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A Study to Investigate Treatment Patterns and Effectiveness of Tislelizumab in European Patients With Resectable or Advanced Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC)

ConditionsAdvanced Non-Small Cell Lung CancerExtensive-Stage Small Cell Lung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeOne Medicines

About this trial

The purpose of this study is to collect real-world data on treatment patterns and clinical outcomes in European patients receiving tislelizumab in routine clinical practice

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants or their legal representative must sign written inform consent form (ICF)

Participants receive tislelizumab as part of routine clinical practice as determined by the treating physician per standard of care and in accordance with the SmPC, within the approved indications in the 4 cohorts described.

Disqualifiers

Participants who are unable to understand all implications of study participation.

Participants who have contraindications for treatment with tislelizumab in the investigator's opinion or have any contraindication as listed in the SmPC of tislelizumab.

Participants who are deemed ineligible according to the investigator's opinion and the SmPC of tislelizumab.

Trial population

Participants with Resectable or Advanced Non-Small Cell Lung Cancer and Extensive-Stage Small Cell Lung Cancer in Europe receiving Tislelizumab in routine clinical practice

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Tislelizumab

    Drug

    Administered as part of routine clinical practice as determined by the treating physician in accordance with the summary of product characteristics (SmPC) and local standard of care

Treatment groups

440 Participants
are divided into 4 treatment groups
Group A: Cohort 1: Resectable NSCLC at High Risk of Recurrence1 intervention
Group B: Cohort 2: Non-squamous NSCLC and Programmed Death Ligand 1 (PD-L1) ≥ 50%1 intervention
Group C: Cohort 3: Locally Advanced or Metastatic Squamous NSCLC1 intervention
Group D: Cohort 4: Extensive-Stage-SCLC1 intervention

Trial outcomes

Primary outcomes

1

Time from Diagnosis to First Dose

Time frame
From date of first tislelizumab administration up to 30 months
2

Duration of Treatment

Time frame
From date of first tislelizumab administration up to 30 months
3

Number of Participants with Dose Modifications

Time frame
From date of first tislelizumab administration up to 30 months
4

Number of Participants with Treatment Discontinuation

Time frame
From date of first tislelizumab administration up to 30 months

Secondary outcomes

1

Real-world Pathological Complete Response (rwpCR) in Cohort 1

The rwpCR is defined as the percentage of participants with resectable NSCLC who, according to available local surgical pathology reports as per routine clinical practice, demonstrate no residual viable tumor cells in the resected primary tumor and lymph nodes after neoadjuvant tislelizumab treatment.

Time frame
From date of first tislelizumab administration up to 30 months
2

Real-world Objective Response Rate (rwORR) in Cohorts 2, 3 and 4

The rwORR is defined as the percentage of participants with non-squamous NSCLC, squamous NSCLC, ES-SCLC, respectively, achieving a best overall response of complete or partial response (CR) or (PR) to tislelizumab, as assessed by the treating physician based on routine clinical documentation

Time frame
From date of first tislelizumab administration up to 30 months
3

Real-world Overall Survival (rwOS)

The rwOS is defined as the time from the date of first dose of study treatment to the date of death due to any cause.

Time frame
At selected landmark timepoints 12-month and 18-month
4

Real-world Pathological Complete Response (rwPCR) by Programmed Death Ligand 1 (PD-L1) Level in Cohort 1

The efficacy outcome will be summarized within PD-L1 subgroups using descriptive statistics

Time frame
From date of first tislelizumab administration up to 30 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BeOne Medicines

Lead sponsor

Source ClinicalTrials.gov
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