Extensive-stage Small-cell Lung Cancer
Conditions
Keywords
Adebrelimab, Famitinib, Small-cell Lung Cancer
Brief summary
This is a single arm, multi-center, phase II trial to evaluate the efficacy, and safety of adebrelimab combined with famitinib and chemotherapy for the treatment of first-line extensive stage small cell lung cancer.
Detailed description
This study plans to recruit 40 patients with extensive-stage small cell lung disease who have not received treatment, observe and evaluate the effectiveness and safety of adebrelimab combined with famitinib and chemotherapy.
Interventions
DRUGadebrelimab
adebrelimab IV
DRUGfamitinib
famitinib PO
DRUGchemotherapy
chemotherapy IV
Sponsors
Harbin Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18-80 years old, male or female 2. Patients with pathologically confirmed extensive stage small cell lung cancer (according to the Veterans Administration Lung Study Group, VALG staging) 3. Never received prior systemic therapy for extensive stage small cell lung cancer 4. Have a measurable tumour target lesion (meeting RECIST 1.1 criteria) 5. Expected survival \> 3 months 6. ECOG PS: 0-1 points 7. Normal function of major organs 8. Women of childbearing potential must undergo a negative pregnancy test (βHCG) prior to initiation of treatment, and women of childbearing potential and men (who are sexually active with women of childbearing potential) must agree to use effective contraception uninterruptedly for the duration of the treatment period and for 6 months after the administration of the last therapeutic dose 9. Patients voluntarily enrolled in this study by signing an informed consent form
Exclusion criteria
1. Previous or concurrent other malignant tumours within 5 years, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial or non-invasive bladder cancer 2. Active tuberculosis infection, or a history of previous tuberculosis infection 3. Uncontrolled, symptomatic brain metastases that are not effectively controlled or a history of psychiatric illness that cannot be easily controlled or severe intellectual or cognitive dysfunction 4. Subjects with active, known or suspected autoimmune disease, hypothyroidism requiring only hormone replacement therapy, skin disorders not requiring systemic therapy (e.g., vitiligo, psoriasis, or alopecia areata) may be eligible for enrolment 5. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage 6. Subjects with the presence of any severe and/or uncontrolled disease 7. Imaging showing tumour invasion of large vessels or poor demarcation from large vessels 8. Susceptibility to bleeding, risk of hemoptysis, and history of significant coagulation disorders 9. History of psychotropic substance abuse, alcoholism or drug addiction 10. Active hepatitis (Hepatitis B reference: HBsAg positive with HBV DNA test value exceeding the upper limit of normal value Hepatitis C reference HCV antibody positive with HCV viral titre test value exceeding the upper limit of normal value) 11. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive 12. Patients who are unable to comply with the trial protocol or who are unable to cooperate with follow-up visits 13. Patients who, in the opinion of the investigator, should not be enrolled in the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-month progression-free survival | up to 6 months | Proportion of disease progression or death from randomization to 6 months of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | up to 24 months | Determined using RECIST v1.1 criteria, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment. |
| Disease control rate | up to 24 months | Disease Control Rate, determined using RECIST v1.1 criteria. |
| Overall Survival | up to 24 months | Defined as the time from randomization to death from any cause. |
| 12-month progression-free survival | up to 12 months | Proportion of disease progression or death from randomization to 12 months of treatment. |
| QoL | up to 24 months | Defined as time from randomization to deterioration on each of the EORTC QLQ-C30 symptom subscales |
| Progression-Free-Survival | up to 24 months | Defined as the time from randomization to the first occurrence of disease progression with use of RECIST v1.1 or death from any cause, whichever occurs first. |
| AEs | up to 24 months | Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. |
Contacts
Primary ContactYanbin Zhao, MD
Outcome results
None listed