Extensive-stage Small-cell Lung CancerPhase 2NCT06536868
Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC
A Phase 2 study testing Tislelizumab, Etoposide and Carboplatin or Cisplatin in people with Extensive-stage Small-cell Lung Cancer, run by Second Hospital of Shanxi Medical University at 6 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Extensive-stage Small-cell Lung Cancer
- What is being tested?
- Tislelizumab, Etoposide and Carboplatin or Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesChina
- Study dates
- 1 Aug 2024to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Jincheng General Hospital
Jincheng, Shanxi, 048000
Xueqin Li, Dr., +86 356 3661360
- Recruiting
Jinzhong third people's hospital
Jinzhong, Shanxi, 032000
Qian Wu, Dr., +86 354 3532157
- Recruiting
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030000
Gang Jin, Dr., +86 351 3365422
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030000
Huijing Feng, Dr., +86 351 8368114
- Recruiting
Shanxi Hospital of Traditional Chinese Medicine
Taiyuan, Shanxi, 030000
Jinyang Bai, Dr., +86 351 303009
- Recruiting
TISCO General Hospital
Taiyuan, Shanxi, 030000
Weihua Jia, Dr., +86 351 3012448
About this study
Official 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
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.
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Being tested
- Tislelizumab, Etoposide, Carboplatin or Cisplatin, Thoracic radiotherapy
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Tislelizumab infusion will be administered for 2 years (200mg, day1, Q3W).
EtoposideDrug
Etoposide intravenous infusion will be administered during the induction phase (100mg/㎡, day1-3 Q3W for 4 cycles).
Carboplatin or CisplatinDrug
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 radiotherapyRadiation
IMRT 30-45Gy/10-15f
| Study group | Role | What they receive |
|---|---|---|
| ICI+EC/EP+TRT | Experimental | Drug: Tislelizumab Drug: Carboplatin Drug: Etoposide Radiation: Radiation therapy Drug: Cisplatin Receives: Drug: Tislelizumab; Drug: Etoposide; Drug: Carboplatin or Cisplatin; Radiation: Thoracic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
From the date of enrollment to the date of disease progression
Measured: Up to 2 years
Secondary outcomes (4)
Objective Response Rate (ORR)
ORR as assessed by the Investigator according to RECIST v1.1
Measured: Up to 2 years
Disease Control Rate (DCR)
DCR as assessed by the Investigator according to RECIST v1.1
Measured: Up to 2 years
Overall Survival （OS）
From the date of enrollment until death by any cause or last follow-up
Measured: Up to 2 years
Adverse events
Treatment-related adverse events according to CTCAE 5.0.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-stage Small-cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Jin, Second Hospital of Shanxi Medical University
- Investigators
- Gang Jin, Dr., Principal investigator, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536868
- Sponsor's protocol ID
- [2024] YX No. 274
- Status last verified
- Apr 2026
- First submitted
- 31 Jul 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06536868
- Acronym / sponsor ID
- [2024] YX No. 274
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICI+EC/EP+TRT | Experimental | Drug: Tislelizumab, Drug: Etoposide, Drug: Carboplatin or Cisplatin, Radiation: Thoracic radiotherapyDrug: Tislelizumab Drug: Carboplatin Drug: Etoposide Radiation: Radiation therapy Drug: Cisplatin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TislelizumabTislelizumab infusion will be administered for 2 years (200mg, day1, Q3W). | Drug | ICI+EC/EP+TRT |
| EtoposideEtoposide intravenous infusion will be administered during the induction phase (100mg/㎡, day1-3 Q3W for 4 cycles). | Drug | ICI+EC/EP+TRT |
| Carboplatin or CisplatinCarboplatin or Cisplatin intravenous infusion will be administered during the induction phase (Carboplatin AUC5, Q3W for 4 cycles; Cisplatin 75mg/㎡, Q3W for 4 cycles). | Drug | ICI+EC/EP+TRT |
| Thoracic radiotherapyIMRT 30-45Gy/10-15f | Radiation | ICI+EC/EP+TRT |
Primary outcome
Progression-free Survival (PFS)
Time frame: Up to 2 years
From the date of enrollment to the date of disease progression
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 2 years
Disease Control Rate (DCR)
Time frame: Up to 2 years
Overall Survival （OS）
Time frame: Up to 2 years
Adverse events
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gang Jin, Dr. principal investigator
Second Hospital of Shanxi Medical University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab, Etoposide and Carboplatin or Cisplatin in people with Extensive-stage Small-cell Lung Cancer, run by Second Hospital of Shanxi Medical University at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gang Jin, Dr. (+86 351 3365422, jingang2018@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.