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Trial Title:
A Single-arm Pilot Study of First-line Treatment With Carbognilumab Combined With Chemotherapy in Patients With STK11-mutated Advanced or Postoperative Recurrent Non-small Cell Lung Cancer
NCT ID:
NCT06331650
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
cadonilimab
Description:
Cardunnilizumab: the recommended dose is 10mg/kg every 3 weeks on the first day of each
cycle; Discontinuation of the drug may be considered if intolerable adverse reactions
occur.
Arm group label:
cadonilimab
Summary:
To evaluate the safety and tolerability of carbognilumab combined with chemotherapy as
the first-line treatment for patients with STK11 mutated advanced or postoperative
recurrent non-small cell lung cancer (NSCLC).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. voluntary participation in clinical research; Fully understand and Informed the
study and sign the Informed Consent Form (ICF); Be willing to follow and be able to
complete all trial procedures.
2. Age ≥18 years old and ≤75 years old when signing ICF.
3. histologically or cytologically confirmed advanced or postoperative recurrent
non-small cell lung cancer (AJCC 8th edition).
4. STK11 mutations were detected by NGS, and no other sensitive mutations could be
targeted therapy (including EGFR, ALK, ROS1, RET, c-Met, HER2, BRAF gene
rearrangement, fusion, amplification, and skipping).
5. The patient had not received systemic antitumor therapy.
6. Patients who had received one prior chemotherapy regimen were allowed, regardless of
whether chemotherapy was administered before, after, or concurrently with targeted
therapy.
7. Patients receiving adjuvant or neoadjuvant therapy were allowed if
adjuvant/neoadjuvant therapy had been completed at least 12 months before diagnosis
of advanced or postoperative recurrent NSCLC.
8. The interval between the end of previous nonsystemic antitumor therapy and the start
of study medication had to be 4 weeks or more. Treatment-related AE recovered to
CTCAE 4.03≤ grade 1 (except grade 2 alopecia).
9. have at least one measurable target lesion as assessed by the investigator according
to iRECIST requirements within 4 weeks before enrollment.
10. If available, patients can provide eligible tumor tissue for PD-L1 expression level
measurement.
11. an ECOG PS score of 0 or 1 within 7 days before the first dose of study medication.
12. predicted survival time ≥12 weeks (3 months).
13. had good major organ function, defined as meeting the following criteria, and had
not received blood transfusions, albumin, recombinant human thrombopoietin, or
colony-stimulating factor (CSF) within 14 days before the first dose of study
medication.
14. Female patients must meet one of the following conditions:
1) menopause, defined as absence of menses for at least 1 year and no confirmed cause
other than menopause, or (2) having undergone sterilization (removal of ovaries
and/or uterus) 3) be fertile, provided that: Patients had to have a negative serum
pregnancy test within 7 days before randomization and agree to use contraception
with an annual failure rate of <1% or to abstain from heterosexual intercourse for
at least 120 days from the date of written informed consent until the last dose of
trial drug was administered. At least 150 days after the last dose of chemotherapy)
(contraceptive methods with an annual failure rate of <1% include bilateral tubal
ligation, male sterilization, proper use of ovulation-suppressing hormonal
contraceptives, hormone-releasing intrauterine devices, and copper intrauterine
devices or condoms), and Do not breastfeed.
15.Male patients had to agree to either abstain from sex (avoid heterosexual intercourse)
or to use contraception, as specified by either abstinence or use of condoms to prevent
exposure of the drug to the embryo during chemotherapy
(paclitaxel/pemetrexed/carboplatin) for the duration of treatment with a woman of
reproductive age or a pregnant partner and for at least 150 days after the last dose of
chemotherapy. Regular abstinence (e.g., calendar day, ovulation, basal body temperature,
or postovulatory methods of contraception) and in vitro ejaculation are ineligible
methods of contraception.
Exclusion Criteria:
1. received systemic therapy for advanced NSCLC within 4 weeks after enrollment;
2. the subjects had a history or concurrent history of other malignant tumors (except
cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).
3. candidates for or prior recipients of organ or bone marrow transplantation.
4. uncontrollable pleural, pericardial, or ascites with appropriate interventions.
5. subjects with clinically symptomatic CNS metastases (e.g., brain edema, need for
hormonal intervention, or progression of brain metastases). Patients who had
received previous treatment for brain or meningeal metastases were eligible if they
had been clinically stable (on MRI) for at least 2 months and had stopped systemic
hormone therapy (at a dose of >10mg per day of prednisone or other iso-efficacy
hormones) for more than 2 weeks.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Guangzhou Medical University
Address:
City:
Guangdong
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
zhou chegnzhi, doctor
Phone:
13560351186
Email:
doctorzcz@163.com
Start date:
August 9, 2023
Completion date:
October 2025
Lead sponsor:
Agency:
Guangzhou Institute of Respiratory Disease
Agency class:
Other
Source:
Guangzhou Institute of Respiratory Disease
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06331650