A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer

Phase 3

Recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: pembrolizumab; Drug: camrelizumab + famitinib; Drug: camrelizumab

• Registration Number: NCT05042375
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

The study is being conducted to evaluate the efficacy, and safety of camrelizumab combined with famitinib malate vs. pembrolizumab in treatment naïve subjects with programmed death-ligand 1(PD-L1)-positive recurrent or metastatic non-small cell lung cancer (NSCLC).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-01
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-13
• Study Start: 2022-09-08
• Status Verified: 2022-10
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-17
• Primary Completion: 2023-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1. Have a histologically or cytologically confirmed diagnosis of metastatic NSCLC (stage IV according to the TNM staging criteria [8th edition] published by the International Association for the Study of Lung Cancer [IASLC]), or NSCLC that recurs after curable surgery, radiotherapy, or radiochemotherapy.
2. Have measurable disease based on RECIST v1.1.
3. ECOG PS score: 0-1.
4. Have a life expectancy of at least 3 months.
5. 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 within 6 months after the last dose of study drugs.
6. Have voluntarily agreed to participate by giving written informed consent for the study, have good compliance, and cooperate with follow-up visits.

Exclusion Criteria

1. Accompanied with EGFR activating mutation, ALK fusion gene positive or ROS1 mutation.
2. Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites.
3. Have known history of prior malignancy in the past 3 years.
4. Have had an allogeneic tissue/solid organ transplant.
5. Have active pulmonary tuberculosis.
6. Have clinical symptoms of the heart or heart diseases that are not well controlled.
7. Have hypertension which cannot be well controlled by antihypertensives
8. 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.
9. Have a thrombosis tendency or are currently receiving thrombolysis/anticoagulation therapy.
10. 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.
11. Have known history of arterial/venous thrombosis within 6 months prior to randomization, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism.
12. Have received prior therapy with anti-PD-1/PD-L1 monoclonal antibodies, anti-CTLA-4 monoclonal antibodies, or small molecule VEGFR inhibitors.
13. Have known allergies to other monoclonal antibodies or any component of famitinib.
14. 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.
15. Have other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, substance abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of medication.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pembrolizumab	pembrolizumab	-
camrelizumab + famitinib	camrelizumab + famitinib	-
camrelizumab	camrelizumab	-

Primary Outcome Measures

Name	Time	Method
PFS assessed by BIRC	up to 3 years	Progression-Free-Survival, defined as the time from randomization to the first occurrence of disease progression as determined by IRC with use of RECIST v1.1 or death from any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
DCR	up to 3 years	Disease Control Rate, determined using RECIST v1.1 criteria
DoR	up to 3 years	Duration of Response, determined using RECIST v1.1 criteria
TTF	up to 3 years	Time to Treatment Failure, defined as the time from randomization to treatment discontinuation.
AEs+SAEs	from the first drug administration to within 90 days for the last SHR-1210 dose	Adverse Events and Serious Adverse Events
ORR	up to 3 years	Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (CR or PR) across all assessment time points
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
PFS assessed by investigator	up to 3 years	Progression-Free-Survival

Trial Locations

Locations (80)

The First Affiliated Hospital of Bengbu Medical College; 🇨🇳 Bengbu, Anhui, China

Anhui Chest Hospital; 🇨🇳 Hefei, Anhui, China

Anhui Provincial Cancer Hospital; 🇨🇳 Hefei, Anhui, China

Anhui Provincial Hospital; 🇨🇳 Hefei, Anhui, China

The First Affiliated Hospital Of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Chest Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

ChongQing University Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China

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