A Study of Adebrelimab Combined With Famitinib and Chemotherapy in the Treatment of ES-SCLC.

Extensive-stage Small-cell Lung Cancer Clinical Trial

Official title:

An Exploratory Clinical Study of Adebrelimab in Combination With Famitinib and Chemotherapy for the Treatment of First-line Extensive Stage Small Cell Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06306560
• Other study ID #: MA-SCLC-II-018
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 15, 2024
• Est. completion date: April 15, 2027

Study information

• Verified date: March 2024
• Source: Harbin Medical University
• Contact: Yanbin Zhao, MD
• Phone: 13904811741
• Email: zhaoyanbin1978[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 15, 2027
• Est. primary completion date: March 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 (ßHCG) 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

Related Conditions & MeSH terms

• Extensive-stage Small-cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• adebrelimab
adebrelimab IV
• famitinib
famitinib PO
• chemotherapy
chemotherapy IV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-month progression-free survival	Proportion of disease progression or death from randomization to 6 months of treatment.	up to 6 months
Secondary	12-month progression-free survival	Proportion of disease progression or death from randomization to 12 months of treatment.	up to 12 months
Secondary	Objective Response Rate	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.	up to 24 months
Secondary	Disease control rate	Disease Control Rate, determined using RECIST v1.1 criteria.	up to 24 months
Secondary	Overall Survival	Defined as the time from randomization to death from any cause.	up to 24 months
Secondary	AEs	Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.	up to 24 months
Secondary	QoL	Defined as time from randomization to deterioration on each of the EORTC QLQ-C30 symptom subscales	up to 24 months
Secondary	Progression-Free-Survival	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.	up to 24 months