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Trial Title:
Effect of Time-of-Day (ToD) for Immunochemotherapy on PFS in NSCLC
NCT ID:
NCT05549037
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pembrolizumab
Conditions: Keywords:
Immunochemotherapy
Time of day
Non-small Cell Lung Cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
One for morning group, the patients in this group were treated with chemotherapy plus
pembrolizumab or sintilimab before 15:00. One for afternoon group, the patients in this
group were treated with chemotherapy plus pembrolizumab or sintilimab after 15:00.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pembrolizumab, Sintilimab
Description:
One for morning group, the patients in this group were treated with immunochemotherapy
before 15:00. One for afternoon group, the patients in this group were treated with
immunochemotherapy after 15:00.
Arm group label:
Arm A: Morning group
Arm group label:
Arm B: Afternoon group
Other name:
time-of-day of administration of immunochemotherapy
Summary:
This study aims to explore time-of-day of administration of immunochemotherapy on the
efficacy for treatment naive advanced non-small cell lung cancer.
Detailed description:
All the advanced NSCLC patients who were treated with chemotherapy plus pembrolizumab or
sitilimab will be randomized to two groups. One for morning group, the patients in this
group were treated with chemotherapy plus pembrolizumab or sintilimab before 15:00. One
for afternoon group, the patients in this group were treated with chemotherapy plus
pembrolizumab or sintilimab after 15:00.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Understand the requirements and contents of the clinical trial, and provide a signed
and dated informed consent form.
2. Age ≥ 18 years.
3. Histopathology or cytology confirmed and recorded local progression or metastatic
non-small cell lung cancer without systemic treatment.
4. EGFR, ALK and ROS1 mutations negative confirmed by an accredited local laboratory.
5. ECOG 0-1.
6. Predicted survival ≥ 12 weeks.
7. Adequate bone marrow hematopoiesis and organ function
8. Presence of measurable lesions according to RECIST 1.1.
9. Subjects with stable brain metastases may be included in the study.
Exclusion Criteria:
1. Prior systemic therapy for locally advanced or metastatic disease.
2. Subjects who have received any of the following treatments must be excluded:
- Ant Treatment with chemotherapy or molecules such as EGFR, VEGFR antibodies
within 4 weeks prior to the first dose of study drug.
- Have received radiation within 14 days prior to the first dose or have not
recovered from radiation-related toxicity. Chest and extra-brain palliative
radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may
be performed 7 days prior to the first dose.
3. Presence of spinal cord compression or meningeal metastasis.
4. History of other malignant tumors within 2 years.
5. Adverse events (except alopecia of any degree) of CTCAE > grade 1 due to prior
treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
6. History of stroke or intracranial hemorrhage within 6 months prior to the first
dose.
7. The presence of any severe or poorly controlled systemic disease, including poorly
controlled hypertension and active bleeding in the judgment of the investigator.
8. Subjects with persistent or active infection, including but not limited to hepatitis
B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19
infection.
9. Heart-related diseases or abnormalities
10. Past history of interstitial lung disease, drug-induced interstitial lung disease,
radiation pneumonitis requiring steroid therapy or interstitial lung disease with
active clinical symptoms, immune pneumonia caused by immunotherapy.
11. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty
swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due
to previous bowel resection.
12. Live vaccine was given 2 weeks before the first medication.
13. Women who are breastfeeding or pregnant.
14. Hypersensitivity to the test drug and the ingredients.
15. Other conditions assessed by the investigator to be unsuitable for participation in
the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongchang Zhang, MD
Phone:
+86 731 89762323
Email:
zhangyongchang@csu.edu.cn
Contact backup:
Last name:
Yongchang Zhang, MD
Phone:
+8613873123436
Email:
zhangyongchang@csu.edu.cn
Investigator:
Last name:
Yongchang Zhang, MD
Email:
Principal Investigator
Start date:
September 23, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Hunan Province Tumor Hospital
Agency class:
Other
Source:
Hunan Province Tumor Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05549037
