Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04619433
Other study ID # SHR-1210-III-324
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date February 1, 2021
Est. completion date October 15, 2023

Study information

Verified date November 2020
Source Jiangsu HengRui Medicine Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is being conducted to evaluate the efficacy and safety of SHR-1210 in combination with Famitinib plus chemotherapy in subjects with NSCLC.


Description:

The study is being conducted to evaluate the efficacy and safety of Camrelizumab in combination with Famitinib plus chemotherapy in subjects with NSCLC.


Recruitment information / eligibility

Status Recruiting
Enrollment 560
Est. completion date October 15, 2023
Est. primary completion date December 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. Signed Informed Consent Form, male or female, 18-70 years of age. 2. Histologically or cytologically confirmed, Stage IIIB-IV non-squamous NSCLC 3. EGFR mutation and ALK rearrangement status must be negative. 4. No prior system chemotherapy for advanced/metastatic NSCLC. 5. Measurable diseaseas defined by RECIST v1.1. 6. ECOG performance status of 0 or 1. 7. Has a life expectancy of at least 3 months. 8. Adequater organ function. 9. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose, and be willing to use a recognized effective contraceptive measure during the study and within 3 months after the last dose of the study drug; Male subjects with partners of childbearing potential must either be surgically sterilized or agree to take effective contraceptive measures during the study and within 3 months after the last dose of the study drug. Exclusion Criteria: 1? Cancer-Specific Exclusions 1. Other histological types of non-small cell lung cancer. 2. Subjects with carcinomatous meningitis and spinal cord compression. 3. Subjects with untreated central nervous system (CNS) metastasis. 4. Subjects who can be treated with surgical resection or radical radiotherapy. 5. Subjects who previously received anti-PD-1(L1) or CTLA4 monoclonal antibody, VEGF or VEGFR signaling pathway single target/multiple target inhibitor or monoclonal antibodies. 2. Medical history and complications 1. Subjects with any active, known, or suspected autoimmune diseases. 2. Subjects who require systemic corticosteroids prednisone (> 10 mg/day or equivalent) or other immunosuppressants within 14 days prior to the first dose. 3. Subjects who received cancer vaccines or other immunostimulatory anti-cancer agents (interferon, interleukin, thymosin, or immune cell therapy) within 1 month prior to the first dose. 4. Subjects who received anti-cancer TCM within 14 days prior to the first dose. 5. Subjects who are in another clinical study or last participated (last dose) in a clinical study less than 4 weeks (or 5 half-lives of the study drug) from the first dose, whichever is shorter. 6. Subjects who are expected to require other forms of anti-cancer treatment during the study. 7. Subjects who received major surgery within 4 weeks prior to the first dose, non-thoracic radiation therapy > 30 Gy within 4 weeks prior to the first dose, thoracic radiation therapy > 30 Gy within 24 weeks prior to the first dose, or palliative radiation = 30 Gy within 2 weeks prior to the first dose, and failed to recover from the toxicities and/or complications of these interventions to NCI-CTC AE Grade = 1 (except for alopecia and fatigue). Palliative radiotherapy for symptomatic control is permitted, but must be completed within 2 weeks prior to starting the study treatment. 8. Subjects highly suspected of interstitial lung disease, or with conditions that may interfere with the testing or management of suspected treatment-related pulmonary toxicities, or other moderate to severe lung diseases that seriously affect pulmonary function. 9. Subjects with a history of malignant tumors. 10. Subjects with severe cardiovascular disease. 11. Subjectss with hypertension which cannot be well controlled by antihypertensives. 12. Subjects with clinically significant hemorrhage or clear bleeding tendency within 3 month prior to the first dose. 13. Events of arterial/venous thrombosis within 6 months prior to the first dose. 14. Subjects who require long-term anticoagulant therapy with warfarin or heparin. 15. Subjects who require long-term antiplatelet therapy. 16. Significant vascular invasions or a high possibility of significant vascular invasions that may cause bleeding as determined by the investigator during treatment. 17. Subjects with active pulmonary tuberculosis (TB). 18. Subjects with serious infection within 4 weeks prior to the first dose, including but not limited to infective complications, bacteremia, and severe pneumonia that require hospitalization. 19. Subjects who prepare to receive or have previously received tissue/organ transplants. 20. Gastrointestinal disorder or surgical history that may affect the swallowing, digestion, and absorption of the oral drug as determined by the investigator. 21. Subjects who plan to receive or have received live vaccines within 30 days prior to the first dose. 22. Subjects with uncontrolled cancer pain. 3. Physical examination and laboratory tests 1. Known history of human immunodeficiency virus (HIV) seropositive status or acquired immunodeficiency syndrome (AIDS). 2. Active hepatitis B virus or hepatitis C virus infection. 3. Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 4. Allergies and adverse drug reactions 1. Severe allergic reactions to other monoclonal antibodies. 2. Allergy or intolerance during an infusion. 3. History of severe allergies to pemetrexed, carboplatin, or their premedications. 5. Subjects with mental illness, alcohol abuse, inability to quit smoking, and drug or substance abuse. 6. Based on the investigator's judgment, subjects with a history or current evidence of diseases, treatments, or laboratory abnormalities that may affect study results, interfere with study procedures, or are not in the best interests of the subjects, should be excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Camrelizumab;Pemetrexed and Carboplatin; Famitinib;
Part 1: Drug: Camrelizumab; Pemetrexed; Carboplatin; Famitinib Part 2: Drug: Camrelizumab; Pemetrexed; Carboplatin; Famitinib
Camrelizumab;Pemetrexed and Carboplatin;Placebo
Part 2: Drug: Camrelizumab; Pemetrexed; Carboplatin; Placebo

Locations

Country Name City State
China Beijing Cancer Hosipital Beijing Beijing
China Beijing Cancer Hosipital Beijing Beijing
China West China Hospital,Sichuan University Chengdu Sichuan
China Shanghai Lung Hospital Shanghai Shanghai
China Shengjing Hospita of China Medical University Shenyang Liaoning
China Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin
China Hubei Cancer Hospita Wuhan Hubei
China Henan Cancer Hospital Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part 1:Serum concentrations of Camrelizumab Cycle 2; each cycle is 21 days (up to 42 days)
Primary Part 1:Plasma concentrations of Famitinib Cycle 2; each cycle is 21 days (up to 42 days)
Primary Part 1:Area Under the Plasma Concentration Versus Time Curve (AUC) of Famitinib. Cycle 2; each cycle is 21 days (up to 42 days)
Primary Part 1:Maximum Concentration (Cmax) of Famitinib. Cycle 2; each cycle is 21 days (up to 42 days)
Primary Part 1:Time to Maximum Concentration (Tmax) of Famitinib. Cycle 2; each cycle is 21 days (up to 42 days)
Primary Part 1:Half-life (t1/2 z) of Famitinib. Cycle 2; each cycle is 21 days (up to 42 days)
Primary Part 1:Apparent Clearance (CL/F) of Famitinib Cycle 2; each cycle is 21 days (up to 42 days)
Primary Part 1:Vz/F of Famitinib. Cycle 2; each cycle is 21 days (up to 42 days)
Primary Part 2: Progression-free Survival (PFS) as Assessed by BICR according to RECIST 1.1. up to 24 months
Secondary Part 1:Objective Response Rate (ORR) as Assessed by investigators Cycle 2; each cycle is 21 days (up to 42 days)
Secondary Part 1:Duration of Response (DOR) as Assessed by investigators Cycle 2; each cycle is 21 days (up to 42 days)
Secondary Part 1:Progression-free Survival (PFS) as Assessed by investigators Cycle 2; each cycle is 21 days (up to 42 days)
Secondary Part 1:Overall Survival (OS). Up to approximately 60 months
Secondary Part 2:Overall Survival (OS) Up to approximately 60 months
Secondary Part 2:Progression-free Survival (PFS) as Assessed by investigators according to RECIST 1.1. up to 24 months
Secondary Part 2:Objective Response Rate (ORR) as Assessed by investigators and BICR according to RECIST 1.1 up to 24 months
Secondary Part 2:Duration of Response (DOR) as Assessed by investigators and BICR according to RECIST 1.1 up to 24 months
Secondary Part 2:Disease Control Rate(DCR) as Assessed by investigators and BICR according to RECIST 1.1 up to 24 months
Secondary Part 2:Number of Participants With Adverse Events and Serious Adverse Event as Assessed by CTCAE v5.0. up to 24 months
See also
  Status Clinical Trial Phase
Completed NCT04504916 - A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Solid Tumors (MK-2140-002) Phase 2
Not yet recruiting NCT05849246 - The Study of Tusamitamab Ravtansine (IBI126) Combined With Sintilimab and Tusamitamab Ravtansine (IBI126) Combined With Sintilimab Plus Platinum-based Chemotherapy and Pemetrexed in Subjects With CEACAM5 Positive Expression Advanced/Metastatic Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Phase 2
Active, not recruiting NCT04396457 - Pembrolizumab Plus Pemetrexed for Elderly Patients With Non-Sq NSCLC With PD-L1 < 50%: CJLSG1901 Phase 2
Recruiting NCT05338619 - A Study of Lazertinib as Consolidation Therapy in Patients With Locally Advanced, Unresectable, EGFR-Mutant Non-Small Cell Lung Cancer (Stage III) Following Chemoradiation Therapy Phase 2
Terminated NCT04265534 - KEAPSAKE: A Study of Telaglenastat (CB-839) With Standard-of-Care Chemoimmunotherapy in 1L KEAP1/NRF2-Mutated, Nonsquamous NSCLC Phase 2
Active, not recruiting NCT05258279 - Lenvatinib in Combination With Carboplatin Pemetrexed and Pembrolizumab for NSCLC With EGFR Mutations Phase 2
Not yet recruiting NCT04453423 - Combination Chemotherapy With or Without Anlotinib in the Maintenance Treatment of Non-Squamous Non-Small Cell Lung Cancer. Phase 2
Terminated NCT04173338 - Cabozantinib With Pemetrexed in Advanced Non-small Cell Lung Cancer, Urothelial Cancer and Malignant Mesothelioma Phase 1
Terminated NCT04698681 - NGS Screening Protocol to Detect Mutation of KEAP1 or NRF2/NFE2L2 Genes for the KEAPSAKE (CX-839-014) Trial
Active, not recruiting NCT04211090 - Camrelizumab With AC in Patients With Brain Metastases of Driven Gene-negative,NSCLC Phase 2
Recruiting NCT04084717 - Study of Crizotinib for ROS1 and MET Activated Lung Cancer Phase 2
Recruiting NCT04958811 - Tiragolumab With Atezolizumab Plus Bevacizumab in Previously-Treated Advanced Non-squamous NSCLC Phase 2
Completed NCT00152477 - A Study of Paclitaxel/Carboplatin With or Without CDP791 in Patients With Lung Cancer Phase 2
Completed NCT04012619 - Anlotinib Hydrochloride Combined With AP in Stage IIIB/IIIC/IV Non-squamous Non-small-cell Lung Cancer Phase 1
Recruiting NCT05403554 - A Study of NI-1801 in Patients With Mesothelin Expressing Solid Cancers Phase 1
Completed NCT05318443 - A Study Exploring Efficacy of SIBP04 in Subjects With Non-squamous Non-small Cell Lung Cancer Phase 3