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

Phase 3

Terminated

• Conditions: Advanced NSCLC
• Interventions: Drug: camrelizumab + famitinib; Drug: docetaxel; Drug: famitinib

• Registration Number: NCT05106335
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-22
• Study First Submitted QC: 2021-10-22
• Study First Posted: 2021-11-03
• Study Start: 2022-01-06
• Primary Completion: 2022-05-11
• Study Completion: 2022-05-11
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-14
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm A	camrelizumab + famitinib	camrelizumab + famitinib
Treatment Arm B	docetaxel	docetaxel
Treatment Arm C	famitinib	famitinib

Primary Outcome Measures

Name	Time	Method
OS	up to 4 years	OS is the time interval from the date of randomization to death due to any reason or lost of follow-up.

Secondary Outcome Measures

Name	Time	Method
TTF	up to 4 years	Time to Treatment Failure, defined as the time from randomization to treatment discontinuation.
PFS	up to 4 years	Progression-Free-Survival, defined as the time from randomization to the first occurrence of disease progression with use of RECIST v1.1 or death from any cause, whichever occurs first.
ORR	up to 4 years	Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (CR or PR) across all assessment time points.
DoR	up to 4 years	Duration of Response, determined using RECIST v1.1 criteria.
DCR	up to 4 years	Disease Control Rate, determined using RECIST v1.1 criteria.

Trial Locations

Locations (1)

Subei People's Hospital of Jiangsu Province; 🇨🇳 Yangzhou, Jiangsu, China