21 Participants Needed

GT103 + Pembrolizumab for Lung Cancer

Recruiting at 5 trial locations
AL
JC
Overseen ByJeffrey Clarke, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial tests the safety and tolerability of combining GT103, a new drug, with pembrolizumab, an immune-boosting cancer treatment, in adults with advanced lung cancer that has returned or not responded to previous treatments. Pembrolizumab is an immune-boosting treatment that has shown effectiveness in patients with lung cancer and has been tested with other treatments.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does mention that you cannot be on certain anticancer therapies or medications that suppress the immune system beyond a certain level. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug pembrolizumab for lung cancer?

Research shows that pembrolizumab, a drug that helps the immune system fight cancer, has improved outcomes for patients with advanced non-small cell lung cancer, especially when the cancer cells have a high level of a protein called PD-L1.12345

Is the combination of GT103 and Pembrolizumab safe for treating lung cancer?

Pembrolizumab, also known as Keytruda, has been used in various cancer treatments and is generally considered safe, but it can cause side effects like fatigue, cough, and nausea. Serious side effects, such as pneumonitis (lung inflammation), occur in a small percentage of patients. Always discuss potential risks with your healthcare provider.15678

What makes the GT103 + Pembrolizumab treatment for lung cancer unique?

The combination of GT103 with Pembrolizumab is unique because Pembrolizumab is a PD-1 inhibitor that helps the immune system attack cancer cells, and it has shown significant efficacy in treating non-small cell lung cancer. This combination may offer a novel approach by potentially enhancing the immune response against lung cancer compared to using Pembrolizumab alone.125910

Research Team

Jeffrey Melson Clarke, MD | Medical ...

Jeffrey M. Clarke

Principal Investigator

Duke Cancer Institute

Eligibility Criteria

Adults over 18 with Stage III-IV recurrent or metastatic NSCLC, who have relapsed or are refractory to immunotherapy and possibly chemotherapy. They must have adequate organ function, not be pregnant or breastfeeding, use contraception if of childbearing potential, and cannot have other conditions that might interfere with the trial.

Inclusion Criteria

Age ≥ 18 years at the time of consent.
Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 14 days prior to C1D1.
Females of childbearing potential and males must be willing to abstain from heterosexual intercourse or to use an effective method(s) of contraception as outlined in protocol.
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Exclusion Criteria

Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion, are not eligible for this trial.
Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
You cannot tolerate pembrolizumab or other drugs that help the immune system fight cancer.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-in

A safety lead-in phase to determine the safest dose of GT103 in combination with pembrolizumab

6 months
Regular visits as per protocol

Treatment

Participants receive GT103 and pembrolizumab intravenously on Day 1 of a 21-day cycle

3 years
Every 21 days (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

Treatment Details

Interventions

  • GT103
  • Pembrolizumab
Trial OverviewThe trial is testing GT103 in combination with Pembrolizumab for safety and effectiveness in treating NSCLC. It includes an initial phase to determine the safest dose followed by treatment of up to 60 patients at this dose level.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Experimental GroupExperimental Treatment2 Interventions
Pembrolizumab will be given intravenously on Day 1 of the 21 day cycle (For all cycles). GT103 dose will be determined by the safety lead in prior to the study. Dosing calculations should be based on actual body weight where applicable. It will be taken intravenously on Day 1 of the 21 day cycle (For all cycles).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jeffrey Clarke

Lead Sponsor

Trials
4
Recruited
110+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Grid Therapeutics

Collaborator

Trials
1
Recruited
20+

Findings from Research

Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.
Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]
A 68-year-old patient with stage IV lung adenocarcinoma showed an unexpected positive response to paclitaxel after failing treatment with pembrolizumab, an anti-PD-1 immunotherapy.
The patient experienced a response duration of over fourteen months with paclitaxel, suggesting that combining or sequencing chemotherapy with immunotherapy may enhance treatment effectiveness in certain cases.
[Prolonged response with paclitaxel after immunotherapy by pembrolizumab in lung cancer].Zapata, E., Mennecier, B., Leduc, C., et al.[2017]
In a study involving 1033 patients with advanced non-small-cell lung cancer (NSCLC), pembrolizumab significantly improved overall survival compared to docetaxel, with a hazard ratio of 0.66, indicating a 34% reduction in the risk of death.
The effectiveness of pembrolizumab was consistent across both archival and newly collected tumor samples, with better outcomes observed in patients with higher PD-L1 expression (TPS ≥50%), showing hazard ratios of 0.64 and 0.40 for overall survival, respectively.
Use of archival versus newly collected tumor samples for assessing PD-L1 expression and overall survival: an updated analysis of KEYNOTE-010 trial.Herbst, RS., Baas, P., Perez-Gracia, JL., et al.[2023]

References

Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
[Prolonged response with paclitaxel after immunotherapy by pembrolizumab in lung cancer]. [2017]
Use of archival versus newly collected tumor samples for assessing PD-L1 expression and overall survival: an updated analysis of KEYNOTE-010 trial. [2023]
Pembrolizumab Shows Promise for NSCLC. [2015]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond. [2022]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
Perioperative outcomes of pulmonary resection after neoadjuvant pembrolizumab in patients with non-small cell lung cancer. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Acute myelomonocytic leukemia during pembrolizumab treatment for non-small cell lung cancer: A case report. [2020]