Extensive-stage Small Cell Lung Cancer (ES-SCLC)Phase 2NCT06838208
Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in First-line Treatment of ES-SCLC
A Phase 2 study testing Tislelizumab, Carboplatin /Cisplatin, Etoposide in people with Extensive-stage Small Cell Lung Cancer (ES-SCLC), run by Anhui Provincial Cancer Hospital at 1 site in China.
Trial summary
To explore the efficacy and safety of Tislelizumab combined with chemotherapy and relayed radiotherapy in the first-line treatment of extensive small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small Cell Lung Cancer (ES-SCLC)
- What is being tested?
- Tislelizumab, Carboplatin /Cisplatin, Etoposide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2025to 1 Apr 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years old, male or female, signed Informed Consent Form (ICF);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Histologically or cytologically confirmed ES-SCLC;
- No prior systemic treatment for ES-SCLC;
- At least one measurable (RECIST 1.1) chest lesion capable of 15Gy/5f irradiation;
- Adequate hematologic and end organ function;
Who cannot join
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis;
- Prior therapy with an antibody or drug against immune checkpoint pathways, including but not limited to, anti program death receptor-1 (anti-PD-1), anti-PD-L1, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA-4) antibody;
- Was administered a live vaccine ≤ 4 weeks before treatment;
- Active autoimmune diseases or history of autoimmune diseases that may relapse;
- Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before treatment;
- With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases;
- Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks prior to treatment, including but not limited to tuberculosis infection;
- Received therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to starting treatment;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Anhui Cancer Hospital
Hefei, Anhui, 230031
Shuanghu Yuan, PhD, 0551-62894008, yuanshuanghu@sina.com
About this study
Official title: Efficacy and Safety of Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in the First-line Treatment of Extensive Small Cell Lung Cancer: a Prospective, Multicenter, Phase II Clinical Study
To explore the efficacy and safety of Tislelizumab combined with chemotherapy and relayed radiotherapy in the first-line treatment of extensive small cell lung cancer
- Being tested
- Tislelizumab, Carboplatin /Cisplatin, Etoposide
- 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.
Tislelizumab, Carboplatin /Cisplatin, EtoposideDrug
Also called radiotherapy
Induction therapy stage LDRT: lung lesions, 15Gy/5f; Maintenance therapy phase SBRT: The main residual lesions evaluated by the investigators, 30Gy/5f；
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab plus chemo and radiotherapy | Experimental | Experimental treatment
1. Drug: Tislelizumab, Carboplatin /Cisplatin, Etoposide
• Tislelizumab (200 mg IV Q3W) in combination with chemotherapy consisting of etoposide (100 mg/m² IV Days 1-3 of each 21-day cycle) and platinum (cisplatin 75 mg/m² IV Q3W or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 IV Q3W) for 4 cycles. Then maintenance consists of Tislelizumab Q3W and will continue until disease progression, loss of clinical benefit, unacceptable toxicity, or withdrawal of informed consent，up to 2 years.
2. Radiotherapy:
* Induction therapy stage LDRT: lung lesions, 15Gy/5f;
* Maintenance therapy phase SBRT: The main residual lesions evaluated by the investigators, 30Gy/5f；
Control group: This study refers to the Phase III RATIONALE-312 study, the reported median PFS was 4.7 months in patients treated with Tislelizumab combined with chemotherapy. This regimen has been recommened as 1L treatment for ES-SCLC in the CSCO guidelines. Receives: Drug: Tislelizumab, Carboplatin /Cisplatin, Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide and radiotherapy in the intent to treat (ITT) Analysis Set as measured by investigator assessed progression free survival (PFS) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Measured: Baseline until PD or death, whichever occurs first or up to approximately 23 months
Secondary outcomes (6)
Objective Response Rate (ORR)
To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide +radiotherapy in the ITT Analysis Set as measured by investigator assessed overall response rate (ORR), according to RECIST v1.1
Measured: Baseline until partial response (PR) or complete response (CR), whichever occurs or up to approximately 23 months
Duration Of Response (DOR)
To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide+ radiotherapy in the ITT Analysis Set as measured by investigator assessed duration of response (DOR) according to RECIST v1.1
Measured: Baseline until partial response (PR) or complete response (CR), whichever occurs first, or up to approximately 23 months
Disease Control Rate (DCR)
To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide + radiotherapy in the ITT Analysis Set as measured by investigator assessed disease control rate (DCR) according to RECIST v1.1
Measured: up to approximately 23 months
6-moth/1-year Progression Free Survival (PFS) Rate
The PFS rate will be defined as the proportion of participants free from PFS events at 6 month and 1st year after the first dose.
Measured: up to approximately 23 months
1-year Overall Survival (OS) rate
The OS rate will be defined as the proportion of participants free from OS events at 1st year after the first dose.
Measured: up to approximately 23 months
Number Of Participants Experiencing Treatment-Emergent Adverse Events
Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to National Cancer Institute Common Terminology Criteria for Adverse Events
Measured: up to approximately 23 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start25 Feb 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2028 (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 Cancer (ES-SCLC)Studies 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuanghu Yuan, Anhui Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838208
- Sponsor's protocol ID
- PRAD1
- Other IDs
- CRTOG2501
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in the First-line Treatment of Extensive Small Cell Lung Cancer: a Prospective, Multicenter, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06838208
- Acronym / sponsor ID
- PRAD1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Anhui Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 20 Feb 2025 (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.
To explore the efficacy and safety of Tislelizumab combined with chemotherapy and relayed radiotherapy in the first-line treatment of extensive 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 |
|---|---|---|
| Tislelizumab plus chemo and radiotherapy | Experimental | Drug: Tislelizumab, Carboplatin /Cisplatin, EtoposideExperimental treatment 1. Drug: Tislelizumab, Carboplatin /Cisplatin, Etoposide • Tislelizumab (200 mg IV Q3W) in combination with chemotherapy consisting of etoposide (100 mg/m² IV Days 1-3 of each 21-day cycle) and platinum (cisplatin 75 mg/m² IV Q3W or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 IV Q3W) for 4 cycles. Then maintenance consists of Tislelizumab Q3W and will continue until disease progression, loss of clinical benefit, unacceptable toxicity, or withdrawal of informed consent，up to 2 years. 2. Radiotherapy: * Induction therapy stage LDRT: lung lesions, 15Gy/5f; * Maintenance therapy phase SBRT: The main residual lesions evaluated by the investigators, 30Gy/5f； Control group: This study refers to the Phase III RATIONALE-312 study, the reported median PFS was 4.7 months in patients treated with Tislelizumab combined with chemotherapy. This regimen has been recommened as 1L treatment for ES-SCLC in the CSCO guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age≥18 years old, male or female, signed Informed Consent Form (ICF);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Histologically or cytologically confirmed ES-SCLC;
- No prior systemic treatment for ES-SCLC;
- At least one measurable (RECIST 1.1) chest lesion capable of 15Gy/5f irradiation;
Key exclusion criteria (8 listed)
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis;
- Prior therapy with an antibody or drug against immune checkpoint pathways, including but not limited to, anti program death receptor-1 (anti-PD-1), anti-PD-L1, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA-4) antibody;
- Was administered a live vaccine ≤ 4 weeks before treatment;
- Active autoimmune diseases or history of autoimmune diseases that may relapse;
- Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before treatment;
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 |
|---|---|---|
| Tislelizumab, Carboplatin /Cisplatin, EtoposideAlso: radiotherapyInduction therapy stage LDRT: lung lesions, 15Gy/5f; Maintenance therapy phase SBRT: The main residual lesions evaluated by the investigators, 30Gy/5f； | Drug | Tislelizumab plus chemo and radiotherapy |
Primary outcome
Progression Free Survival (PFS)
Time frame: Baseline until PD or death, whichever occurs first or up to approximately 23 months
To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide and radiotherapy in the intent to treat (ITT) Analysis Set as measured by investigator assessed progression free survival (PFS) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: Baseline until partial response (PR) or complete response (CR), whichever occurs or up to approximately 23 months
Duration Of Response (DOR)
Time frame: Baseline until partial response (PR) or complete response (CR), whichever occurs first, or up to approximately 23 months
Disease Control Rate (DCR)
Time frame: up to approximately 23 months
6-moth/1-year Progression Free Survival (PFS) Rate
Time frame: up to approximately 23 months
1-year Overall Survival (OS) rate
Time frame: up to approximately 23 months
Number Of Participants Experiencing Treatment-Emergent Adverse Events
Time frame: up to approximately 23 months
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 Sep 2025.
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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.
1 site 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, Carboplatin /Cisplatin, Etoposide in people with Extensive-stage Small Cell Lung Cancer (ES-SCLC), run by Anhui Provincial Cancer Hospital at 1 site 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 6 inclusion and 8 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 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Shuanghu Yuan, PhD (0551-62894008, yuanshuanghu@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: Baseline until PD or death, whichever occurs first or up to approximately 23 months). 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 Sep 2025.