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An Exploratory study of SHR-1316 combined with famitinib in the treatment of small cell lung cancer with third-line and above

An Exploratory study of SHR-1316 combined with famitinib in the treatment of small cell lung cancer with third-line and above

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052533
Enrollment
Unknown
Registered
2021-10-30
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small cell lung cancer

Interventions

experimental group:SHR-1316+Famitinib

Sponsors

Chinese Academy of Medical Sciences Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18 to 80 years, no gender limit; 2. Patients with extensive-stage SCLC confirmed by histopathology or cytology; 3. Previously received second-line systemic chemotherapy failed or were intolerant to second-line system chemotherapy; 4. ECOG score: 0-1 points; 5. Expected survival time >= 3 months; 6. The investigator confirmed that there is at least one measurable lesion according to the RECIST1.1 standard; 7. The main organs are functioning normally.

Exclusion criteria

Exclusion criteria: 1. There are central tumors that invade local large blood vessels, there are obvious cavitation or necrotic tumors in the lungs; 2. Active central nervous system tumor metastasis; 3. Known to be allergic to the research drug or any of its excipients; or have a severe allergic reaction to other monoclonal antibodies; 4. Receive live attenuated vaccines within 4 weeks before the first dose or plan to receive live attenuated vaccines during the study period; 5. Immune suppressive drugs have been used within 14 days before the first use of SHR-1316; 6. There is any active autoimmune disease or a history of autoimmune disease; 7. Suffer from myocardial ischemia or myocardial infarction above grade II, or poorly controlled arrhythmia; 8. Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders; 9. Have received major surgery within 4 weeks before the first dose; 10. Other situations that the researcher judges are not suitable for participating in this research.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Progression Free Survival;Overall Survival;Disease Control Rate;Duration of remission;

Countries

China

Contacts

Public ContactLiu Yutao

Chinese Academy of Medical Sciences Cancer Hospital

13911901165@139.com+86 13911901165

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026