Unresectable Lung Non-Small Cell CarcinomaPhase 2NCT05837052
A Phase II Trial to Evaluate the Efficiency and Safety of Serplulimab Plus Chemotherapy as Conversion Therapy in NSCLC
A Phase 2 study testing serplulimab plus chemotherapy as conversion treatment in people with Unresectable Lung Non-Small Cell Carcinoma, run by Zhejiang University at 1 site in China.
Trial summary
This is a phase II, single-arm study to evaluate the efficacy and safety of Serplulimab plus chemotherapy as conversion treatment in patients with stage IIIB-IVA oligometastatic non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unresectable Lung Non-Small Cell Carcinoma
- What is being tested?
- serplulimab plus chemotherapy as conversion treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2023to 30 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients should voluntarily join this study and sign the informed consent form
- NSCLC patients diagnosed by cytology or histology and not previously receiving anti-tumor treatments (including systemic treatments, local treatments .etc)
- Patients with IIIB - IVA oligometastatic NSCLC : (a) IIIB - IIIC stage (T1-4N2-3): patients are not suitable or refuse to receive upfront surgical resection or radiotherapy; (b) oligometastatic stage IV (T1-3N0-2): radical resection/radiotherapy is feasible for metastatic lesions (the number of metastases being up to 3, and the maximum diameter of metastases being up to 2cm)
- After evaluation by MDT, upfront surgical resection is not the preferred treatment, but after induction systemic treatments, radical resection of the primary tumor is feasible, and radical resection/radiotherapy is feasible for extrathoracic metastases (if any)
- Age from 18 to 75 years old, both male and female
- ECOG score 0-1
Show all 11Show fewer
- According to the RECIST v1.1 , patients should have at least one measurable lesion
- For suspicious mediastinal lymph nodes (including pathological enlargement or PET-CT indicating malignancy, etc.), further sampling is required for pathological diagnosis by EUBS, thoracoscopy, or mediastinoscopy
- According clinical evaluation, the lung function of patients (such as FVC, FEV1, TLC, FRC, DLco, etc.) should be sufficient for pneumonectomy
- The function of important organs should meet the following requirements: absolute count of neutrophils ≥ 1.5 × 109/L； Platelets ≥ 100 × 109/L； Hemoglobin ≥ 90g/L; Serum albumin ≥ 35g/L; Thyroid hormone (TSH) ≤ 1 × ULN； Serum bilirubin ≤ 1.5 × ULN； ALT and AST ≤ 3 × ULN； International standardized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 × ULN； Serum creatinine ≤ 1.5 × ULN
- Female patients at childbearing age are required to use contraceptive measures; for male patients whose partners are women at childbearing age, effective methods of contraception should be used during the trial period
Who cannot join
- Patients who meet any of the following conditions will not be enrolled in this study:
- NSCLC patients have sensitive EGFR mutation, EML4-ALK fusion or other forms of ALK gene changes
- Patients have previously received immune checkpoint inhibitors such as PD-1/ PD-L1/CTLA4 antibody
- Patients with other primary malignancies within the past 3 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ)
- Patients with active hepatitis B/C
- Patients with any active autoimmune diseases or a history of autoimmune diseases
Show all 13Show fewer
- Patients who are using immunosuppressive agents or require systemic hormone therapy
- Patients with hypertension but without good control even through antihypertensive medication treatment ; patients with clinical symptoms or diseases related to unsatisfying cardiac function
- Patients with abnormal coagulation function (INR>2.0, PT>16s)
- Arterial/venous thrombotic events occurred before screening within 6 months
- Patients with active infection
- Patients with congenital or acquired immune dysfunction (such as HIV infection)
- According to the judgment of the researchers, patients have other factors that may affect the results of the research or cause the research to be terminated
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
Zhejiang University
Hangzhou, Zhejiang, 310058
Lulu Liu, weijiafang@zju.edu.cn
About this study
Official title: A Phase II Trial to Evaluate the Efficiency and Safety of Serplulimab Plus Chemotherapy as Conversion Treatment for Patients With Stage IIIB-IVA Oligometastatic Non-small Cell Lung Cancer
This is a phase II, single-arm study to evaluate the efficacy and safety of Serplulimab plus chemotherapy as conversion treatment in patients with stage IIIB-IVA oligometastatic non-small cell lung cancer.
Read the detailed description
This single-arm, open-label, prospective phase II clinical trial was designed to evaluate the efficacy and safety of Serplulimab plus chemotherapy as conversion treatment in patients with stage IIIB-IVA oligometastatic non-small cell lung cancer.
The primary endpoints were the rate of NSCLC converting to resectable tumors and the 1-year progression-free survival (PFS) rate.The secondary endpoints included the rates of R0 resection, major pathological response (MPR) and pathological complete response (pCR), overall survival (OS) and PFS. Multi-omics analysis will be performed to identify potential biomarkers for treatment response.
- Being tested
- serplulimab plus chemotherapy as conversion treatment
- Keywords
- Unresectable NSCLC, Serplulimab, Conversion treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serplulimab plus chemotherapy as conversion treatmentProcedure or surgery
Patients with unresectable NSCLC will receive serplulimab plus chemotherapy as conversion treatment, and then curative pneumonectomy will be provided for patients who are suitable for primary tumor resection. Locoregional ablative treatments will be performed for metastatic lesions.
| Study group | Role | What they receive |
|---|---|---|
| Serplulimab plus chemotherapy | Experimental | Patients with unresectable NSCLC will receive 3-4 cycles of serplulimab plus chemotherapy as the conversion treatment (serplulimab 300mg d1 q3w; carboplatin (AUC 5) on day 1, and pemetrexed (500 mg/m2 for adenocar- cinoma) or nab-paclitaxel (260 mg/m2 for squamous carcinoma) d1 q3w), and then curative pneumonectomy will be provided for patients who are suitable for primary tumor resection. Locoregional ablative treatments will be performed for metastatic lesions. Maintenance treatment with PD-1 antibody q3w will continue up to 12 months or disease progression after surgery. Receives: Procedure: serplulimab plus chemotherapy as conversion treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of NSCLC converting to resectable tumors
the proportion of unresectable NSCLC patients who are converted to being suitable for radical pneumonectomy after 3-4 cycles serplulimab plus chemotherapy
Measured: up to 16 weeks
the 1-year progression-free survival (PFS) rate
the proportion of patients who are progression-free after pneumonectomy
Measured: up to one year
Secondary outcomes (5)
the rate of R0 resection
the proportion of R0 resection in patients who receive pneumonectomy
Measured: immediately after the surgery
Progression-free survival (PFS)
The duration from the date of initial treatment to the date of disease progression or death due to any cause
Measured: up to five years
Overall survival (OS)
The duration from the date of initial treatment to the date of death due to any cause
Measured: up to five years
the rate of major pathological response (MPR)
the proportion of patients who achieve MRP among those receiving pneumonectomy
Measured: up to 16 weeks
the rate of pathological complete response (pCR)
the proportion of patients who achieve pCR among those receiving pneumonectomy
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start15 May 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Lung Non-Small Cell CarcinomaStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijia Fang, MD, Zhejiang University
- Investigators
- Weijia Fang, MD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837052
- Sponsor's protocol ID
- CTHLX10
- Status last verified
- Jul 2023
- First submitted
- 17 Apr 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial to Evaluate the Efficiency and Safety of Serplulimab Plus Chemotherapy as Conversion Treatment for Patients With Stage IIIB-IVA Oligometastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05837052
- Acronym / sponsor ID
- CTHLX10
- Keywords
- Unresectable NSCLC, Serplulimab, Conversion treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 May 2023 (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 a phase II, single-arm study to evaluate the efficacy and safety of Serplulimab plus chemotherapy as conversion treatment in patients with stage IIIB-IVA oligometastatic non-small cell lung cancer.
Detailed description
This single-arm, open-label, prospective phase II clinical trial was designed to evaluate the efficacy and safety of Serplulimab plus chemotherapy as conversion treatment in patients with stage IIIB-IVA oligometastatic non-small cell lung cancer.
The primary endpoints were the rate of NSCLC converting to resectable tumors and the 1-year progression-free survival (PFS) rate.The secondary endpoints included the rates of R0 resection, major pathological response (MPR) and pathological complete response (pCR), overall survival (OS) and PFS. Multi-omics analysis will be performed to identify potential biomarkers for treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serplulimab plus chemotherapy | Experimental | Procedure: serplulimab plus chemotherapy as conversion treatmentPatients with unresectable NSCLC will receive 3-4 cycles of serplulimab plus chemotherapy as the conversion treatment (serplulimab 300mg d1 q3w; carboplatin (AUC 5) on day 1, and pemetrexed (500 mg/m2 for adenocar- cinoma) or nab-paclitaxel (260 mg/m2 for squamous carcinoma) d1 q3w), and then curative pneumonectomy will be provided for patients who are suitable for primary tumor resection. Locoregional ablative treatments will be performed for metastatic lesions. Maintenance treatment with PD-1 antibody q3w will continue up to 12 months or disease progression after surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients should voluntarily join this study and sign the informed consent form
- NSCLC patients diagnosed by cytology or histology and not previously receiving anti-tumor treatments (including systemic treatments, local treatments .etc)
- Patients with IIIB - IVA oligometastatic NSCLC : (a) IIIB - IIIC stage (T1-4N2-3): patients are not suitable or refuse to receive upfront surgical resection or radiotherapy; (b) oligometastatic stage IV (T1-3N0-2): radical resection/radiotherapy is feasible for metastatic lesions (the number of metastases being up to 3, and the maximum diameter of metastases being up to 2cm)
- After evaluation by MDT, upfront surgical resection is not the preferred treatment, but after induction systemic treatments, radical resection of the primary tumor is feasible, and radical resection/radiotherapy is feasible for extrathoracic metastases (if any)
- Age from 18 to 75 years old, both male and female
Key exclusion criteria (13 listed)
- NSCLC patients have sensitive EGFR mutation, EML4-ALK fusion or other forms of ALK gene changes
- Patients have previously received immune checkpoint inhibitors such as PD-1/ PD-L1/CTLA4 antibody
- Patients with other primary malignancies within the past 3 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ)
- Patients with active hepatitis B/C
- Patients with any active autoimmune diseases or a history of autoimmune diseases
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 |
|---|---|---|
| serplulimab plus chemotherapy as conversion treatmentPatients with unresectable NSCLC will receive serplulimab plus chemotherapy as conversion treatment, and then curative pneumonectomy will be provided for patients who are suitable for primary tumor resection. Locoregional ablative treatments will be performed for metastatic lesions. | Procedure or surgery | Serplulimab plus chemotherapy |
Primary outcome
the rate of NSCLC converting to resectable tumors
Time frame: up to 16 weeks
the proportion of unresectable NSCLC patients who are converted to being suitable for radical pneumonectomy after 3-4 cycles serplulimab plus chemotherapy
the 1-year progression-free survival (PFS) rate
Time frame: up to one year
the proportion of patients who are progression-free after pneumonectomy
5 secondary outcomes
the rate of R0 resection
Time frame: immediately after the surgery
Progression-free survival (PFS)
Time frame: up to five years
Overall survival (OS)
Time frame: up to five years
the rate of major pathological response (MPR)
Time frame: up to 16 weeks
the rate of pathological complete response (pCR)
Time frame: up to 16 weeks
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 17 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Unresectable Lung Non-Small Cell Carcinoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Active, not recruitingPhase 3
Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
Recurrent Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8
Active, not recruitingPhase 1
Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy
Adult Solid Neoplasm, Bladder Carcinoma
Active, not recruitingObservational study
Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments
Stage IV Non-small Cell Lung Cancer, Stage IV Malignant Melanoma
RecruitingPhase 1/2
A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors
Advanced Solid Tumors With KRAS G12C Mutations, Solid Tumor, Adult
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.
Weijia Fang, MD principal investigator
First Affiliated Hospital of Zhejiang University
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 serplulimab plus chemotherapy as conversion treatment in people with Unresectable Lung Non-Small Cell Carcinoma, run by Zhejiang 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 11 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: looking for participants now, as of the sponsor's last update on 17 Jul 2023. 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 Peng Zhao, MD (+86-18767186629, zhaop@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of NSCLC converting to resectable tumors (time frame: up to 16 weeks). The study lists 2 primary outcomes in all. 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 17 Jul 2023; AzTrials last refreshed its copy on 1 Nov 2026.