Clinical trial · Interventional
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
NCT06306560CI-TRIAL-00074945not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extensive-stage Small-cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adebrelimab | Drug | Adebrelimab | ALIAS |
| chemotherapy | Drug | Chemotherapy | ALIAS |
| famitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Immuno-cherapy for extensive small cell lung cancer
- description
- Adebrelimab in combination with famitinib and chemotherapy
- interventionNames
- Drug: adebrelimab
- Drug: famitinib
- Drug: chemotherapy
Primary outcomes (1)
- measure
- 6-month progression-free survival
- timeFrame
- up to 6 months
- description
- Proportion of disease progression or death from randomization to 6 months of treatment.
Secondary outcomes (7)
- measure
- 12-month progression-free survival
- timeFrame
- up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.