A Study to Evaluate Camrelizumab Combined With Famitinib as Subsequent Therapy in Patients With Advanced NSCLC

Hengrui Medicine

Status and phase: Terminated; Phase 3

Conditions: Advanced NSCLC

Treatments: Drug: docetaxel; Drug: camrelizumab + famitinib; Drug: famitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05106335

SHR-1210-III-332

Details and patient eligibility

About

This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy, and safety of camrelizumab combined with famitinib malate versus docetaxel as subsequent therapy in Advanced NSCLC.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically or cytologically confirmed metastatic or recurrent non-small cell lung cancer.
2. Failed previous platinum-based chemotherapy and anti-PD-(L)1 monoclonal antibody treatment.
3. Have measurable disease based on RECIST v1.1.
4. ECOG PS score: 0-1.
5. Expected survival ≥ 3 months.
6. Non-surgically sterilized female subjects or women of childbearing potential must be negative for a serum pregnancy test within 3 days prior to the first dose and must be non-lactating. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to take highly effective contraceptive measures during the study period and until 6 months after the last study dose.
7. Subjects must participate voluntarily, sign the ICF, have good compliance, and cooperate with follow-up visits.

Exclusion criteria

1. Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites.
2. Have known history of prior malignancy in the past 3 years.
3. Have active pulmonary tuberculosis.
4. Have clinical symptoms of the heart or heart diseases that are not well controlled.
5. Have hypertension which cannot be well controlled by antihypertensives
6. Urinalysis has indicated that the urine protein is ≥ ++ and quantitative test of urine protein has confirmed that the 24-h urine protein is > 1.0 g.
7. Have a thrombosis tendency or are currently receiving thrombolysis/anticoagulation therapy.
8. Have received major surgery within 4 weeks prior to randomization; or palliative radiotherapy within 2 weeks prior to randomization; or have not recovered from the toxicities and/or complications of previous interventions to NCI-CTCAE Grade ≤ 1.
9. Have known history of arterial/venous thrombosis within 6 months prior to randomization, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism.
10. Are currently participating and receiving study therapy or have participated in a study and received the last dose of study drug within 4 weeks (or 5 half-lives of the study drug) prior to randomization.
11. Previous treatment with camrelizumab, docetaxel, and small-molecule VEGFR inhibitors including famitinib.
12. Have other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 3 patient groups

Treatment Arm A

Experimental group

Description:

camrelizumab + famitinib

Treatment:

Drug: camrelizumab + famitinib

Treatment Arm C

Experimental group

Description:

famitinib

Treatment:

Drug: famitinib

Treatment Arm B

Active Comparator group

Description:

docetaxel

Treatment:

Drug: docetaxel