Clinical trial · Interventional
A Trial of SHR-1701 in Combination With and Without Famitinib Malate in Patients With Extensive Stage Small Cell Lung Cancer
An Open-label, Multicenter PhaseⅡ Study of SHR-1701 in Combination With or Without Famitinib Malate for the Treatment of Extensive Stage Small Cell Lung Cancer After Previous Systemic Chemotherapy Failure
NCT04884009CI-TRIAL-00051746unknownPhase 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)
The study is being conducted to evaluate the efficacy and safety of SHR-1701 in combination with or without famitinib malate for the treatment of extensive stage small cell lung cancer after the failure of previous systemic chemotherapy
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-1701 | Drug | — | UNRESOLVED |
| SHR-1701; Famitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SHR-1701+ Famitinib
- interventionNames
- Drug: SHR-1701; Famitinib
- type
- EXPERIMENTAL
- label
- SHR-1701
- interventionNames
- Drug: SHR-1701
Primary outcomes (1)
- measure
- Objective response rate (ORR) based on RECIST 1.1 criteria
- timeFrame
- up to approximately 1 year.
Secondary outcomes (5)
- measure
- Progression free survival (PFS) based on RECIST 1.1 criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients voluntarily participated in the clinical study, understood the study procedures and are able to sign the informed consent form. 2. 18 to 75 years old, male or female. 3. Histologically or cytologically confirmed extensive stage small cell lung cancer(ED-SCLC). 4. ECOG Performance Status of 0 or 1. 5. Adequate hematological, hepatic and renal function. 6. Female subjects of child-bearing potential must have a negative serum HCG test before treatment. Exclusion Criteria: 1. Histologically or cytologically confirmed mixed SCLC and NSCLC. 2. Untreated central nervous system metastases. 3. Cancerous meningitis (meningeal metastasis). 4. Uncontrolled pleural effusion, pericardial effusion or ascites. 5. Tumor infiltration into the great vessels on imaging; 6. Hemoptysis symptoms and maximum daily hemoptysis ≥ 2.5ml occurred within 1 month. 7. Uncontrolled tumor-related pain. 8. Malignancies other than SCLC within 5 years. 9. Systemic antitumor therapy was received 4 weeks prior to trial treatment. 10. History of autoimmune diseases. 11. Significant cardiovascular disease. 12. Inadequately controlled hypertension. 13. Known history of testing positive test for HIV or known AIDS. 14. Patients with active hepatitis B or hepatitis C 15. Severe infections within 4 weeks prior to trial treatment. 16. Active tuberculosis.
References
Publications (0)
Data not yet available
No reference posted for this study.