To hear about similar clinical trials, please enter your email below
Trial Title:
Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung Cancer
NCT ID:
NCT06121505
Condition:
Lung Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma, Squamous Cell
Conditions: Keywords:
SBRT
Immunotherapy
LDRT
Lung Squamous Cell Carcinoma
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:
Radiation
Intervention name:
low-dose radiation therapy and stereotactic body radiation therapy
Description:
Patients will receive radiation therapy.
Arm group label:
Radiotherapy combined with sintilimab and chemotherapy
Other name:
RT
Intervention type:
Drug
Intervention name:
chemotherapy
Description:
Patients will receive sintilimab combined with standard platinum-based doublet
chemotherapy for a total of 4 cycles. Patients subsequently received maintenance
treatment with sintilimab, and continued treatment until disease progression (PD),
intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor
treatments, death, or other circumstances that should stop treatment as specified in the
protocol. Whichever occurs first. The maximum treatment time with sintilimab is 24 months
(or 35 cycles).
Arm group label:
Radiotherapy combined with sintilimab and chemotherapy
Arm group label:
Sintilimab+Chemotherapy
Other name:
standard platinum-containing double-drug chemotherapy
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
Patients will receive sintilimab combined with standard platinum-based doublet
chemotherapy for a total of 4 cycles. Patients subsequently received maintenance
treatment with sintilimab, and continued treatment until disease progression (PD),
intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor
treatments, death, or other circumstances that should stop treatment as specified in the
protocol. Whichever occurs first. The maximum treatment time with sintilimab is 24 months
(or 35 cycles).
Arm group label:
Radiotherapy combined with sintilimab and chemotherapy
Arm group label:
Sintilimab+Chemotherapy
Summary:
This is a randomized, controlled, open-label, multicenter phase II clinical trial
comparing the efficacy and safety of low-dose radiation therapy and stereotactic body
radiation therapy combined with PD-1 inhibitor (sintilimab) and standard platinum-based
doublet chemotherapy versus PD-1 inhibitor (sintilimab) combined with standard
platinum-based doublet chemotherapy as first-line treatment in patients with locally
advanced or metastatic squamous cell lung cancer.
There will be 57 subjects in the experimental group and 57 subjects in the control group,
with a total of 114 subjects.
Detailed description:
This is a randomized, controlled, open-label, multicenter phase II clinical trial
comparing the efficacy and safety of low-dose radiation therapy and stereotactic body
radiation therapy combined with PD-1 inhibitor (sintilimab) and standard platinum-based
doublet chemotherapy versus PD-1 inhibitor (sintilimab) combined with standard
platinum-based doublet chemotherapy as first-line treatment in patients with locally
advanced or metastatic squamous cell lung cancer. Patients with previously untreated,
locally advanced or metastatic (unresectable or not eligible for definitive
chemoradiotherapy, stage IIIB-IV) squamous cell lung cancer who have signed informed
consent will be screened for eligibility. Qualified subjects who meet the inclusion
criteria will be randomly assigned at a 1:1 ratio to the experimental group (radiation
therapy plus sintilimab and chemotherapy) or the control group (sintilimab plus
chemotherapy). Based on sample size estimation according to statistical hypotheses, there
will be 57 subjects in the experimental group and 57 subjects in the control group, with
a total of 114 subjects. Subjects in the experimental group will receive radiation
therapy. Within 1 week after radiation therapy, they will receive treatment with
sintilimab combined with standard platinum-based doublet chemotherapy. Chemotherapy
combined with immunotherapy will consist of a total of 4 cycles. Patients will
subsequently receive maintenance therapy with sintilimab. Subjects in the control group
will receive treatment with sintilimab combined with standard platinum-based doublet
chemotherapy, consisting of a total of 4 cycles. Patients will subsequently receive
maintenance therapy with sintilimab. The primary efficacy endpoint of this study is
objective response rate (ORR), as assessed by investigators according to Response
Evaluation Criteria in Solid Tumors (RECIST v1.1).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years old and ≤ 75 years old;
2. Histologically or cytologically confirmed squamous cell lung cancer, imaging
confirmed locally advanced or metastatic disease (unresectable or not eligible for
definitive chemoradiotherapy, stage IIIB-IV);
3. According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there
is at least one imaging measurable lesion;
4. Enough to provide quality control qualified tumor tissue or cell wax blocks to
detect PD-L1 expression;
5. Have not received any systemic anti-tumor treatment for locally advanced or
metastatic disease in the past;
Exclusion Criteria:
1. The pathology is small cell lung cancer (SCLC), including lung cancer mixed with
SCLC and non-small cell lung cancer (NSCLC)；
2. The pathology is lung adenocarcinoma, including lung cancer mixed with lung
adenocarcinoma and lung squamous cell carcinoma;
3. EGFR gene sensitive mutation or ALK fusion positive or ROS1 fusion positive;
4. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2
drugs or another drug that stimulates or synergistically inhibits T cell receptors;
5. Pregnant or lactating women;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610044
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianxin Xue
Phone:
+86 189 8225 1798
Email:
killercell@163.com
Start date:
March 1, 2024
Completion date:
February 28, 2027
Lead sponsor:
Agency:
Sichuan University
Agency class:
Other
Collaborator:
Agency:
Innovent Biologics (Suzhou) Co. Ltd.
Agency class:
Industry
Source:
Sichuan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06121505
