Perioperative ImmunotherapyPhase 2NCT07109401
Perioperative Immunotherapy for Resectable Limited-Stage SCLC
A Phase 2 study testing Tislelizumab (BGB-A317) Plus Chemotherapy (Cisplatin/Carboplatin and Etoposide) in people with Perioperative Immunotherapy and Limited Stage Lung Small Cell Carcinoma, run by Fudan University at 1 site in China.
Trial summary
For limited-stage small cell lung cancer (SCLC), surgical treatment is recommended for patients with T1-2N0M0 (I-IIA) by guidelines. However, whether perioperative immunotherapy extends radical surgery to stage IIB-IIIB patients with improved survival remains elusive. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Perioperative Immunotherapy, Limited Stage Lung Small Cell Carcinoma, Resectable Small Cell Lung Cancer
- What is being tested?
- Tislelizumab (BGB-A317) Plus Chemotherapy (Cisplatin/Carboplatin and Etoposide)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent and understand and agree to comply with the study requirements and assessment schedule;
- Aged 18-75 years at the time of signing the informed consent form;
- Pathologically (histologically or cytologically) confirmed diagnosis of small cell lung cancer;
- Limited-stage disease (stage IIB-IIIB according to AJCC 8th edition) assessed by bronchoscopy, PET-CT, endobronchial ultrasound (EBUS), mediastinoscopy, or percutaneous biopsy, deemed resectable with curative intent (R0 resection) by the investigator.
- TNM staging includes T3-4 (N0 only) or N1-2 (any T) and M0, where T4 is limited to tumors >7 cm in diameter; Patients with tumors invading the diaphragm, mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, carina or having separate tumor nodules in different ipsilateral lobes are excluded. N2 is limited to single station and non-bulky.
- No prior radiotherapy, chemotherapy, immunotherapy, surgery or other systemic treatments;
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- ECOG PS score of 0-1;
- Expected survival must be >3 months;
- Adequate bone marrow reserve and organ function within 30 days prior to enrollment meeting criteria for receiving platinum-based doublet chemotherapy;
- No contraindications for immunotherapy.
Who cannot join
- Tumor histopathology indicates non-small cell lung cancer (NSCLC);
- Presence of clinically inactive or active brain metastases;
- Any history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis), current ILD, or suspicion of such diseases based on imaging during screening;
- Receiving systemic corticosteroid therapy within 14 days prior to the first dose of study drug;
- Previous radiotherapy, chemotherapy, immunotherapy, surgery, or other systemic treatments;
- Any active malignancy within 2 years prior to enrollment;
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- Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
- Uncontrolled or significant cardiovascular disease at the time of enrollment;
- Active or previously recorded autoimmune or inflammatory diseases before enrollment;
- History of active primary immunodeficiency disorders;
- Presence of active infections;
- Active bleeding disorders within ≤6 months prior to administration of the study drug, including gastrointestinal bleeding evidenced by hematemesis, severe hemoptysis, or melena;
- Non-healing wounds, active peptic ulcers, or fractures;
- Any condition that the investigator deems makes the patient unsuitable for participation in the study.
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
Fudan University Shanghai Cancer Center
Shanghai
Haoxuan Wu, +86-64175590 ext. 63189, haoxuanwu@hotmail.com
About this study
Official title: Perioperative Tislelizumab for Resectable Small Cell Lung Cancer in Stage IIB-IIIB: A Phase 2 Trial
For limited-stage small cell lung cancer (SCLC), surgical treatment is recommended for patients with T1-2N0M0 (I-IIA) by guidelines. However, whether perioperative immunotherapy extends radical surgery to stage IIB-IIIB patients with improved survival remains elusive.
This is a phase II, single-arm study to evaluate the efficacy and safety of neoadjuvant Tislelizumab + chemotherapy (Cisplatin/Carboplatin + Etoposide) followed by radical surgery and adjuvant Tislelizumab ± chemotherapy for patients with limited-stage SCLC.
- Conditions
- Perioperative Immunotherapy, Limited Stage Lung Small Cell Carcinoma, Resectable Small Cell Lung Cancer
- Being tested
- Tislelizumab (BGB-A317) Plus Chemotherapy (Cisplatin/Carboplatin and Etoposide)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab (BGB-A317) Plus Chemotherapy (Cisplatin/Carboplatin and Etoposide)Drug
Neoadjuvant therapy: Tislelizumab + Cisplatin or Carboplatin + Etoposide; Adjuvant therapy: Tislelizumab + Cisplatin or Carboplatin + Etoposide (the total cycle of perioperative chemotherapy is four), followed by Tislelizumab monotherapy for one year.
| Study group | Role | What they receive |
|---|---|---|
| Perioperative Tislelizumab combined with Etoposide and Platinum-based Chemotherapy | Experimental | Neoadjuvant therapy: Tislelizumab 200mg, i.v., q3w, 2-4 cycles; Cisplatin 75mg/m2, d1 or Carboplatin AUC5-6, d1 + Etoposide 100mg/m2, d1-3, q3w, 2-4 cycles.
Those resectable after neoadjuvant therapy will be treated with radical surgery.
Adjuvant therapy: Patients received radical surgery will be treated with Tislelizumab plus platinum-etoposide therapy (the total cycle of perioperative chemotherapy is four), followed by Tislelizumab monotherapy for one year. Receives: Drug: Tislelizumab (BGB-A317) Plus Chemotherapy (Cisplatin/Carboplatin and Etoposide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year Event-free Survival Rate (1-year EFS Rate)
The proportion of patients who have not experienced an EFS event within 1 year after the first administration of the study drug. EFS (Event-Free Survival) is defined as the time from the first dose of study treatment until the first occurrence of any of the following events: objectively documented disease progression and inability to undergo radical surgery, local recurrence, distant metastasis, or death from any cause (whichever occurs first). EFS is assessed by investigators based on RECIST v1.1 (Response evaluation criteria in solid tumors v1.1) criteria within the radical curative therapy analysis set.
Measured: Up to 12 months
Secondary outcomes (11)
Event-free Survival (EFS)
Event-Free Survival (EFS) - defined as the time from the first dose of study treatment until the first occurrence of any of the following events: objectively documented disease progression and inability to undergo radical surgery, local recurrence, distant metastasis, or death from any cause (whichever occurs first).
Measured: up to 60 months
Overall Survival (OS)
Overall Survival - defined as the time from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date.
Measured: up to 60 months
Objective Response Rate (ORR)
Objective Response Rate (ORR) - defined as the proportion of patients who achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as assessed by investigators according to RECIST v1.1 criteria.
Measured: Up to 12 months
Disease Control Rate (DCR)
Disease Control Rate (DCR) - defined as the proportion of patients who achieve a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), or Stable Disease (SD), as assessed by investigators according to RECIST v1.1 criteria.
Measured: Up to 12 months
Pathological Complete Response (pCR) Rate
Pathological Complete Response (pCR) Rate - defined as the proportion of patients who have no residual tumor in the resected primary tumor site and all resected lymph nodes after neoadjuvant therapy among those who underwent surgical resection.
Measured: Up to 12 months
Major Pathological Response (MPR) Rate
Major Pathological Response (MPR) Rate - defined as the proportion of patients who have ≤10% residual viable tumor cells in the resected primary tumor site and all resected lymph nodes after neoadjuvant therapy among those who underwent surgical resection.
Measured: Up to 12 months
Pathological Downstaging Rate
Pathological Downstaging Rate - defined as the proportion of patients who undergo surgical resection after neoadjuvant therapy and have a postoperative pathological stage that is lower than their baseline clinical tumor stage and/or lymph node involvement.
Measured: Up to 12 months
R0 Resection Rate
R0 Resection Rate - defined as the proportion of patients who achieve complete tumor resection (negative margins with no residual tumor cells) among those who underwent surgical resection after neoadjuvant therapy.
Measured: Up to 12 months
Clinical Downstaging Rate
Clinical Downstaging Rate - defined as the proportion of patients who have a reduction in tumor size and/or lymph node involvement in their clinical tumor stage after neoadjuvant therapy compared to their baseline clinical tumor stage before surgery.
Measured: Up to 12 months
Surgical Resection Rate
Surgical Resection Rate - defined as the proportion of patients who undergo surgical resection after neoadjuvant therapy.
Measured: Up to 12 months
Incidence of Treatment-emergent Adverse Event (TEAE) and Immune-related Adverse Event (IrAE)
The incidence of TEAE and IrAE will be assessed by monitoring adverse events (AEs) and serious adverse events (SAEs) as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, and by incorporating relevant physical examinations, electrocardiograms (ECGs), and laboratory tests as needed.
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Mar 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative ImmunotherapyStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiquan Chen, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109401
- Sponsor's protocol ID
- ECTOP-1033
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The clinical data including patient characteristics, CT images and pathology images.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Tislelizumab for Resectable Small Cell Lung Cancer in Stage IIB-IIIB: A Phase 2 Trial
- ClinicalTrials.gov ID
- NCT07109401
- Acronym / sponsor ID
- ECTOP-1033
- Conditions
- Perioperative Immunotherapy, Limited Stage Lung Small Cell Carcinoma, Resectable Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Aug 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.
For limited-stage small cell lung cancer (SCLC), surgical treatment is recommended for patients with T1-2N0M0 (I-IIA) by guidelines. However, whether perioperative immunotherapy extends radical surgery to stage IIB-IIIB patients with improved survival remains elusive.
This is a phase II, single-arm study to evaluate the efficacy and safety of neoadjuvant Tislelizumab + chemotherapy (Cisplatin/Carboplatin + Etoposide) followed by radical surgery and adjuvant Tislelizumab ± chemotherapy for patients with limited-stage SCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perioperative Tislelizumab combined with Etoposide and Platinum-based Chemotherapy | Experimental | Drug: Tislelizumab (BGB-A317) Plus Chemotherapy (Cisplatin/Carboplatin and Etoposide)Neoadjuvant therapy: Tislelizumab 200mg, i.v., q3w, 2-4 cycles; Cisplatin 75mg/m2, d1 or Carboplatin AUC5-6, d1 + Etoposide 100mg/m2, d1-3, q3w, 2-4 cycles. Those resectable after neoadjuvant therapy will be treated with radical surgery. Adjuvant therapy: Patients received radical surgery will be treated with Tislelizumab plus platinum-etoposide therapy (the total cycle of perioperative chemotherapy is four), followed by Tislelizumab monotherapy for one year. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able to provide written informed consent and understand and agree to comply with the study requirements and assessment schedule;
- Aged 18-75 years at the time of signing the informed consent form;
- Pathologically (histologically or cytologically) confirmed diagnosis of small cell lung cancer;
- Limited-stage disease (stage IIB-IIIB according to AJCC 8th edition) assessed by bronchoscopy, PET-CT, endobronchial ultrasound (EBUS), mediastinoscopy, or percutaneous biopsy, deemed resectable with curative intent (R0 resection) by the investigator.
- TNM staging includes T3-4 (N0 only) or N1-2 (any T) and M0, where T4 is limited to tumors >7 cm in diameter; Patients with tumors invading the diaphragm, mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, carina or having separate tumor nodules in different ipsilateral lobes are excluded. N2 is limited to single station and non-bulky.
Key exclusion criteria (14 listed)
- Tumor histopathology indicates non-small cell lung cancer (NSCLC);
- Presence of clinically inactive or active brain metastases;
- Any history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis), current ILD, or suspicion of such diseases based on imaging during screening;
- Receiving systemic corticosteroid therapy within 14 days prior to the first dose of study drug;
- Previous radiotherapy, chemotherapy, immunotherapy, surgery, or other systemic treatments;
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 (BGB-A317) Plus Chemotherapy (Cisplatin/Carboplatin and Etoposide)Neoadjuvant therapy: Tislelizumab + Cisplatin or Carboplatin + Etoposide; Adjuvant therapy: Tislelizumab + Cisplatin or Carboplatin + Etoposide (the total cycle of perioperative chemotherapy is four), followed by Tislelizumab monotherapy for one year. | Drug | Perioperative Tislelizumab combined with Etoposide and Platinum-based Chemotherapy |
Primary outcome
One-year Event-free Survival Rate (1-year EFS Rate)
Time frame: Up to 12 months
The proportion of patients who have not experienced an EFS event within 1 year after the first administration of the study drug. EFS (Event-Free Survival) is defined as the time from the first dose of study treatment until the first occurrence of any of the following events: objectively documented disease progression and inability to undergo radical surgery, local recurrence, distant metastasis, or death from any cause (whichever occurs first). EFS is assessed by investigators based on RECIST v1.1 (Response evaluation criteria in solid tumors v1.1) criteria within the radical curative therapy analysis set.
11 secondary outcomes
Event-free Survival (EFS)
Time frame: up to 60 months
Overall Survival (OS)
Time frame: up to 60 months
Objective Response Rate (ORR)
Time frame: Up to 12 months
Disease Control Rate (DCR)
Time frame: Up to 12 months
Pathological Complete Response (pCR) Rate
Time frame: Up to 12 months
Major Pathological Response (MPR) Rate
Time frame: Up to 12 months
Pathological Downstaging Rate
Time frame: Up to 12 months
R0 Resection Rate
Time frame: Up to 12 months
Clinical Downstaging Rate
Time frame: Up to 12 months
Surgical Resection Rate
Time frame: Up to 12 months
Incidence of Treatment-emergent Adverse Event (TEAE) and Immune-related Adverse Event (IrAE)
Time frame: Up to 60 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 7 Aug 2025.
- Individual participant dataSharing planned: Yes. The clinical data including patient characteristics, CT images and pathology images.
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 (BGB-A317) Plus Chemotherapy (Cisplatin/Carboplatin and Etoposide) in people with Perioperative Immunotherapy and Limited Stage Lung Small Cell Carcinoma, run by Fudan University 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 10 inclusion and 14 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 7 Aug 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 Haiquan Chen, MD, Ph.D. (+86-18121299888, hqchen1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year Event-free Survival Rate (1-year EFS Rate) (time frame: Up to 12 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 7 Aug 2025; AzTrials last refreshed its copy on 31 Oct 2026.