Tislelizumab for Non-Small Cell Lung Carcinoma (NSCLC)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Hôpital Européen Georges Pompidou, Paris, France
Non-Small Cell Lung Carcinoma (NSCLC)+4 More
Tislelizumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Ociperlimab With Tislelizumab and Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer

See full description

Eligible Conditions

  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Advanced Non Small Cell Lung Cancer (NSCLC)
  • Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Non-Small Cell Lung Carcinoma (NSCLC)

Study Objectives

This trial is evaluating whether Tislelizumab will improve 1 primary outcome and 6 secondary outcomes in patients with Non-Small Cell Lung Carcinoma (NSCLC). Measurement will happen over the course of 90 days (±14) after last dose.

Day 90
Number of Participants Experiencing Adverse Events (AEs)
Month 12
Immunogenic responses to ociperlimab and tislelizumab, evaluated through detection of anti-drug antibodies (ADAs).
Serum concentrations of ociperlimab and tislelizumab at prespecified timepoints
Month 30
Duration of Response (DoR) As Assessed by Investigators
Overall Response Rate (ORR) as Assessed by Investigators
Overall Survival (OS)
Progression-free Survival (PFS) as Assessed by Investigators

Trial Safety

Safety Progress

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

Other trials for Non-Small Cell Lung Carcinoma (NSCLC)

Trial Design

2 Treatment Groups

Arm A: Ociperlimab + tislelizumab histology-based chemotherapy
1 of 2
Arm B: Placebo + tislelizumab + histology-based chemotherapy
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 270 total participants across 2 different treatment groups

This trial involves 2 different treatments. Tislelizumab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm A: Ociperlimab + tislelizumab histology-based chemotherapy
Arm B: Placebo + tislelizumab + histology-based chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 30 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to approximately 30 months for reporting.

Closest Location

Texas Oncology (Tyler) - USOR - Tyler, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Non-Small Cell Lung Carcinoma (NSCLC) or one of the other 4 conditions listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologically or cytologically documented locally advanced or recurrent NSCLC that is not eligible for curative surgery and/or definitive radiotherapy, with or without chemotherapy, or metastatic non-squamous or squamous NSCLC.
No prior systemic therapy for locally advanced or metastatic squamous or non-squamous NSCLC, including but not limited to chemotherapy or targeted therapy. Patients who have received prior neoadjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for nonmetastatic disease must have experienced a disease-free interval of ≥ 6 months from the last dose of chemotherapy and/or concurrent radiotherapy prior to randomization.
Archival tumor tissue or fresh biopsy (if archival tissue is not available) for the determination of PD-L1 levels and retrospective analyses of other biomarkers. Only patients who have evaluable PD-L1 results are eligible.
At least one measurable lesion by the investigator per RECIST v1.1.
.
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
Key

Patient Q&A Section

What is the primary cause of lung cancer?

"The development of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) has a complex etiology involving interactions between genetic predisposition, environmental factors, and immunological factors. Genetic predisposition plays an important role in the development of lung cancer, and the relative importance of genetic factors varies according to ethnicity and smoking habits. The environment may influence the behavior of cigarette smokers, but the exact pathway leading to lung cancer is complicated. Immunological factors include exposure to infectious agents, such as viruses, bacteria, and parasites, and to certain chemicals. Complicating factors involve cancer therapy, radiation therapy, occupational exposures, and other environmental exposures. In addition to these main causes, people can develop lung cancer under circumstances that do not fit into the above categories. For example, nutritional deficiency can induce lung cancer." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in tislelizumab for therapeutic use?

"The updated data support the use of anti-PD-1 antibody tislelizumab as a therapeutic agent for patients with advanced NSCLC. The available clinical data on this drug are encouraging and warrant further evaluation of its efficacy and safety in patients with NSCLC." - Anonymous Online Contributor

Unverified Answer

What are common treatments for lung cancer?

"Lung cancer is an aggressive disease that is difficult to manage because of its rapid growth and metastases at distant sites. Chemotherapy is effective for early-stage tumors and for non-small cell lung cancer (NSCLC), but the optimal chemotherapy regimen is not yet clear. Radiotherapy is also important for the control of localized disease in NSCLC; however, the optimum radiation dose is still under investigation. Surgery is often indicated for certain indications, such as tumor invasion into major blood vessels or surrounding structures, or locally recurrent tumors. In some cases surgical resection with or without adjuvant chemotherapy may be curative. A targeted approach to therapies is in development for patients who have specific mutations of their cancer cells." - Anonymous Online Contributor

Unverified Answer

What is the latest research for lung cancer?

"Larger randomized trials are needed to confirm the role of EGFR mutation testing, especially its value in selecting patients for targeted therapies; to study the effectiveness of different treatment strategies in elderly patients with SCLC; to evaluate novel biomarkers designed to identify the subgroup of surgically resectable NSCLC patients who might benefit from neoadjuvant chemotherapy before surgery; and to investigate other novel treatments currently under investigation." - Anonymous Online Contributor

Unverified Answer

Does tislelizumab improve quality of life for those with lung cancer?

"Tislelizumab seems to have a significant effect on QoL in patients with NSCLC. However, long-term follow-up data are needed to evaluate its potential effects on QoL over time." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of tislelizumab?

"No dose-limiting toxicities occurred during treatment with tislelizumab, suggesting that doses of up to 30 mg/kg may be used safely. The most common adverse reactions included headache, nausea, fatigue, asthenia, rashes, infusion site reactions, leukopenia and elevated transaminases. Allergic reactions were infrequent." - Anonymous Online Contributor

Unverified Answer

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

"Lung cancer incidence rates were higher than expected in this population-based study. The mean annual incidence rate of lung cancer was 2.6 per 100,000 population; however, the incidence rate varied considerably by race and sex. A high proportion of cases occurred among men in their 60s and 80s. In addition, our findings suggest that age-adjusted lung cancer mortality has declined over time." - Anonymous Online Contributor

Unverified Answer

Is tislelizumab typically used in combination with any other treatments?

"This survey showed that Tislelizumab was most commonly given as a monotherapy or in combination with chemotherapy and targeted therapy drugs. This data suggests that Tislelizumab has been used throughout its history for treatment of certain malignancies. The processes of drug development should be explored further so that clinicians can use this information to decide whether Tislelizumab is an appropriate drug for their patients." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving tislelizumab?

"Results from a recent paper demonstrated that this agent had no effect on OS when compared to placebo and was not superior to placebo on PFS. Tislelizumab did not demonstrate clear efficacy in lung cancer." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating lung cancer?

"The incidence of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) is increasing dramatically worldwide. Tumor biology is changing, as our knowledge of the mechanisms behind the growth of tumors increases. Lung cancer continues to have a dismal prognosis, with a five year survival rate of less than 15%. There are many reasons why advances in treatment have been slow. First, screening programs are not widespread; second, diagnosis is often delayed until the disease has reached an advanced stage; third, there are many differences between cancer subtypes; and fourth, there are no improvements in the quality of life of patients after definitive treatment of the disease." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for lung cancer?

"Survival rates for lung cancer varies greatly depending on patient age and race/ethnicity. Patients aged 65+ years, regardless of race/ethnicity, had similar 5-year survival rates when compared to patients younger than 65. Younger black men had lower 5-year survival rates than older white men or blacks; however, mortality rates were comparable among all age groups. Results from a recent clinical trial suggest that while lung cancer incidence may be increasing in the general population, these disparities persist." - 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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