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

Phase 2

Not yet recruiting

• Conditions: Extensive-stage Small-cell Lung Cancer
• Interventions: Drug: adebrelimab; Drug: famitinib; Drug: chemotherapy

• Registration Number: NCT06306560
• Lead Sponsor: Harbin Medical University

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.

Study Timeline

• Study First Submitted: 2024-02-29
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-05
• Last Update Submitted: 2024-03-05
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Study Start: 2024-03-15
• Primary Completion: 2027-03-15
• Study Completion: 2027-04-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immuno-cherapy for extensive small cell lung cancer	chemotherapy	Adebrelimab in combination with famitinib and chemotherapy
Immuno-cherapy for extensive small cell lung cancer	adebrelimab	Adebrelimab in combination with famitinib and chemotherapy
Immuno-cherapy for extensive small cell lung cancer	famitinib	Adebrelimab in combination with famitinib and chemotherapy

Primary Outcome Measures

Name	Time	Method
6-month progression-free survival	up to 6 months	Proportion of disease progression or death from randomization to 6 months of treatment.

Secondary Outcome Measures

Name	Time	Method
12-month progression-free survival	up to 12 months	Proportion of disease progression or death from randomization to 12 months of treatment.
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.
AEs	up to 24 months	Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
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.