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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Extensive-stage Small-cell Lung Cancer
• Intervention / Treatment: Drug: adebrelimab; Drug: famitinib; Drug: chemotherapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yanbin Zhao, MD; Phone Number: 13904811741; Email: zhaoyanbin1978@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immuno-cherapy for extensive small cell lung cancer; Adebrelimab in combination with famitinib and chemotherapy	Drug: adebrelimab; adebrelimab IV; Other Names: SHR-1316; Drug: famitinib; famitinib PO; Other Names: SHR1020; Drug: chemotherapy; chemotherapy IV; Other Names: cisplatin/carboplatin and etoposide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-month progression-free survival	Proportion of disease progression or death from randomization to 6 months of treatment.	up to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Harbin Medical University
• Investigators: Principal Investigator: Yanbin Zhao, MD, Harbin Medical University Cancer Hosptital

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): April 15, 2027

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Famitinib; Small-cell Lung Cancer; Adebrelimab
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Carboplatin; Etoposide; Cisplatin
• Other Study ID Numbers: MA-SCLC-II-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No