Pd-1 monoclonal antibody SHR-1210 combined with irinotecan versus irinotecan for the second-line treatment of extensive small-cell lung cancer in a multicenter, randomized, controlled clinical study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900027139

Enrollment

Unknown

Registered

2019-11-01

Start date

2019-12-01

Completion date

Unknown

Last updated

2019-11-04

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

Conditions

Lung cancer

Interventions

Experimental group:SHR-1210 + Irinotecan

Control group:Irinotecan

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years, no restriction on gender; 2. Patients with extensive small-cell lung cancer diagnosed by histopathology; 3. Second-line treatment: imaging progress after first-line standard platinum-based chemotherapy; 4. ECOG PS: 0-1; 5. At least one CT/MRI measurable lesion; 6. Expected survival at least 3 months; 7. Peripheral blood imaging, liver and renal function should be within the following allowed range (detected within 7 days before the start of treatment): -- WBC =3.0×109/L or ANC =1.5×109/L; -- HGB =80 g/L; -- PLT =100×109/L; -- AST, ALT < 5.0 × ULN; -- TBIL < 2 ×ULN; -- CREAT < 1.5 ×ULN; 8. Patients of childbearing age must take effective birth control measures; 9. Sign informed consent. Those who meet all of the criteria above will be included in the study.

Exclusion criteria

Exclusion criteria: 1. Patients having other tumors; 2. Previous exposure to therapeutic anticancer vaccines or T cell co-stimulation therapy or immune checkpoint inhibitors, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-PD-L2 antibodies; 3. Participated in clinical trials of other drugs within 4 weeks before the study begin; 4. Those who are known to be allergic to the drug ingredients involved in the study; 5. Had a history of other malignant tumors in the previous 5 years, except cured basal cell carcinoma of the skin and cervical carcinoma in situ; 6. Pregnant or lactating women; 7. Having serious or uncontrolled infections; 8. Drug abuse, drug abuse, long-term alcohol abuse and positive test for hepatitis b virus or HIV; Those who meet any of the criteria above will not be included in the study.

Design outcomes

Primary

Measure	Time frame
OS;	—

Secondary

Measure	Time frame
ORR;DCR;PFS;QOL;	—

Countries

China

Contacts

Public ContactJian Zhang

blacktiger@139.com+86 13925091863

Outcome results

None listed

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