Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06306560

Not yet recruiting

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

Interventional

Phase 2

Sponsor: Harbin Medical University

Last Updated: March 12, 2024
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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.

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Treatment Category

Chemotherapy, Targeted Therapy, Checkpoint Inhibitors

Required Mutations

None

Trial Started

March 15, 2024

Last Updated by Sponsor

March 12, 2024

Estimated Completion

March 15, 2027

Contact Study

Name:Yanbin Zhao, MD

Email:zhaoyanbin1978@sina.com

Phone:13904811741

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 (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

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Design Details

AllocationN/A

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll40

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: Adebrelimab in combination with famitinib and chemotherapy

Interventions:

chemotherapy
famitinib
adebrelimab

Outcome Measures

Primary Outcome Measures

6-month progression-free survivalup to 6 months

Proportion of disease progression or death from randomization to 6 months of treatment.

Secondary Outcome Measures

Overall Survivalup to 24 months

Defined as the time from randomization to death from any cause.

Objective Response Rateup 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.

AEsup to 24 months

Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.

12-month progression-free survivalup to 12 months

Proportion of disease progression or death from randomization to 12 months of treatment.

Disease control rateup to 24 months

Disease Control Rate, determined using RECIST v1.1 criteria.

QoLup to 24 months

Defined as time from randomization to deterioration on each of the EORTC QLQ-C30 symptom subscales

Progression-Free-Survivalup 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.