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UNKNOWNPHASE3

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

A Randomized, Open-Label, Controlled, Multi-center Phase Ⅲ Study of Camrelizumab Combined With Famitinib Malate Versus Pembrolizumab in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer

NCT05042375•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+5 more criteria

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 Municipality, China

Beijing Chest Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

ChongQing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Key Dates

Start Date

September 8, 2022

Primary Completion Date

December 31, 2023

Completion Date

December 31, 2025

Last Updated

November 17, 2022

Enrollment

450

ESTIMATED participants

Conditions

Non-small Cell Lung Cancer

Interventions

camrelizumab + famitinib

DRUG

pembrolizumab

DRUG

camrelizumab

DRUG

Contacts

weixia Li, M.M

CONTACT

+86-15005136260 Weixia.li@hengrui.com

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

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