CClinicalTrials.gg
Status unknownNCT05005468CAMFA-LUpdated Aug 13, 2021

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

A Phase 2 interventional study of Camrelizumab and Famitinib in NSCLC, sponsored by Shanghai Chest Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-08-13.

Sponsored by Shanghai Chest Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

Immunotherapy has shown good efficacy in advanced NSCLC. The IMpower010 study has found that immune adjuvant therapy after postoperative chemotherapy can significantly prolong disease-free survival. A number of basic and clinical studies have found that anti-vascular drugs can improve the tumor immune microenvironment, and the combination of anti-vascular and immunotherapy may further improve the efficacy. In this study, postoperative NSCLC with a high risk of recurrence was screened out through ctDNA detection, and received Camrelizumab combined with famitinib or observation to observe the efficacy and safety.

02

Conditions studied

  • NSCLC

Keywords

  • NSCLC
  • II-IIIA
03

In context

Lead sponsor

Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥18 years old and ≤75 years old, both male and female;
  2. 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;
  3. ECOG PS score 0-1 points;
  4. EGFR, ALK gene wild type;
  5. 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%;
  6. The estimated survival time is at least 1 year;
  7. 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;
  8. 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.

Exclusion criteria

Exclusion Criteria:

  1. Have received neoadjuvant chemotherapy, radiotherapy or adjuvant radiotherapy;
  2. There is an unhealed wound or the risk of hemorrhage as judged by the investigator;
  3. Even after drug treatment, hypertension is still poorly controlled (continuous increase in systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg);
  4. Urine routine test indicates urine protein ≥(++), or 24-hour urine protein ≥1.0g;
  5. 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;
  6. 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;
  7. 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;
  8. 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 ;
  9. 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;
  10. 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;
  11. 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.;
  12. 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);
  13. Have received a preventive vaccine or attenuated vaccine within 4 weeks before the first administration;
  14. Those who are known to be allergic to any test drug or its excipients;
  15. Pregnant and lactating patients, and reproductive patients are unwilling to take effective contraceptive measures;
  16. Have a clear history of neurological or mental disorders, including epilepsy and dementia;
  17. Patients who cannot swallow the study drug, such as chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis) and intestinal obstruction and other factors that affect drug intake and absorption;
  18. Other circumstances deemed inappropriate by the investigator.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
61 participants (estimated)

Study arms

  • Experimental
    Camrelizumab Combined With Famitinib

    Drug: Camrelizumab Drug: Famitinib

    Drug: Camrelizumab · Drug: Famitinib

  • No intervention
    Observation

    Observation

Interventions

  • DrugCamrelizumab

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

    Also known as: SHR-1210

  • DrugFamitinib

    Famitinib is administered orally, once a day.

    Also known as: Famitinib Malate Capsules

06

What researchers measure

Primary outcomes

  1. DFS

    Disease free survival

    Time frame: 6-18 months

Secondary outcomes

  1. OS

    Overall survival

    Time frame: 30-48 months

  2. DFS at 2/3/5years

    DFS at 2/3/5years

    Time frame: 2-5 years

07

Study locations

1 site
  • Shanghai Chest Hospital
    Shanghai, Shanghai 200000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05005468
Lead sponsor
Shanghai Chest Hospital
Responsible party
Baohui Han (Head of department, Shanghai Chest Hospital, Shanghai Chest Hospital) — Principal investigator
First posted
Aug 13, 2021
Start date
Sep 2021 (estimated)
Primary completion
Aug 2023 (estimated)
Completion
Aug 2024 (estimated)
Last update
Aug 13, 2021

Study contacts

Baohui Han
Contact
18930858216@163.com
18930858216
Baohui Han
principal investigator · Shanghai Chest Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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