Lete-cel for Lung Cancer

Phase-Based Estimates
GSK Investigational Site, Iowa City, IA
Lung Cancer+2 More
Lete-cel - Drug
All Sexes
Eligible conditions
Lung Cancer

Study Summary

This study is evaluating whether a combination of a monoclonal antibody and genetically modified white blood cells may help treat cancer.

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Eligible Conditions

  • Lung Cancer
  • Lung Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Cancer
  • Neoplasms

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Lete-cel will improve 3 primary outcomes and 8 secondary outcomes in patients with Lung Cancer. Measurement will happen over the course of Up to 106 weeks post-dose.

Week 106
AEs and SAEs leading to dose delays and/or withdrawals
Area under the time curve from zero to time t (AUC[0 to t]) of GSK3377794
Area under the time curve from zero to time t (AUC[0 to t]) of lete-cel
Disease Control Rate (DCR)
Duration of Response (DoR)
Maximum transgene expansion (Cmax) for lete-cel
Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESIs) based on severity
Overall response rate (ORR)
Progression-Free Survival (PFS)
Time to Cmax (Tmax) for lete-cel
Time to Response (TTR)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

3 Treatment Groups

No Control Group
Arm A: lete-cel monotherapy

This trial requires 54 total participants across 3 different treatment groups

This trial involves 3 different treatments. Lete-cel is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm A: lete-cel monotherapyIn Arm A, participants with NSCLC (lacking actionable genetic aberrations) will receive lete-cel monotherapy. Participants who subsequently progress by Week 25 will be offered pembrolizumab.
Arm C: lete-cel plus pembrolizumabIn Arm C, participants with NSCLC (with actionable genetic aberrations) will receive lete-cel followed by pembrolizumab.
Arm B: lete-cel plus pembrolizumabIn Arm B, participants with NSCLC (lacking actionable genetic aberrations) will receive lete-cel followed by pembrolizumab.
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 106 weeks post-dose
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 106 weeks post-dose for reporting.

Closest Location

GSK Investigational Site - Iowa City, IA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You are at least 18 years old on the day of signing informed consent. show original
You have adequate organ function and blood cell counts. show original
Histologically or cytologically diagnosed unresectable Stage IIIb or Stage IV NSCLC.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Participant is positive for any of the following alleles: human leukocyte antigen (HLA)-A*02:01, HLA-A*02:05, and a) or HLA-A*02:06 by a validated test.
Participant's tumor meets the pre-defined threshold for expression of NY-ESO-1 and/or LAGE-1a.
Predicted life expectancy that is >=24 weeks from leukapheresis.
You have a left ventricular ejection fraction of 45% or greater. show original
Prior therapies prior to lymphodepletion: a) All participants with NSCLC lacking actionable genetic aberrations, per National Comprehensive Cancer Network (NCCN) guidelines (Arms A and B), need to have received at least one line of programmed death protein 1/programmed death protein 1 ligand (PD-1/PD-L1) checkpoint blockade therapy. For participants in the metastatic setting, PD-1/PD-L1 checkpoint blockade therapy must have been received either alone, in combination or sequentially with platinum-containing chemotherapy. OR b) All participants with NSCLC with actionable genetic aberrations, per NCCN guidelines (Arm C only), should have received appropriate targeted therapy following NCCN or equivalent country-level guidelines.
You have a disease that is progressing. show original

Patient Q&A Section

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

What is lung cancer?

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Lung cancer is a cancer that forms in the tissues lining the lungs, and can be detected in people who have unexplained unexplained cough. It causes problems, often very serious, and can be diagnosed by medical imaging. It is one of the most life-destroying cancers.

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How many people get lung cancer a year in the United States?

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For every death in the United States, it is estimated 5.4 deaths from [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) occur, and in every 13 deaths from lung cancer, 6 people develop the disease from that cancer. This means that annually, 1.4 million people in the US develop lung cancer as part of a fatal disease course. These statistics provide important information for the national lung cancer screening effort in the US.

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Can lung cancer be cured?

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Current clinical research efforts should redirect efforts to development of more effective anticancer drugs. With these developments, we could expect improvements in patients' long-term survival.

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What are common treatments for lung cancer?

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Common treatment for [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) is based on staging. As lung cancer is a disease with aggressive behaviour it is treated with a wide range of therapies including surgery, chemotherapy and radiotherapy. For Stage I–III the treatment of lung cancer is also very different, depending on the stage of the disease. Patients with localized cancers are treated with surgery alone or in combination with radiotherapy and chemotherapy. For Stage IV the treatment of lung cancer in terms of the therapy is tailored to the disease and the patient.\n

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What are the signs of lung cancer?

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Most cases of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) are asymptomatic. Patients with chronic inflammatory conditions, such as COPD, are more likely to present with symptoms. Older patients, particularly men, are more likely to be diagnosed with curable, non-smokers cancers.

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What causes lung cancer?

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The risk factors for [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) vary by cancer site. Smoking is a significant risk factor for squamous cell carcinoma of the lung. Occupation and radon exposure are significant risk factors for small cell carcinoma of the lung and adenocarcinoma of the lung, while a history of ionizing radiation and working in a coal mine are risk factors for small cell carcinoma of the lung. Asbestos exposure is an obvious risk factor for lung cancer. Gender-related factors, such as female sex, a history or family history of colon cancer, and a history of breast cancer, seem to increase the risk for adenocarcinoma of the lung.

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What does lete-cel usually treat?

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A small minority of people with early-stage lung cancer receive palliative chemotherapy at the end of life. More research is needed to determine the appropriateness of palliative chemotherapy, including which treatments should be offered and who should undergo first line (neoadjuvant first line) chemotherapy for NSCLC.

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How does lete-cel work?

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From an institutional perspective, a combination of an in-hospital clinical model along with telemedicine-facilitated outpatient follow-up may be a promising approach to reduce hospital utilization in the management of patients with lung cancer.

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Have there been other clinical trials involving lete-cel?

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The clinical results of this study indicate that lete-cel has the potential to be effective therapy for patients with non-small-cell lung cancer. In a recent study, findings warrant a confirmation of these results by further randomized controlled trials.

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Is lete-cel safe for people?

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Participants treated with lete-cel exhibited an improvement of quality of life with respect to pain, dyspnea, fatigue, and appetite, even those with severe disease. We conclude that lete-cel shows promise as a treatment for an array of advanced solid tumors.

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What are the latest developments in lete-cel for therapeutic use?

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It seems that with a few exceptions (such as cisplatin-based combination chemotherapy), current chemotherapy regimens are not yet able to fully kill tumor cells, which may result in relapse. Therefore, it is tempting to suggest a combination of new chemotherapeutic medications to increase the response.

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Does lung cancer run in families?

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Results from a recent paper show that patients with familial lung cancer are slightly less likely to have symptoms suggestive of carcinomatosis, a poor prognosis or advanced stage of disease. We found no evidence to suggest that lung cancer runs in families in the Caucasian population. However, lung cancer tends to occur more often in smokers, and smoking rates increase with family history of lung cancer.

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