Non-Small Cell Lung CancerPhase 2ExampleNCT06604351
Bronchoscopic Cryoablation Combined With Chemo-Immunotherapy in NSCLC With Central Airway Obstruction
A Phase 2 study testing Sintilimab, Nab-Paclitaxel, and Carboplatin in people with Non-Small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
Trial summary
This study aimed to evaluate the efficacy and safety of bronchoscopic cryoablation combined with sintilimab plus platinum-based chemotherapy as First-line Treatment for locally advanced or metastatic NSCLC with central airway obstruction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Sintilimab, Nab-Paclitaxel, and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2024to 31 May 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand the requirements and contents of the clinical trial and provide a signed and dated informed consent form.
- Age≥18 years and≤80 years.
- Histologically or cytologically confirmed and documented locally advanced or metastatic non-small cell lung cancer (NSCLC) without prior systemic therapy and EGFR-sensitive mutations (19del, L858R and T790M).
- Presence of a palliative treatment lesion in the central airway that is amenable to ablation, endoscopically assessed to be≥1/3 obstruction, such as primary or metastatic malignancy to the trachea, main bronchi, intermediate bronchi, or segmental bronchi. corresponding respiratory symptoms or obstructive pneumonia is permission to be included.
- Eastern Cooperative Oncology Group (ECOG) ： 0-2.
- Predicted survival ≥ 12 weeks.
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- Adequate bone marrow hematopoiesis and organ function (cardiac function, hepatic, and renal function).
- Presence of measurable lesions according to RECIST 1.1 criteria.
- Subjects with stable brain metastases may be included in the study.
Who cannot join
- Histological diagnosis of small cell, large cell lung cancer; mixed tumors will be classified based on the primary cell type; if the primary component is small cell, large cell, or neuroendocrine carcinoma, the subject will not be eligible for enrollment; however, mixed adenocarcinoma-squamous cell carcinoma is acceptable. Subjects with driver gene mutations are generally not eligible for enrollment.
- Malignant central airway obstruction with acute dyspnea or severe life-threatening symptoms of malignant airway stenosis, or assessed by the investigator to be unable to tolerate subsequent treatment; extrinsic airway compression; large pleural effusion, severe coughing, massive hemoptysis, dyspnea, or inability to cooperate; severely impaired lung function with a maximal voluntary ventilation (MVV) < 39% or inability to ambulate.
- Prior systemic therapy for locally or metastatic disease.
- Uncorrectable coagulation disorders, severe bleeding tendencies, platelet count < 50 *10^9/L, or severe coagulation dysfunction.
- Presence of symptomatic brain metastases.
- Known severe hypersensitivity to anti-PD-1 monoclonal antibodies or similar drugs (allergic reactions with CTCAE≥ grade 3 toxicity).
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- Subjects with persistent or active infection, including but not limited to hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV).
- Any concurrent malignancy other than basal cell carcinoma or cervical carcinoma in situ. (Patients with a history of malignant tumors but with no evidence of disease for≥ 3 years may be included ).
- Women who are breastfeeding or pregnant.
- Other conditions assessed by the investigator to be 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
Hunan Cancer hospital
Changsha, Hunan
Yongchang Zhang, MD, 13873123436, zhangyongchang@csu.edu.cn
About this study
Official title: The Efficacy and Safety of Bronchoscopic Cryoablation Combined With Sintilimab Plus Platinum-based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic NSCLC With Central Airway Obstruction: A Phase II Study
This study aimed to evaluate the efficacy and safety of bronchoscopic cryoablation combined with sintilimab plus platinum-based chemotherapy as First-line Treatment for locally advanced or metastatic NSCLC with central airway obstruction.
Read the detailed description
This is a prospective interventional clinical study to evaluate the efficacy and safety of bronchoscopic cryoablation combined with sintilimab plus platinum-based chemotherapy as First-line Treatment for locally advanced or metastatic Non-small Cell Lung Cancer with central airway obstruction.
Approximately 39 patients with locally advanced or metastatic NSCLC and central airway obstruction, without EGFR-sensitive mutations (19del, L858R, and T790M), were enrolled and treated with bronchoscopic cryoablation combined with Sintilimab, Nab-Paclitaxel, and Carboplatin until disease progression, intolerable toxicity, or meeting the criteria for discontinuation of the trial drug.
The primary endpoint is the investigator-assessed objective response rate (ORR) of airway tumors. Secondary endpoints include the pathological response rate (PRR) of airway tumors, disease control rate (DCR), improvement rate of FEV1, duration of response (DOR) for airway tumors, progression-free survival (PFS), overall survival (OS), quality of life assessment, and safety. Recruitment for the study is expected to begin in mainland China around October 2024, with the trial anticipated to conclude in October 2027.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Sintilimab, Nab-Paclitaxel, and Carboplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab, Nab-Paclitaxel, and CarboplatinDrug
Cryoablation received at least 2 or more depending on the mass, with 2-3 cycles；Sintilimab 200 mg Q3W plus Nab-Paclitaxel 260mg / m2(Day 1) Q3W + carboplatin AUC 4.25 or 5 (Day 1) Q3W, 4 cycles，until 24 months
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | Bronchial endoscopic cryoablation Receives: Drug: Sintilimab, Nab-Paclitaxel, and Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate of Airway Tumor
The ORR for Objective response of airway tumors after cryoablation combined with immunochemotherapy was evaluated according to the investigator's Solid Tumor Response Assessment Criteria (RECIST) version 1.1, defined as the proportion of subjects who were evaluated for complete response (CR) + partial response (PR) to airway tumors after the first documented treatment
Measured: Time from first dose to last dose, or up to 24 month
Secondary outcomes (8)
Pathological Response Rate of Airway Obstruction
The pathologic response rate of airway tumors obstruction in patients treated with cryoablation combined with immunochemotherapy was evaluated according to the investigator which was defined as the proportion of subjects with endoscopically assessed airway pathologic residual tumors ≤10% after treatment recorded for the first or last time after cryoablation
Measured: Time from first dose to last dose, or up to 24 month
Airway Obstruction Response Control Rate
The DCR for airway tumors obstruction in patients treated with cryoablation combined with immunochemotherapy was assessed according to the investigator's RECIST 1.1, defined as the proportion of subjects evaluated for complete (CR) + partial response (PR) and stable SD for intraairway tumors after the first recorded treatment
Measured: Time from first subject dose to study completion, or up to 36 month
FEV1R improvement rate of airway obstruction
Calculated according to the subjects' pulmonary function measures assessed by the investigator: FEV1 (post-treatment) -FEV1 (pre-treatment)/FEV1 (pre-treatment) *100%
Measured: Time from first subject dose to study completion, or up to 36 month
Airway Obstruction Response Duration
The duration of response in subjects with CR or PR was assessed according to the Solid Tumor Response Assessment Criteria (RECIST) version 1.1 developed by the investigators, defined as the time from the first recorded evaluated airway tumor CR or PR to airway disease progression or death
Measured: Time from first subject dose to study completion, or up to 36 month
Progression-free survival
Progression-free survival of patients treated with cryoablation plus immunochemotherapy was assessed according to the Investigator Response Evaluation criteria (RECIST) version 1.1, defined as the duration of first documented disease progression or death from any cause
Measured: Time from first subject dose to study completion, or up to 36 month
Overall survival
To assess overall survival, it was defined as the first dose at which the subject died from any cause
Measured: Time from first subject dose to study completion, or up to 36 month
Adverse events
Number of participants with adverse events (AEs) according to CTCAE 5.0
Measured: Time from first subject dose to study completion, or up to 36 month
Life quality score
Score according to EORTC QLQ-L30+QLQ-LC13 table
Measured: Time from first subject dose to study completion, or up to 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Sep 2024 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-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
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongchang Zhang, Hunan Province Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604351
- Sponsor's protocol ID
- 20240827
- Acronym
- Example
- Status last verified
- Sep 2024
- First submitted
- 27 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Bronchoscopic Cryoablation Combined With Sintilimab Plus Platinum-based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic NSCLC With Central Airway Obstruction: A Phase II Study
- ClinicalTrials.gov ID
- NCT06604351
- Acronym / sponsor ID
- Example / 20240827
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 19 Sep 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 aimed to evaluate the efficacy and safety of bronchoscopic cryoablation combined with sintilimab plus platinum-based chemotherapy as First-line Treatment for locally advanced or metastatic NSCLC with central airway obstruction.
Detailed description
This is a prospective interventional clinical study to evaluate the efficacy and safety of bronchoscopic cryoablation combined with sintilimab plus platinum-based chemotherapy as First-line Treatment for locally advanced or metastatic Non-small Cell Lung Cancer with central airway obstruction.
Approximately 39 patients with locally advanced or metastatic NSCLC and central airway obstruction, without EGFR-sensitive mutations (19del, L858R, and T790M), were enrolled and treated with bronchoscopic cryoablation combined with Sintilimab, Nab-Paclitaxel, and Carboplatin until disease progression, intolerable toxicity, or meeting the criteria for discontinuation of the trial drug.
The primary endpoint is the investigator-assessed objective response rate (ORR) of airway tumors. Secondary endpoints include the pathological response rate (PRR) of airway tumors, disease control rate (DCR), improvement rate of FEV1, duration of response (DOR) for airway tumors, progression-free survival (PFS), overall survival (OS), quality of life assessment, and safety. Recruitment for the study is expected to begin in mainland China around October 2024, with the trial anticipated to conclude in October 2027.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: Sintilimab, Nab-Paclitaxel, and CarboplatinBronchial endoscopic cryoablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Understand the requirements and contents of the clinical trial and provide a signed and dated informed consent form.
- Age≥18 years and≤80 years.
- Histologically or cytologically confirmed and documented locally advanced or metastatic non-small cell lung cancer (NSCLC) without prior systemic therapy and EGFR-sensitive mutations (19del, L858R and T790M).
- Presence of a palliative treatment lesion in the central airway that is amenable to ablation, endoscopically assessed to be≥1/3 obstruction, such as primary or metastatic malignancy to the trachea, main bronchi, intermediate bronchi, or segmental bronchi. corresponding respiratory symptoms or obstructive pneumonia is permission to be included.
- Eastern Cooperative Oncology Group (ECOG) ： 0-2.
Key exclusion criteria (10 listed)
- Histological diagnosis of small cell, large cell lung cancer; mixed tumors will be classified based on the primary cell type; if the primary component is small cell, large cell, or neuroendocrine carcinoma, the subject will not be eligible for enrollment; however, mixed adenocarcinoma-squamous cell carcinoma is acceptable. Subjects with driver gene mutations are generally not eligible for enrollment.
- Malignant central airway obstruction with acute dyspnea or severe life-threatening symptoms of malignant airway stenosis, or assessed by the investigator to be unable to tolerate subsequent treatment; extrinsic airway compression; large pleural effusion, severe coughing, massive hemoptysis, dyspnea, or inability to cooperate; severely impaired lung function with a maximal voluntary ventilation (MVV) < 39% or inability to ambulate.
- Prior systemic therapy for locally or metastatic disease.
- Uncorrectable coagulation disorders, severe bleeding tendencies, platelet count < 50 *10^9/L, or severe coagulation dysfunction.
- Presence of symptomatic brain metastases.
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 |
|---|---|---|
| Sintilimab, Nab-Paclitaxel, and CarboplatinCryoablation received at least 2 or more depending on the mass, with 2-3 cycles；Sintilimab 200 mg Q3W plus Nab-Paclitaxel 260mg / m2(Day 1) Q3W + carboplatin AUC 4.25 or 5 (Day 1) Q3W, 4 cycles，until 24 months | Drug | group 1 |
Primary outcome
Objective Response Rate of Airway Tumor
Time frame: Time from first dose to last dose, or up to 24 month
The ORR for Objective response of airway tumors after cryoablation combined with immunochemotherapy was evaluated according to the investigator's Solid Tumor Response Assessment Criteria (RECIST) version 1.1, defined as the proportion of subjects who were evaluated for complete response (CR) + partial response (PR) to airway tumors after the first documented treatment
8 secondary outcomes
Pathological Response Rate of Airway Obstruction
Time frame: Time from first dose to last dose, or up to 24 month
Airway Obstruction Response Control Rate
Time frame: Time from first subject dose to study completion, or up to 36 month
FEV1R improvement rate of airway obstruction
Time frame: Time from first subject dose to study completion, or up to 36 month
Airway Obstruction Response Duration
Time frame: Time from first subject dose to study completion, or up to 36 month
Progression-free survival
Time frame: Time from first subject dose to study completion, or up to 36 month
Overall survival
Time frame: Time from first subject dose to study completion, or up to 36 month
Adverse events
Time frame: Time from first subject dose to study completion, or up to 36 month
Life quality score
Time frame: Time from first subject dose to study completion, or up to 36 month
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 Sep 2024.
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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 Sintilimab, Nab-Paclitaxel, and Carboplatin in people with Non-Small Cell Lung Cancer, run by Hunan Province Tumor 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 9 inclusion and 10 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 Sep 2024. 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 Yongchang Zhang (+8613873123436, zhangyongchang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate of Airway Tumor (time frame: Time from first dose to last dose, or up to 24 month). 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 Sep 2024.