Experimental Group for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
Duke Cancer Institute, Durham, NCNon-Small Cell Lung Cancer+2 MorePembrolizumab - Drug
All Sexes
What conditions do you have?

Study Summary

This trial assesses safety & effectiveness of an experimental drug combo to treat advanced lung cancer in adults. Safety lead-in of 10-20 patients, then 50-60 total.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Non-small Cell Lung Cancer (NSCLC), Recurrent

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: 4 years

3 years
Objective Response Rate (ORR)
4 years
Overall Survival (OS)
Progression Free Survival (PFS)
6 months
Assess the Frequency and Severity of Adverse Events
Characterize PK Profile: Area Under the Plasma Concentration vs Time Curve (AUC)
Characterize PK Profile: Peak Plasma Concentration (Cmax)
Characterize PK Profile: T1/2 of GT103 in combination with Pembrolizumab
Characterize PK Profile: Tmax of GT103 in combination with Pembrolizumab

Trial Safety

Safety Progress

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

Trial Design

1 Treatment Group

Experimental Group
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Experimental Group · No Placebo Group · Phase 2

Experimental GroupExperimental Group · 2 Interventions: Pembrolizumab, GT103 · Intervention Types: Drug, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years

Who is running the clinical trial?

Jeffrey ClarkeLead Sponsor
3 Previous Clinical Trials
92 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,711 Previous Clinical Trials
4,967,447 Total Patients Enrolled
Grid TherapeuticsUNKNOWN
Jeffrey Clarke, MDPrincipal InvestigatorDuke Cancer Institute
4 Previous Clinical Trials
52 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 14 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Rewritten Criterion: You have received immunotherapy in the past, but it did not work for you. You may have received other treatments, such as chemotherapy. However, you cannot have had more than two treatments before this one (excluding oral targeted therapy).

Frequently Asked Questions

Is this investigation accepting new participants?

"According to the current information on clinicaltrials.gov, this medical experiment is actively seeking participants with postings first made on February 17th 2023 and most recently updated February 23rd." - Anonymous Online Contributor

Unverified Answer

Has the FDA approved Experimental Group's products for use?

"Our team at Power approximated the safety of Experimental Group with a score of 2, as this is only in Phase 2. Thus far, there has been data to support its safety but not its efficacy." - Anonymous Online Contributor

Unverified Answer

Is there a finite limit to the number of volunteers taking part in this clinical experiment?

"Affirmative. The clinical trial, posted on February 17th 2023 and most recently revised on the 23rd of the same month, is actively seeking participants according to data hosted by clinicaltrials.gov. In total, 50 individuals are being recruited from 1 medical centre." - Anonymous Online Contributor

Unverified Answer

What outcomes is this research attempting to accomplish?

"This 3-year clinical trial is designed to measure the incidence and magnitude of adverse events. Pharmacokinetic analysis will be used to assess three secondary outcomes: 1) The time it takes for GT103 to reach its peak concentration when administered with Pembrolizumab (Tmax); 2) The maximum serum concentration of GT103 after administration in combination with Pembrolizumab (Cmax); and, 3) Area under the plasma concentration vs time curve (AUC)." - 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.