Pembrolizumab + Sacituzumab Govitecan for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Tartu University Hospital-Radiotherapy and oncology ( Site 0620), Tartu, EstoniaNon-Small Cell Lung CancerPembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial compares pembrolizumab alone with pembrolizumab plus a different drug to see how well they work in treating metastatic non-small cell lung cancer.

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

2 Primary · 16 Secondary · Reporting Duration: Up to approximately 48 months

Month 48
Pain
Malignant Neoplasms
Dyspnea
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Change from Baseline in Role Functioning (Items 6-7) Combined Score on the EORTC QLQ-C30
Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)
Month 34
Objective Response (OR)
Progression-Free Survival (PFS)
Month 48
Duration of Response (DOR)
Number of Participants Who Discontinue Study Treatment Due To an AE
Number of Participants Who Experience an Adverse Event (AE)
Overall Survival (OS)
Pain
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13
Dyspnea
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
TTD in Role Functioning (Items 6-7) Combined Score on the EORTC QLQ-C30
Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

Pembrolizumab + Sacituzumab Govitecan
1 of 2
Pembrolizumab
1 of 2

Experimental Treatment

614 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab + Sacituzumab Govitecan · No Placebo Group · Phase 3

Pembrolizumab + Sacituzumab GovitecanExperimental Group · 2 Interventions: Pembrolizumab, Sacituzumab Govitecan · Intervention Types: Biological, Biological
Pembrolizumab
Biological
Experimental Group · 1 Intervention: Pembrolizumab · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2200

Trial Logistics

Trial Timeline

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

Who is running the clinical trial?

Gilead SciencesIndustry Sponsor
1,030 Previous Clinical Trials
774,257 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,711 Previous Clinical Trials
4,967,148 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,656 Previous Clinical Trials
7,956,990 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least 3 more months.

Frequently Asked Questions

What is the current size of the cohort participating in this trial?

"Accurate. Information posted to clinicaltrials.gov confirms that this medical trial is currently recruiting patients, having first been uploaded on February 10th 2023 and more recently edited January 13th 2023. Approximately 614 participants must be found from a single site for the project to move forward." - Anonymous Online Contributor

Unverified Answer

Has the combination of Pembrolizumab and Sacituzumab Govitecan been validated by the FDA?

"Pembrolizumab + Sacituzumab Govitecan is estimated to be of high safety, as evidenced by its 3 rating on our scale. The Phase 3 trial has generated data that both confirms efficacy and bolsters the drug's security profile." - Anonymous Online Contributor

Unverified Answer

Are there any ongoing enrolment opportunities in this experiment?

"Affirmative. According to the data hosted on clinicaltrials.gov, this medical test is presently searching for participants and was first posted in February 10th 2021 while most recently updated on January 13th 2021. The project demands 614 patients from one location." - Anonymous Online Contributor

Unverified Answer

What is the intended outcome of this experiment?

"The primary outcome for this clinical trial, which is expected to span up to 34 months, will be Overall Survival (OS). Secondary outcomes include Objective Response (OR) and Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30), as well as Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.