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Pembrolizumab for Non-Small Cell Lung Cancer

IRCCS Istituti Fisioterapicic Ospitalieri - Istituto Nazionale Tumori Regina Elena, Rome, Italy
Non-Small Cell Lung CancerPembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new combination therapy for advanced or metastatic non-small-cell lung cancer (NSCLC) that has not responded to other treatments. The primary objectives are to assess the objective response rate (ORR) and to determine the recommended Phase 2 dose (RP2D) of the new therapy.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Hu5F9-G4
1
GI-101 + Pembrolizumab

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Up to 24 Months

Day 21
Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) per Dose Level in the Safety Run-in Cohorts
Month 24
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Up to 22 Months
Objective Response Rate as Assessed by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Up to 24 Months
Disease Control Rate as Assessed by IRC per RECIST Version 1.1
Duration of Response as Assessed by IRC per RECIST Version 1.1
Overall Survival
Progression-free Survival as Assessed by IRC per RECIST Version 1.1

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Quality-of-Life Assessment
1
Hu5F9-G4
1
GI-101 + Pembrolizumab

Side Effects for

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

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

7 Treatment Groups

SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C)
1 of 7
SG + Pembrolizumab + Cisplatin (Cohort E)
1 of 7
SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D)
1 of 7
Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A)
1 of 7
SG + Pembrolizumab (Cohort B)
1 of 7
SG + Pembrolizumab + Carboplatin Safety Run-in
1 of 7
SG + Pembrolizumab + Cisplatin Safety Run-in (Optional)
1 of 7

Experimental Treatment

224 Total Participants · 7 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C)Experimental Group · 4 Interventions: Sacituzumab Govitecan-hziy (SG), Pembrolizumab, Carboplatin, Cisplatin · Intervention Types: Drug, Drug, Drug, Drug
SG + Pembrolizumab + Cisplatin (Cohort E)Experimental Group · 3 Interventions: Sacituzumab Govitecan-hziy (SG), Pembrolizumab, Cisplatin · Intervention Types: Drug, Drug, Drug
SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D)Experimental Group · 4 Interventions: Sacituzumab Govitecan-hziy (SG), Pembrolizumab, Carboplatin, Cisplatin · Intervention Types: Drug, Drug, Drug, Drug
Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A)Experimental Group · 2 Interventions: Sacituzumab Govitecan-hziy (SG), Pembrolizumab · Intervention Types: Drug, Drug
SG + Pembrolizumab (Cohort B)Experimental Group · 2 Interventions: Sacituzumab Govitecan-hziy (SG), Pembrolizumab · Intervention Types: Drug, Drug
SG + Pembrolizumab + Carboplatin Safety Run-inExperimental Group · 3 Interventions: Sacituzumab Govitecan-hziy (SG), Pembrolizumab, Carboplatin · Intervention Types: Drug, Drug, Drug
SG + Pembrolizumab + Cisplatin Safety Run-in (Optional)Experimental Group · 3 Interventions: Sacituzumab Govitecan-hziy (SG), Pembrolizumab, Cisplatin · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacituzumab Govitecan-hziy (SG)
2012
Completed Phase 2
~520
Pembrolizumab
2017
Completed Phase 3
~2200
Carboplatin
2014
Completed Phase 3
~6500
Cisplatin
2013
Completed Phase 3
~1920

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,037 Previous Clinical Trials
776,066 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,735 Previous Clinical Trials
4,973,250 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
331 Previous Clinical Trials
184,767 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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References

Frequently Asked Questions

Has Pembrolizumab been officially sanctioned by the Food and Drug Administration?

"Pembrolizumab's safety is rated 2, as it has only undergone clinical testing to ascertain its security but not yet efficacy." - Anonymous Online Contributor

Unverified Answer

How many physical sites are offering this research opportunity?

"This ground-breaking research is conducted across 15 sites in total, the three major centres being Stanford Cancer Institute (Stanford, Illinois), UC Irvine Medical Center (Orange, North Carolina) and Orchard Healthcare Research Inc. (Skokie, Georgia)." - Anonymous Online Contributor

Unverified Answer

What is the upper limit for patients participating in this trial?

"164 eligible patients are required to join this trial, with enrolment occurring at Stanford Cancer Institute (Stanford, Illinois) and UC Irvine Medical Center (Orange County, North Carolina)." - Anonymous Online Contributor

Unverified Answer

Are there still opportunities for participants in this experiment?

"This trial is currently open to potential participants. Clinicaltrials.gov indicates that it was first announced on May 30th 2022 and last revised on November 16th 2022." - 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.

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