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NCT Number: NCT06536868

Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jincheng General Hospital, Jincheng, Shanxi, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • No prior antitumor treatment for extensive stage disease (if the patient has previously received chemotherapy and/or radiotherapy in the limited stage of SCLC, the treatment intent must have been curative, and there must be at least a 6-month treatment-free interval between the end of chemotherapy, radiotherapy, or chemoradiotherapy and the diagnosis of extensive stage SCLC);
  • Expected life span of ≥3 months;
  • Good function of vital organs;
  • The subject voluntarily joins this study, signs the informed consent form, has good compliance, and cooperates with follow-up.

Exclusion criteria

  • 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;
  • Female patients who are pregnant or breastfeeding, or women of childbearing potential with a positive baseline pregnancy test;
  • Prior use of antitumor treatment targeting the PD-(L)1 pathway.

Treatment and study plan

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

Primary outcomes

  1. Progression-free Survival (PFS)

    Time frame: Up to 2 years

    From the date of enrollment to the date of disease progression

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to 2 years

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

  2. Disease Control Rate (DCR)

    Time frame: Up to 2 years

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

  3. Overall Survival (OS)

    Time frame: Up to 2 years

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

  4. Adverse events

    Time frame: Up to 2 years

    Treatment-related adverse events according to CTCAE 5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Chen Zhang

CONTACT

[email protected]

+86 351 3365422

Gang Jin, Dr.

CONTACT

[email protected]

+86 351 3365422

Sponsors and collaborators

Lead sponsor

Second Hospital of Shanxi Medical University

Other

Registry information

Official study title

Tislelizumab Plus Chemotherapy and Concurrent Thoracic Radiotherapy as First-line Therapy for Extensive-stage Small-Cell Lung Cancer (ES-SCLC): an Multicenter, Single Arm Prospective Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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