Pembrolizumab for Lung Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Lung Cancer+3 More
Pembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effects of two cancer treatments - pembrolizumab and lenvatinib vs. docetaxel - on overall survival and progression-free survival in patients with metastatic non-small cell lung cancer who have progressed after initial platinum doublet chemotherapy and treatment with one prior anti-PD-1/PD-L1 monoclonal antibody.

Eligible Conditions
  • Lung Cancer
  • Malignant Neoplasms

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

2 Primary · 15 Secondary · Reporting Duration: Up to ~48 months

Baseline and Week 12
Change from Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score
Change from Baseline in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score
Change from Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 31) Scale Score
Change from Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score
Up to ~18 months
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Docetaxel
Up to ~36 months
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Lenvatinib Monotherapy
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Up to ~48 months
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Number of Participants Discontinuing Study Treatment Due to an AE
Number of Participants Experiencing an Adverse Event (AE)
Overall Survival (OS)
Time to True Deterioration (TTD) in EORTC QLQ-C30 Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score
Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score
Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score
Time to True Deterioration (TTD) in EORTC QLQ-LC13 Cough (Item 31) Scale Score

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

3 Treatment Groups

Docetaxel
1 of 3
Lenvatinib Monotherapy
1 of 3
Pembrolizumab+Lenvatinib
1 of 3
Active Control
Experimental Treatment

405 Total Participants · 3 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 3

Lenvatinib Monotherapy
Drug
Experimental Group · 1 Intervention: Lenvatinib · Intervention Types: Drug
Pembrolizumab+LenvatinibExperimental Group · 2 Interventions: Lenvatinib, Pembrolizumab · Intervention Types: Drug, Biological
Docetaxel
Drug
ActiveComparator Group · 1 Intervention: Docetaxel · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to ~48 months

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,578,799 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,653 Previous Clinical Trials
4,953,202 Total Patients Enrolled
Eisai Inc.Industry Sponsor
504 Previous Clinical Trials
144,567 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,618 Previous Clinical Trials
7,936,420 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Has platinum-based chemotherapy for metastatic disease.
You have been treated with one or more anti-PD-1/PD-L1 mAbs
You have at least 1 measurable lesion by CT or MRI per RECIST 1.1, as determined by the local site assessment.
The tumor must be archived from the initial diagnosis of NSCLC and prior to receiving immunotherapy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: October 5th, 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.