Back to resultsInduction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer
Primary Purpose
Locally Advanced, Non-small Cell Lung Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Serplulimab
Carboplatin
Pemetrexed
Nab-paclitaxel
Surgery
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced
Eligibility Criteria
Inclusion Criteria: The patient shall sign the Informed Consent Form. Aged 18 ≥ years. Histological or cytological diagnosis of NSCLC by needle biopsy, and stage IIIB-IIIC confirmed by imageological examinations (CT, PET-CT or EBUS). Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1. Life expectancy is at least 12 weeks. At least 1 measurable lesion according to RECIST 1.1. Patients with good function of other main organs (liver, kidney, blood system, etc.) Patients with normal lung function can tolerate surgery; Without systematic metastasis (including M1a, M1b and M1c); Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of Serplulimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative. Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of Sintilimab (whichever is later). Exclusion Criteria: Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment; Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases; With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment; Participants who are allergic to the test drug or any auxiliary materials; Participants with Interstitial lung disease currently; Participants with active hepatitis B, hepatitis C or HIV; Pregnant or lactating women; Participants suffering from nervous system diseases or mental diseases that cannot cooperate; Participated in another therapeutic clinical study; Other factors that researchers think it is not suitable for enrollment.
Sites / Locations
- Shanghai Pulmonary HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Downstaged arm with surgical treatment
Downstaged arm with radiotherapy
Unresectable arm
Arm Description
In this arm, patients with tumors resectable after chemoimmunotherapy will receive surgical treatment in department of thoracic surgery.
In this arm, patients with tumors resectable after chemoimmunotherapy will receive radiotherapy in department of medical oncology.
In this arm, patients with tumors still unresectable after chemoimmunotherapy will receive therapy in department of medical oncology.
Outcomes
Primary Outcome Measures
Event-free survival (EFS)
Event-free survival (EFS) is defined as the length of time (months) from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Secondary Outcome Measures
Objective response rate (ORR)
It refers to the proportion of patients who have had a complete response or partial response (according to RECIST1.1) as confirmed by CT evaluation after 3 weeks in all patients who have completed the neoadjuvant therapy. Only patients with measurable lesions at baseline will be analyzed.
Major pathologic response (MPR)
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery
Progression-free survival (PFS)
It refers to the time (months) from the first administration of drug in this study to the disease progression or death (including any cause of death in the case of no progression) as recorded in CRF, regardless of whether the patient exits from the treatment or receives other anti-cancer treatment before progression.
Disease-free survival (DFS)
It refers to the time (months) from radical surgery to relapse or death of a participant due to disease progression. In the case of a patient who still survives at the time of analysis, the latest evaluation date will be used for interpolation (censoring).
Overall survival (OS)
It is defined as the time (months) 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.
Duration of response (DOR)
It is defined as the time from the first time of partial response or complete response to progressive disease via RECIST1.1.
Disease-control rate (DCR)
It is defined as the rate of stable disease, partial response, or complete response via RECIST1.1.
R0 rate
It is defined as the rate of complete resection with no residual tumor cell in the resection margin.
Severe adverse event (SAE) rate
It is defined as the frequency of severe adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.
Health related quality of life (HRQol)
The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 & LC13, Version 3). EORTC's QLQ-C30 & LC13 (V3.0) is a core scale for lung cancer patients, with a total of 43 items. Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options. The other items are divided into 4 grades: Not at All, A Little, Quite a Bit, and Very Much, assigned with 1 to 4 scores respectively. The higher score, the worse quality.
Full Information
NCT ID
NCT05766800
First Posted
February 28, 2023
Last Updated
March 14, 2023
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
1. Study Identification
Unique Protocol Identification Number
NCT05766800
Brief Title
Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer
Official Title
Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer: A Randomised Controlled, Open-label, Phase 2 Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
April 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
For unresectable locally-advanced non-small cell lung cancer, chemoradiotherpay plus immunotherapy is recommended by PACIFIC trial. However, it is unclear whether surgery can provide survival benefit for patients with tumors initially unresectable transformed into resectable ones after chemoimmunotherapy. This trial aims to investigate the efficacy and safety of the therapeutic regimen of chemoimmunotherapy plus surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced, Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Downstaged arm with surgical treatment
Arm Type
Experimental
Arm Description
In this arm, patients with tumors resectable after chemoimmunotherapy will receive surgical treatment in department of thoracic surgery.
Arm Title
Downstaged arm with radiotherapy
Arm Type
Active Comparator
Arm Description
In this arm, patients with tumors resectable after chemoimmunotherapy will receive radiotherapy in department of medical oncology.
Arm Title
Unresectable arm
Arm Type
Other
Arm Description
In this arm, patients with tumors still unresectable after chemoimmunotherapy will receive therapy in department of medical oncology.
Intervention Type
Drug
Intervention Name(s)
Serplulimab
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Intervention Description
Specified dose on specified days
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Patients with stage IIIB-IIIC non-small cell lung cancer are treated with nab-paclitaxel/pemetrexed plus carboplatin and serplulimab for 4 cycles. Those with downstaged and resectable tumors after chemoimmunotherapy are randomised into surgical treatment arm and radiotherapy arm, and those with tumors still unresectable after chemoimmunotherapy will receive non-surgical treatment in department of medical oncology in the third arm.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Patients with stage IIIB-IIIC non-small cell lung cancer are treated with nab-paclitaxel/pemetrexed plus carboplatin and serplulimab for 4 cycles. Those with downstaged and resectable tumors after chemoimmunotherapy are randomised into surgical treatment arm and radiotherapy arm, and those with tumors still unresectable after chemoimmunotherapy will receive non-surgical treatment in department of medical oncology in the third arm.
Primary Outcome Measure Information:
Title
Event-free survival (EFS)
Description
Event-free survival (EFS) is defined as the length of time (months) from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Time Frame
Up to 30 months
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
It refers to the proportion of patients who have had a complete response or partial response (according to RECIST1.1) as confirmed by CT evaluation after 3 weeks in all patients who have completed the neoadjuvant therapy. Only patients with measurable lesions at baseline will be analyzed.
Time Frame
Up to 4 months
Title
Major pathologic response (MPR)
Description
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery
Time Frame
up to 5 months
Title
Progression-free survival (PFS)
Description
It refers to the time (months) from the first administration of drug in this study to the disease progression or death (including any cause of death in the case of no progression) as recorded in CRF, regardless of whether the patient exits from the treatment or receives other anti-cancer treatment before progression.
Time Frame
up to 60 months
Title
Disease-free survival (DFS)
Description
It refers to the time (months) from radical surgery to relapse or death of a participant due to disease progression. In the case of a patient who still survives at the time of analysis, the latest evaluation date will be used for interpolation (censoring).
Time Frame
up to 60 months
Title
Overall survival (OS)
Description
It is defined as the time (months) 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.
Time Frame
up to 60 months
Title
Duration of response (DOR)
Description
It is defined as the time from the first time of partial response or complete response to progressive disease via RECIST1.1.
Time Frame
up to 60 months
Title
Disease-control rate (DCR)
Description
It is defined as the rate of stable disease, partial response, or complete response via RECIST1.1.
Time Frame
up to 60 months
Title
R0 rate
Description
It is defined as the rate of complete resection with no residual tumor cell in the resection margin.
Time Frame
up to 5 months
Title
Severe adverse event (SAE) rate
Description
It is defined as the frequency of severe adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.
Time Frame
up to 6 months
Title
Health related quality of life (HRQol)
Description
The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 & LC13, Version 3). EORTC's QLQ-C30 & LC13 (V3.0) is a core scale for lung cancer patients, with a total of 43 items. Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options. The other items are divided into 4 grades: Not at All, A Little, Quite a Bit, and Very Much, assigned with 1 to 4 scores respectively. The higher score, the worse quality.
Time Frame
up to 5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient shall sign the Informed Consent Form.
Aged 18 ≥ years.
Histological or cytological diagnosis of NSCLC by needle biopsy, and stage IIIB-IIIC confirmed by imageological examinations (CT, PET-CT or EBUS).
Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
Life expectancy is at least 12 weeks.
At least 1 measurable lesion according to RECIST 1.1.
Patients with good function of other main organs (liver, kidney, blood system, etc.)
Patients with normal lung function can tolerate surgery;
Without systematic metastasis (including M1a, M1b and M1c);
Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of Serplulimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of Sintilimab (whichever is later).
Exclusion Criteria:
Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
Participants who are allergic to the test drug or any auxiliary materials;
Participants with Interstitial lung disease currently;
Participants with active hepatitis B, hepatitis C or HIV;
Pregnant or lactating women;
Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
Participated in another therapeutic clinical study;
Other factors that researchers think it is not suitable for enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Zhang, PhD
Phone
02165115006
Email
zhangpeng1121@tongji.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Suyu Wang
Email
wangsuyv357311854@163.com
Facility Information:
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Zhang, PhD
Email
zhangpeng1121@tongji.edu.cn
First Name & Middle Initial & Last Name & Degree
Suyu Wang
Email
wangsuyv357311854@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The researchers will consider whether IPD is available to other researchers only after the paper is published.
Learn more about this trial
Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer
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