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Trial Title:
Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer
NCT ID:
NCT05766800
Condition:
Locally Advanced
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Pemetrexed
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Serplulimab
Description:
Specified dose on specified days
Arm group label:
Downstaged arm with radiotherapy
Arm group label:
Downstaged arm with surgical treatment
Arm group label:
Unresectable arm
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Specified dose on specified days
Arm group label:
Downstaged arm with radiotherapy
Arm group label:
Downstaged arm with surgical treatment
Arm group label:
Unresectable arm
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Specified dose on specified days
Arm group label:
Downstaged arm with radiotherapy
Arm group label:
Downstaged arm with surgical treatment
Arm group label:
Unresectable arm
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
Specified dose on specified days
Arm group label:
Downstaged arm with radiotherapy
Arm group label:
Downstaged arm with surgical treatment
Arm group label:
Unresectable arm
Intervention type:
Drug
Intervention name:
Liposomal paclitaxel
Description:
Specified dose on specified days
Arm group label:
Downstaged arm with radiotherapy
Arm group label:
Downstaged arm with surgical treatment
Arm group label:
Unresectable arm
Intervention type:
Procedure
Intervention name:
Surgery
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.
Arm group label:
Downstaged arm with surgical treatment
Intervention type:
Radiation
Intervention name:
Radiotherapy
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.
Arm group label:
Downstaged arm with radiotherapy
Arm group label:
Unresectable arm
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The patient shall sign the Informed Consent Form.
2. Aged 18 ≥ years.
3. Histological or cytological diagnosis of NSCLC by needle biopsy, and stage IIIB-IIIC
confirmed by imageological examinations (CT, PET-CT or EBUS).
4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
5. Life expectancy is at least 12 weeks.
6. At least 1 measurable lesion according to RECIST 1.1.
7. Patients with good function of other main organs (liver, kidney, blood system, etc.)
8. Patients with normal lung function can tolerate surgery;
9. Without systematic metastasis (including M1a, M1b and M1c);
10. 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.
11. Unsterilized male patients must voluntarily use effective contraception during the
study period not less than 120 days after chemotherapy or the last dose of
Serplulimab (whichever is later).
Exclusion Criteria:
1. 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;
2. 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;
3. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome
requiring systemic treatment;
4. Participants who are allergic to the test drug or any auxiliary materials;
5. Participants with Interstitial lung disease currently;
6. Participants with active hepatitis B, hepatitis C or HIV;
7. Pregnant or lactating women;
8. Participants suffering from nervous system diseases or mental diseases that cannot
cooperate;
9. Participated in another therapeutic clinical study;
10. Other factors that researchers think it is not suitable for enrollment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Peng Zhang, PhD
Email:
zhangpeng1121@tongji.edu.cn
Contact backup:
Last name:
Suyu Wang
Email:
wangsuyv357311854@163.com
Start date:
March 14, 2023
Completion date:
April 1, 2027
Lead sponsor:
Agency:
Shanghai Pulmonary Hospital, Shanghai, China
Agency class:
Other
Source:
Shanghai Pulmonary Hospital, Shanghai, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05766800
