Neoplasms

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 10 Secondary · Reporting Duration: Up to 53 months

Month 53
Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA
Month 32
Duration of Response by BICR and Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Month 32
Time to Response by BICR and Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Month 53
Overall Survival in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Month 32
Disease Control Rate by BICR and Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Objective Response Rate by Blinded Independent Central Review in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Objective Response Rate by Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Progression-free Survival Based on Blinded Independent Central Review in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Progression-free Survival by Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Month 53
Progression-free Survival 2 in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Time to Deterioration in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Up to 53 months
Number of Participants With Treatment-emergent Adverse Events (TEAE) Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Pembrolizumab Second Course
100%Urinary tract infection
100%Parkinsonism
100%Inappropriate antidiuretic hormone secretion
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Urinary tract infection with 100%, Parkinsonism with 100%, Inappropriate antidiuretic hormone secretion with 100%.

Trial Design

2 Treatment Groups

Pembrolizumb
1 of 2
Pembrolizumab + Datopotamab Deruxtecan (Dato-DXd)
1 of 2

Active Control

Experimental Treatment

740 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 3

Pembrolizumab + Datopotamab Deruxtecan (Dato-DXd)Experimental Group · 2 Interventions: Pembrolizumab, Datopotamab Deruxtecan · Intervention Types: Drug, Drug
Pembrolizumb
Drug
ActiveComparator Group · 1 Intervention: Pembrolizumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2580

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 53 months

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,656 Previous Clinical Trials
4,953,418 Total Patients Enrolled
146 Trials studying Carcinoma, Non-Small-Cell Lung
43,442 Patients Enrolled for Carcinoma, Non-Small-Cell Lung
Daiichi Sankyo, Inc.Lead Sponsor
356 Previous Clinical Trials
340,814 Total Patients Enrolled
27 Trials studying Carcinoma, Non-Small-Cell Lung
7,270 Patients Enrolled for Carcinoma, Non-Small-Cell Lung
AstraZenecaIndustry Sponsor
3,958 Previous Clinical Trials
91,809,580 Total Patients Enrolled
263 Trials studying Carcinoma, Non-Small-Cell Lung
91,495 Patients Enrolled for Carcinoma, Non-Small-Cell Lung
Global Clinical LeaderStudy DirectorDaiichi Sankyo, Inc.
150 Previous Clinical Trials
74,647 Total Patients Enrolled
19 Trials studying Carcinoma, Non-Small-Cell Lung
5,137 Patients Enrolled for Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are eligible for inclusion in the study if you meet all inclusion criteria within 28 days of randomization.
You have documented negative test results for EGFR, ALK, and ROS1 actionable genomic alterations based on analysis of tumor tissue.
You have provided a formalin-fixed tumor tissue sample for the measurement of trophoblast cell surface protein 2 (TROP2) protein expression and for the assessment of other exploratory biomarkers.
Tumor has high programmed death receptor-1 (PD-L1) expression (TPS ≥50%) as determined by PD-L1 IHC 22C3 pharmDx assay by central testing (minimum of 6 slides).
You have not had an adequate treatment washout period before Cycle 1 Day 1.
You have a measurable disease based on local imaging assessment using RECIST Version 1.1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 12th, 2021

Last Reviewed: November 2nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.