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PD-1 inhibitor plus chemotherapy and VEGFR inhibitor or placebo in advanced non-squamous NSCLC patients: a randomized, controlled, multicenter, phase III study

PD-1 inhibitor plus chemotherapy and VEGFR inhibitor or placebo in advanced non-squamous NSCLC patients: a randomized, controlled, multicenter, phase III study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037269
Enrollment
Unknown
Registered
2020-08-27
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-13

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:camrelizumab+famitinib+pemetrexed+carboplatin
control group:camrelizum+pemetrexed+carboplatin

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years; 2. Advanced (IV phase)non squamous NSCLC confirmed by pathology, with measurable lesions (tumour lesions >= 10mm in longest diameter, malignant lymph nodes >= 15mm in short axis, scanning layer = 90g/L ( no blood transfusion in 2 weeks); 2) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; 3) PLT >= 80 x 10^9/L; 4) Bilirubin 45 ml/min(Cockcroft-Gault Formula); 8) cholesterol = LLN by Color Doppler Ultrasonography. 7. Female: Child bearing potential, a negative urine or serum pregnancy test result 7 days before initiating famitinib.All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 3 months after the last dose of test article. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 3 months after the last dose of test article; 8. Ability to understand and willingness to sign a written informed consent. Good compliance with follow-up visits.

Exclusion criteria

Exclusion criteria: 1. Squamous cell carcinoma (including adenosquamous carcinoma, undifferentiated carcinoma); small cell lung cancer; 2. EGFR mutation or ALK fusion positive subjects; 3. without measurable lesions. 4. with cancerous meningitis, spinal cord compression, etc.; 5. with untreated central nervous system (CNS) tumor metastases. If the subject's CNS tumor metastasis is limited to the supratentorial and/or cerebellum and has received adequate treatment, such as clinical stability (imaging testing, enhanced MRI or CT is preferred) has been maintained for at least 4 weeks, and the subject's nervous system If the clinical symptoms can be restored to NCI-CTC AE <=1 degree at least 2 weeks before the first medication, you can participate in the study. In addition, if subjects use corticosteroids to treat related clinical symptoms, they should receive a stable or gradually decreasing dose of prednisone (or equivalent) of <=10 mg/day for at least 2 weeks before participating in the study, otherwise they cannot be included in the group; 6. Subjects who can be surgically removed or treated with radical radiotherapy; 7. Subjects who have received PD-1/PD-L antibody or VEGF inhibitor.

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Secondary

MeasureTime frame
overall-survival;objective response rate;

Countries

China

Contacts

Public ContactCaicun Zhou

Shanghai Pulmonary Hospital

caicunzhoudr@163.com+86 13301825532

Outcome results

None listed

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