What side effects are associated with this type of intervention?

Common treatments for NSCLC, particularly those involving PD-1 inhibitors like pembrolizumab, often result in a range of side effects. Pembrolizumab monotherapy is associated with severe (≥grade 3) treatment-related adverse effects in about 27% of patients, with any-grade pneumonitis occurring in 5.8% and severe pneumonitis in 2.6%. Atezolizumab, another PD-L1 inhibitor, has grade ≥3 adverse events in approximately 30% of patients, including pneumonia, chronic obstructive pulmonary disease, and pneumonitis. Cemiplimab, also a PD-1 inhibitor, shows grade ≥3 toxicities in 28% of patients. When combined with chemotherapy, these inhibitors can increase the incidence of severe side effects, such as neutropenia, febrile neutropenia, and hypertension.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has received FDA approval for the treatment of advanced NSCLC, particularly in patients with high PD-L1 expression. It has been approved both as monotherapy and in combination with chemotherapy. Other similar immunotherapies include nivolumab (another PD-1 inhibitor) and atezolizumab (a PD-L1 inhibitor), which have also been approved for NSCLC. These approvals are based on clinical trials demonstrating improved overall survival and progression-free survival compared to chemotherapy alone. Combination therapies, such as pembrolizumab with platinum-doublet chemotherapy, have shown significant benefits in terms of response rates and duration of response.

What other types of research exist?

Promising alternatives to GT103 and Pembrolizumab for NSCLC patients include: 1) Nivolumab (PD-1 inhibitor) in combination with chemotherapy, which has shown improved progression-free survival in clinical trials. 2) Atezolizumab (PD-L1 inhibitor) combined with chemotherapy, which has demonstrated efficacy in both squamous and non-squamous NSCLC. 3) Durvalumab (PD-L1 inhibitor) following chemoradiotherapy for stage III NSCLC, which has shown significant improvement in overall survival. These alternatives offer different mechanisms and combination strategies that may be beneficial for NSCLC patients.

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Monoclonal Antibodies

GT103 + Pembrolizumab for Lung Cancer

Phase 2

Waitlist Available

Led By Jeffrey Clarke, MD

Research Sponsored by Jeffrey Clarke

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While specific side effects for GT103 aren't listed, Pembrolizumab can cause immune system reactions affecting organs, fatigue, infusion-related reactions like fever or chills, skin rash, digestive issues such as diarrhea or liver inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess the Frequency and Severity of Adverse Events

Objective Response Rate (ORR)

Secondary study objectives

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

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pembrolizumab, a PD-1 inhibitor, blocks the PD-1 pathway that cancer cells use to evade the immune system, thereby reactivating T-cells to recognize and attack cancer cells. GT103, though its mechanism is unspecified, is being studied in combination with pembrolizumab, suggesting it may also modulate the immune response. These mechanisms are important for NSCLC patients as they leverage the body's immune system to target cancer cells, potentially offering more effective and less toxic treatment options compared to traditional chemotherapy.

A Review of Recent Advances in the Treatment of Elderly and Poor Performance NSCLC.