- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04338620
Camrelizumab Combined With Albumin-bound Paclitaxel and Platinum in Neoadjuvant Treatment of Resectable NSCLC
An Explorative Study on Camrelizumab Combined With Albumin-bound Paclitaxel and Platinum in Neoadjuvant Treatment of Resectable Non-small-cell Lung Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Li Jie, PhD
- Phone Number: +86-029-84777777
- Email: leijiemd@163.com
Study Locations
-
-
Shaanxi
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Xi'an, Shaanxi, China, 710038
- The Fourth Military Medical University Tangdu Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age :18 Years to 70 Years (Adult, Older Adult)
- ECOG physical score status of 0 or 1 points;
- expected survival time ≥ 12 weeks;
- Pathological diagnosis with StageIIIA-IIIB NSCLC;
- According to the eighth edition of the AJCC/UICC TNM staging system, patients was pathological diagnosed with Stage III-N2 clinically resectable NSCLC.
- Patients with at least one evaluable or measurable lesions as per RECIST version 1.1 (CT scan length and diameter of tumor lesion≥10mm,CT scan of lymph node lesion was short diameter≥15mm;)
- Patients were newly diagnosed with non-small cell lung cancer, without radiotherapy, chemotherapy, surgery or molecule-targeted treatment.
- Patients must have enough cardiopulmonary function for the expected pulmonary resections for lung cancer.
- The main organ function meets the following criteria:1) blood routine:a. ANC ≥ 1.5×109/L; b. PLT ≥ 100×109/L; c. HB ≥ 90 g/L; 2) Blood biochemistry:TBIL ≤ 1.5×ULN;ALT、AST≤ 2.5×ULN;sCr≤1.5×ULN; 3) Blood coagulation: INR≤1.5×ULN and APTT≤1.5×ULN,endogenous creatinine clearance rate≥50ml/min(Cockcroft-Gault formula);
- Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 3 months post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 3 months post the last administration of study drug;
- Patient has to voluntarily join the study and sign the Informed Consent Form for the study.
Exclusion Criteria:The subject must be excluded from participating in the trial if the subject:
- Patients with brain metastasis
- Patients with autoimmune disease, or a history of autoimmune disease including but not limited to the following: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism which can be included after hormone replacement therapy; Subjects with childhood asthma have been completely alleviated and without any intervention or vitiligo in adulthood can be included.
- Subjects who need medical intervention with bronchodilators cannot be included.
- Subjects with congenital or acquired immunodeficiency such as HIV infection, active hepatitis B (HBV DNA ≥ 2000 IU/mL), hepatitis C (hepatitis C antibody is positive);
- Subjects with a condition requiring other immunosuppressive medications before 14 days of study drug administration firstly, not including inhaled corticosteroids or physiological doses of systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents).
- Has received a live vaccine within 4 weeks of planned start of study therapy.
- Other malignancies have been diagnosed within 3 years prior to the first use of the study drug; 8. Patients with a current or history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and severe impairment of lung function.
- Patients with hypertension that is difficult to control (systolic blood pressure ≥140 mmHg and diastolic blood pressure ≥90 mmHg);
- patients with myocardial ischemia and myocardial infarction above class II (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms);
- Severe infection within 4 weeks before the first administration (such as intravenous drip of antibiotics, antifungal drugs or antiviral drugs), or fever of unknown origin (> 38.5 ℃) within 4 weeks before the first administration.
- allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- Pregnant or nursing women; 14. Patients with a history of hypersensitivity to any of the study drugs, similar drugs, or excipients.
- Participated in other clinical trials within 4 weeks; 16. Patients with the history of drug abused or alcohol.
- The investigator believes that there are any conditions that may damage the subject or result in the subject being unable to meet or perform the research request;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A: Experimental Group
Participants receive totally 3 cycles of camrelizumab combined with albumin-bound paclitaxel and Cisplatin/carboplatin/Nedaplatin treatment during preoperative period, every 3 weeks for up to 3 cycles.
|
Experimental Group:camrelizumab、albumin-bound paclitaxel and platinum.
Camrelizumab will be administered as a 30-minute IV infusion Q3W at a dose of 200mg on day1 of each cycle.
Albumin-bound paclitaxel will be administered as a 30-minute IV infusion Q3W at a dose of 130 mg/m2 on day1 and day8 of each cycle.
Platinum included Cisplatin/carboplatin/Nedaplatin
|
Active Comparator: B: Control group
Participants receive totally 3 cycles of albumin-bound paclitaxel combined with Cisplatin/carboplatin/Nedaplatin treatment during preoperative period, every 3 weeks for up to 3 cycles.
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Control group:albumin-bound paclitaxel and platinum. Albumin-bound paclitaxel will be administered as a 30-minute IV infusion Q3W at a dose of 130 mg/m2 on day1 and day8 of each cycle. Platinum included Cisplatin/carboplatin/Nedaplatin |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pathological complete response (pCR)
Time Frame: The day of the surgery
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no residual tumor cells in the surgically resected tumor specimen and all sampled regional lymph nodes after neoadjuvant treatment.
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The day of the surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
main pathology rate (MPR)
Time Frame: The day of the surgery
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Major pathological response rate (MPR): defined as ≤ 10% of residual tumor cells in the surgically resected tumor specimen and sampled regional lymph nodes after neoadjuvant treatment.
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The day of the surgery
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Objective Response Rate (ORR)
Time Frame: pre-operation
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Objective response rate (ORR): defined as the proportion of patients whose tumor size shrinks to predefined values,which including cases of CR and PR.
Objective tumor response will be assessed using RECIST 1.1.
Subjects must have measurable tumor lesions at baseline, and the response evaluation criteria are classified as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) according to RECIST 1.1.
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pre-operation
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Event-free Survival (EFS)
Time Frame: Event-free survival (EFS): defined as the time from the randomization until the date of first documented progression or recurrence or date of death from any cause, whichever came first, assessed up to 100 months
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Event-free survival (EFS): defined as the time from the randomization to the first occurrence of disease progression or recurrence, or death (due to any cause).
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Event-free survival (EFS): defined as the time from the randomization until the date of first documented progression or recurrence or date of death from any cause, whichever came first, assessed up to 100 months
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Assess adverse events
Time Frame: 90 days
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Assess all adverse events according to the NCI Common Terminology Criteria for (NCI CTCAE) v5.
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90 days
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
type of surgery、R0 Resection、Surgical approach、Duration from final treatment to surgery、Duration of surgery、Length of hospital stay and rate of peri- and post-operative complications
Time Frame: within 30 days of surgery
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enumeration data:type of surgery、R0 Resection、Surgical approach measurement data:Duration from final treatment to surgery、Duration of surgery、Length of hospital stay. Peri- and post-operative complications reported up to 30 days after surgery. The Clavien-Dindo scale classifies peri- and post-operative complications into 5 grades.complications (within 30 days of surgery) in subjects treated with camrelizumab plus chemotherapy compared to those treated with chemotherapy alone. |
within 30 days of surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jiang Tao, PhD, The Fourth Military Medical University Tangdu Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- XBSX-L1-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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