Limited-stage Small-cell Lung CancerPhase 2NeoSCLC-001NCT06375109
PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage SCLC
A Phase 2 study testing Tislelizumab, Carboplatin injection and Cisplatin injection in people with Limited-stage Small-cell Lung Cancer, run by Beijing Chest Hospital, Capital Medical University.
Trial summary
This is an open-label, non-randomized, controlled, single-center, phase II study to compare the efficacy and safety of neoadjuvant PD-L1/PD-1 inhibitor + chemotherapy (carboplatin/cisplatin + etoposide) with chemotherapy (carboplatin/cisplatin + etoposide) alone followed by radical surgery and adjuvant treatment as… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Limited-stage Small-cell Lung Cancer
- What is being tested?
- Tislelizumab, Carboplatin injection and Cisplatin injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 16 Apr 2024to 15 Apr 2029
- 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
- Patients voluntarily participated in this study, signed an informed consent form, and demonstrated good compliance.
- They were histologically or cytologically confirmed with limited-stage small-cell lung cancer (TNM stage; T1-3N0-2M0).
- The age range was 18 to 75 years, with no gender restriction.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0-2.
- Life expectancy was estimated to be at least 3 months.
- No previous anti-tumor treatment specifically for SCLC was administered.
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- According to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, there must be at least one measurable lesion.
- Patients' organ functions must be adequately sufficient, with the following requirements to be met before the first study treatment:
- Hematological parameters: ANC ≥1.5×10^9/L, platelets ≥100×10^9/L, hemoglobin ≥90g/L.
- Renal function: serum creatinine ≤1.5 times the upper limit, or creatinine clearance ≥50 mL/min.
- Liver function: ALT/AST ≤2.5 times the upper limit, total serum bilirubin ≤2 times the upper limit.
- Coagulation: INR should be ≤ 1.5 times the upper limit.
- Patients of childbearing potential must agree to use contraception.
- Patients must be able to tolerate chemotherapy, immunotherapy, and surgery.
Who cannot join
- Patients who have received anti-tumor treatment for SCLC (including but not limited to chemotherapy and radiation therapy at the site of the lesion).
- Patients who have previously used immune checkpoint inhibitors such as PD-1/PD-L1 inhibitors for treatment.
- Patients with a history of interstitial lung disease, non-infectious pneumonia, or uncontrollable systemic diseases, including pulmonary fibrosis and acute lung disease.
- Patients requiring systemic anti-bacterial, anti-fungal, or anti-viral treatment for severe chronic or active infections, including tuberculosis.
- Patients known to have HIV.
- Patients with active hepatitis B or hepatitis C.
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- Patients with active autoimmune diseases or a history of autoimmune diseases that may recur.
- Patients with diseases requiring systemic corticosteroid treatment or other immunosuppressive therapy.
- Patients deemed by the investigator to have concomitant diseases that pose a serious risk to patient safety or could affect the patient's ability to complete the study.
- Patients who have undergone major surgery within 4 weeks prior to treatment initiation, or those with significant trauma or fractures, or those with unhealed wounds at the time of treatment.
- Patients with severe cardiac diseases, such as NYHA class III or higher congestive heart failure, CCS class III or higher angina, a history of myocardial infarction in the past 6 months, or arrhythmias requiring medication.
- Patients with comorbidities that make them unsuitable for surgery.
- Patients who have had an allergic reaction to the study drug or excipients in the medication.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage Small Cell Lung Cancer: an Open-label, Non-randomized Controlled, Phase II, Single-center Study
This is an open-label, non-randomized, controlled, single-center, phase II study to compare the efficacy and safety of neoadjuvant PD-L1/PD-1 inhibitor + chemotherapy (carboplatin/cisplatin + etoposide) with chemotherapy (carboplatin/cisplatin + etoposide) alone followed by radical surgery and adjuvant treatment as perioperative therapy in patients with limited-stage SCLC.
- Conditions
- Limited-stage Small-cell Lung Cancer
- Being tested
- Tislelizumab, Carboplatin injection, Cisplatin injection, Etoposide injection
- 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
administered via Intravenous (IV) injection
Carboplatin injectionDrug
administered via IV injection
Cisplatin injectionDrug
administered via IV injection
Etoposide injectionDrug
administered via IV injection
| Study group | Role | What they receive |
|---|---|---|
| neoCIT | Experimental | Neoadjuvant chemotherapy + Tislelizumab(2-3 cycles), Adjuvant chemotherapy + Tislelizumab (1-2 cycles), Maintenance Tislelizumab Receives: Drug: Tislelizumab; Drug: Carboplatin injection; Drug: Cisplatin injection; Drug: Etoposide injection |
| neoCT | Active comparator | Neoadjuvant chemotherapy (2-3 cycles), Adjuvant chemotherapy (1-2 cycles) Receives: Drug: Carboplatin injection; Drug: Cisplatin injection; Drug: Etoposide injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pCR) Rate
pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
Measured: Up to 3 months following completion of neoadjuvant treatment
Secondary outcomes (5)
Major Pathologic Response (MPR) Rate
MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes in neoadjuvant therapy.
Measured: Up to 3 months following completion of neoadjuvant treatment
Event-Free Survival (EFS)
EFS is defined as the time from enrollment until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause.
Measured: up to 5 years
Overall Survival (OS)
OS is defined as the time from enrollment until death from any cause.
Measured: up to 5 years
Objective response rate (ORR)
The proportion of patients who have had a complete response or partial response (according to RECIST1.1) in all patients who have completed the neoadjuvant therapy.
Only patients with measurable lesions at baseline will be analyzed.
Measured: Up to 1 months following completion of neoadjuvant treatment
Safety: frequency of severe adverse events
The frequency of severe adverse events from the participants enrolling to 90 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start16 Apr 2024 (estimated)
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limited-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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chest Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Shi, MD, Beijing Chest Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375109
- Sponsor's protocol ID
- BJXK-2023-KY-53
- Other IDs
- NeoSCLC-001
- Acronym
- NeoSCLC-001
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The researchers will consider whether IPD is available to other researchers only after the paper is published
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage Small Cell Lung Cancer: an Open-label, Non-randomized Controlled, Phase II, Single-center Study
- ClinicalTrials.gov ID
- NCT06375109
- Acronym / sponsor ID
- NeoSCLC-001 / BJXK-2023-KY-53
- Conditions
- Limited-stage Small-cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Chest Hospital, Capital Medical UniversityUniversity, hospital or other
- Study start
- 16 Apr 2024 (estimated)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Apr 2029 (estimated)
- First posted
- 19 Apr 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 is an open-label, non-randomized, controlled, single-center, phase II study to compare the efficacy and safety of neoadjuvant PD-L1/PD-1 inhibitor + chemotherapy (carboplatin/cisplatin + etoposide) with chemotherapy (carboplatin/cisplatin + etoposide) alone followed by radical surgery and adjuvant treatment as perioperative therapy in patients with limited-stage SCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neoCIT | Experimental | Drug: Tislelizumab, Drug: Carboplatin injection, Drug: Cisplatin injection, Drug: Etoposide injectionNeoadjuvant chemotherapy + Tislelizumab(2-3 cycles), Adjuvant chemotherapy + Tislelizumab (1-2 cycles), Maintenance Tislelizumab |
| neoCT | Active comparator | Drug: Carboplatin injection, Drug: Cisplatin injection, Drug: Etoposide injectionNeoadjuvant chemotherapy (2-3 cycles), Adjuvant chemotherapy (1-2 cycles) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients voluntarily participated in this study, signed an informed consent form, and demonstrated good compliance.
- They were histologically or cytologically confirmed with limited-stage small-cell lung cancer (TNM stage; T1-3N0-2M0).
- The age range was 18 to 75 years, with no gender restriction.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0-2.
- Life expectancy was estimated to be at least 3 months.
Key exclusion criteria (13 listed)
- Patients who have received anti-tumor treatment for SCLC (including but not limited to chemotherapy and radiation therapy at the site of the lesion).
- Patients who have previously used immune checkpoint inhibitors such as PD-1/PD-L1 inhibitors for treatment.
- Patients with a history of interstitial lung disease, non-infectious pneumonia, or uncontrollable systemic diseases, including pulmonary fibrosis and acute lung disease.
- Patients requiring systemic anti-bacterial, anti-fungal, or anti-viral treatment for severe chronic or active infections, including tuberculosis.
- Patients known to have HIV.
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 |
|---|---|---|
| Tislelizumabadministered via Intravenous (IV) injection | Drug | neoCIT |
| Carboplatin injectionadministered via IV injection | Drug | neoCIT, neoCT |
| Cisplatin injectionadministered via IV injection | Drug | neoCIT, neoCT |
| Etoposide injectionadministered via IV injection | Drug | neoCIT, neoCT |
Primary outcome
Pathologic Complete Response (pCR) Rate
Time frame: Up to 3 months following completion of neoadjuvant treatment
pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
5 secondary outcomes
Major Pathologic Response (MPR) Rate
Time frame: Up to 3 months following completion of neoadjuvant treatment
Event-Free Survival (EFS)
Time frame: up to 5 years
Overall Survival (OS)
Time frame: up to 5 years
Objective response rate (ORR)
Time frame: Up to 1 months following completion of neoadjuvant treatment
Safety: frequency of severe adverse events
Time frame: up to 6 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 19 Apr 2024.
- Individual participant dataSharing planned: Undecided. The researchers will consider whether IPD is available to other researchers only after the paper is published
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab, Carboplatin injection and Cisplatin injection in people with Limited-stage Small-cell Lung Cancer, run by Beijing Chest Hospital, Capital Medical University.
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 14 inclusion and 13 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: opening soon, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Liang Shi, MD (+8613488787767, shiliang@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (pCR) Rate (time frame: Up to 3 months following completion of neoadjuvant treatment). 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 19 Apr 2024.