A Phase II Trial of Camrelizumab Combined With Famitinib for Adjuvant Treatment of Stage II-IIIA NSCLC.

NCT05005468 | Unknown Phase 2

• 1 other identifier: NSCLC-ADJ-IIT-SHR1210-FMTN
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II, open-label, multi-cohort study, aiming to investigate safety and efficacy of Camrelizumab combined with famitinib for adjuvant treatment of stage II-IIIA non-small cell lung cancer with high-risk for relapse and no driver gene mutation.

Conditions

NSCLC

Keywords

NSCLC; II-IIIA

Outcome Measures

Primary Outcomes (1)

• DFS

  Disease free survival

  6-18 months

Secondary Outcomes (2)

• OS

  30-48 months

• DFS at 2/3/5years

  2-5 years

Study Arms (2)

Camrelizumab Combined With Famitinib

EXPERIMENTAL

Drug: Camrelizumab Drug: Famitinib

Drug: Camrelizumab; Drug: Famitinib

Observation

NO INTERVENTION

Observation

Interventions

Camrelizumab DRUG

Camrelizumab is given on the first day of each cycle, intravenous drip.

Also known as: SHR-1210

Camrelizumab Combined With Famitinib

Famitinib DRUG

Famitinib is administered orally, once a day.

Also known as: Famitinib Malate Capsules

Camrelizumab Combined With Famitinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old and ≤75 years old, both male and female;
• Standard surgical R0 resection and pathologically confirmed patients with stage II-IIIA (UICC/AJCC 7th edition lung cancer TNM staging) non-small cell lung cancer;
• ECOG PS score 0-1 points;
• EGFR, ALK gene wild type;
• The function of major organs is normal, the following standards are met: a) Routine blood examination (under 14 days without blood transfusion and no hematopoietic stimulating factor drugs for correction): hemoglobin (Hb) ≥90g/L; absolute neutrophil count (ANC) ≥1.5×10\^9/L; platelet (PLT) ≥100×10\^9/L; white blood cell count (WBC) ≥3.0×10\^9/L; b) Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN); serum total bilirubin (TBIL) ≤1.5×ULN; serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥50ml/min; c) coagulation function: activated partial coagulation activity Enzyme time (APTT), international normalized ratio (INR), prothrombin time (PT)≤1.5×ULN; d) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF)≥50%;
• The estimated survival time is at least 1 year;
• Women of childbearing age must undergo a negative pregnancy test (serum or urine) within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug; for men, it should be Surgical sterilization or consent to use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug;
• The patient voluntarily participates and signs an informed consent form (or signed by a legal representative). It is expected to have good compliance and be able to cooperate with the research according to the requirements of the plan.

You may not qualify if:

• Have received neoadjuvant chemotherapy, radiotherapy or adjuvant radiotherapy;
• There is an unhealed wound or the risk of hemorrhage as judged by the investigator;
• Even after drug treatment, hypertension is still poorly controlled (continuous increase in systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg);
• Urine routine test indicates urine protein ≥(++), or 24-hour urine protein ≥1.0g;
• Abnormal blood coagulation function (INR\>2.0, PT\>16s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, and allow preventive use of low-dose aspirin and low molecular heparin;
• Patients at risk of gastrointestinal bleeding, including the following conditions: There are active peptic ulcer lesions and stool occult blood (++ \~ +++); Those who have a history of melena and hematemesis within 3 months; For fecal occult blood (+) or (+/-), it is necessary to review the stool routine within 1 week. Those who still (+) or (+/-) must undergo gastroscopy. If there is ulcer, bleeding disease, and The treating physician believes that there is a potential risk of bleeding;
• Suffer from uncontrolled cardiac clinical symptoms or diseases, such as (1) NYHA II and above heart failure; (2) Unstable angina; (3) Myocardial infarction within 1 year; (4) Clinical significance Patients with supraventricular or ventricular arrhythmia requiring clinical intervention;
• Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen \[HBsAg\] test results are positive, HBV-DNA ≥ 500 IU/ml and abnormal liver function; hepatitis C is defined as hepatitis C antibody \[HCV-Ab\] positive, HCV-RNA higher than the detection limit of the analysis method and abnormal liver function) or combined hepatitis B and C co-infection ；
• Suffer from any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormone replacement) Can be included after treatment)); patients with childhood asthma that have been completely relieved and do not require any intervention or vitiligo after adulthood can be included, but patients who require medical intervention with bronchodilators cannot be included;
• Severe infection (such as intravenous infusion of antibiotics, antifungal or antiviral drugs required) within 2 weeks before the first administration, or unexplained fever \>38.5°C during the screening period/before the first administration;
• Arterial/venous thrombosis events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.;
• Suffered from or accompanied with other systemic malignancies in the last 5 years, (except for cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian cancer);
• Have received a preventive vaccine or attenuated vaccine within 4 weeks before the first administration;
• Those who are known to be allergic to any test drug or its excipients;
• Pregnant and lactating patients, and reproductive patients are unwilling to take effective contraceptive measures;

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Interventions

camrelizumab; famitinib

Study Officials

• Baohui Han

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Baohui Han

CONTACT

18930858216; 18930858216@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department, Shanghai Chest Hospital

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 13, 2021
• Study Start: September 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: August 13, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)