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Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC

ConditionExtensive-stage Small-cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSecond Hospital of Shanxi Medical University

About this trial

This study is a single arm, open, multicenter phase II study. The main purpose of this study was to evaluate preliminary efficacy and safety of Tislelizumab combined with thoracic radiotherapy as first line therapy for Extensive stage small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged between 18 to 80 years old (inclusive of 18th and 80th birthdays), male or female, at the time of signing the informed consent form;

Confirmed small cell lung cancer of extensive stage by histology or cytology;

At least one measurable lesion by imaging studies (according to RECIST 1.1) with a long diameter of ≥10 mm as examined by spiral CT or MRI;

Within 3 days prior to treatment, an ECOG score of 0 to 1;

Disqualifiers

Concurrent severe respiratory diseases: such as pulmonary fibrosis;

Presence of psychiatric disorders, hematologic diseases, autoimmune diseases, and severe primary diseases of the heart, brain, liver, or kidneys;

Uncontrolled active infections;

Known or suspected allergies to the study medication and its excipients;

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab

    Drug

    Tislelizumab infusion will be administered for 2 years (200mg, day1, Q3W).

  • Etoposide

    Drug

    Etoposide intravenous infusion will be administered during the induction phase (100mg/㎡, day1-3 Q3W for 4 cycles).

  • Carboplatin or Cisplatin

    Drug

    Carboplatin or Cisplatin intravenous infusion will be administered during the induction phase (Carboplatin AUC5, Q3W for 4 cycles; Cisplatin 75mg/㎡, Q3W for 4 cycles).

  • Thoracic radiotherapy

    Radiation

    IMRT 30-45Gy/10-15f

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: ICI+EC/EP+TRTExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Progression-free Survival (PFS)

From the date of enrollment to the date of disease progression

Time frame
Up to 2 years

Secondary outcomes

1

Objective Response Rate (ORR)

ORR as assessed by the Investigator according to RECIST v1.1

Time frame
Up to 2 years
2

Disease Control Rate (DCR)

DCR as assessed by the Investigator according to RECIST v1.1

Time frame
Up to 2 years
3

Overall Survival （OS）

From the date of enrollment until death by any cause or last follow-up

Time frame
Up to 2 years
4

Adverse events

Treatment-related adverse events according to CTCAE 5.0.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

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

Second Hospital of Shanxi Medical University

Lead sponsor

Source ClinicalTrials.gov
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