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RecruitingNCT05825443PANORAMAUpdated Apr 25, 2023

Adjuvant Chemotherapy Combined With Camrelizumab for ⅡA -ⅢA NSCLC Patients

A Phase 2 interventional study of Camrelizumab in Immunotherapy and Chemotherapy, sponsored by Nanfang Hospital, Southern Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-04-25.

Sponsored by Nanfang Hospital, Southern Medical University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 5 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
57
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Postoperative adjuvant chemotherapy followed by immunotherapy for non-small cell lung cancer has become a new treatment recommendation, but there are still many clinical problems to be solved in postoperative adjuvant immunotherapy. This study aims to explore the efficacy and safety of adjuvant chemotherapy combined with immunotherapy in patients with stage IIA-IIIA non-small cell lung cancer after surgery. Patients who meet the protocol and sign the informed consent form received 4 cycles of chemotherapy combined with camrelizumab, followed by maintenance with camrelizumab until one year or the disease progressed or unacceptable toxicity.

02

Conditions studied

  • Immunotherapy
  • Chemotherapy

Keywords

  • Camrelizumab
  • Non-small Cell Lung Cancer
  • Adjuvant therapy
03

In context

Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Sign the informed consent form before starting the study;
  2. For patients with non-small cell lung cancer who have undergone surgical resection, the TNM stage after surgery is IIA-IIIA;
  3. Patients cannot receive targeted adjuvant therapy;
  4. 18-80 years old;
  5. The patient can recover within 3-8 weeks after the operation, and receive postoperative adjuvant treatment;
  6. The ECOG PS score is 0 or 1;
  7. Have not received any chemotherapy for non-small cell lung cancer before enrollment;

  8. Within 7 days before enrollment, the laboratory inspection must meet all the following requirements:

    • Absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 9g/dL;
    • Total bilirubin ≤ 1.5 ULN; AST and ALT ≤ 2.5 ULN;
    • Serum creatinine ≤ 1.25 ULN, or serum creatinine clearance ≥ 60ml/min;
  9. Female patients must meet: menopause or have undergone surgical sterilization. Women with fertility must take effective contraceptive measures. Do not breastfeed.
  10. Male patients must agree to use appropriate contraceptive measures.

Exclusion criteria

Exclusion Criteria:

  1. Known or suspected to be allergic to the drug or any component of the drug related to the test;
  2. Patients who can receive targeted treatment;
  3. Other malignant tumors in five years before enrollment, excluding the cured cervical carcinoma in situ, the cured skin basal cell carcinoma, and other types of tumors that were cured only after surgical treatment;
  4. Myocardial infarction, unstable angina pectoris and grade II congestive heart failure in six months before enrollment; New angina pectoris occurred within 3 months; Ventricular arrhythmia requiring medication;
  5. Uncontrolled hypertension after treatment with antihypertensive drugs, i.e. systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg;
  6. History of HIV infection, active period of HCV infection, active period of HBV infection (HBV-DNA>1000 copies/ml);
  7. The researcher judged that there was a risk of bleeding;
  8. Active severe clinical infection (≥ grade 3 CTCAE V5.0);
  9. Epilepsy patients who need medication;
  10. Allogeneic organ transplantation;
  11. Patients who need kidney dialysis;
  12. Thrombotic or embolic venous or arterial events occurred within six months before enrollment;
  13. Serious uncured wounds, ulcers or fractures;
  14. Interstitial pneumonia;
  15. Any malabsorption disease;
  16. Any disease that is unstable or may endanger the patient's safety;
  17. Drug abuse, medical, psychological or social diseases;
  18. Participate in other clinical studies within 3 months before enrollment;
  19. During pregnancy or lactation;
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
57 participants (estimated)

Study arms

  • Experimental
    Treatment group

    Patients who meet the protocol and sign the informed consent form received 4 cycles of chemotherapy combined with camrelizumab, followed by maintenance with camrelizumab until one year or the disease progressed or unacceptable toxicity. The chemotherapy regimen is decided by the researcher.

    Drug: Camrelizumab

Interventions

  • DrugCamrelizumab

    Patients received four 21-day cycles of chemotherapy (decided by the researcher) combined with camrelizumab (200 mg in day 1), followed by maintenance with camrelizumab (200 mg in day 1, q3w), until one year or the disease progressed or unacceptable toxicity.

    Also known as: Cisplatin, carboplatin, pemetrexed, paclitaxel liposome, albumen-paclitaxel

06

What researchers measure

Primary outcomes

  1. Two-years disease free survival (2y-DFS)

    DFS, defined as the time from first dose of Camrelizumab to the first occurrence of disease recurrence as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. According to the K-M curve, the proportion of disease-free progression in 2 years.

    Time frame: Up to approximately 2 years

Secondary outcomes

  1. Three-years disease free survival (3y-DFS)

    According to the K-M curve, the proportion of disease-free progression in 3 years

    Time frame: Up to approximately 3 years

  2. Five-years disease free survival (5y-DFS)

    According to the K-M curve, the proportion of disease-free progression in 5 years

    Time frame: Up to approximately 5 years

  3. Disease free survival (DFS）

    DFS, defined as the time from first dose of Camrelizumab to the first occurrence of disease recurrence as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.

    Time frame: Up to approximately 2 years

  4. Overall survival (OS)

    Defined as the time from randomization to death from any cause.

    Time frame: Up to approximately 5 years

  5. Two-years overall survival（2y-OS)

    According to the K-M curve, the proportion of OS in 2 years

    Time frame: Up to approximately 2 years

  6. Three-years overall survival（3y-OS)

    According to the K-M curve, the proportion of OS in 3 years

    Time frame: Up to approximately 3 years

  7. Five-years overall survival（5y-OS)

    According to the K-M curve, the proportion of OS in 5 years

    Time frame: Up to approximately 5 years

  8. Treatment-related adverse events（TRAE）

    The incidence of TRAE and the incidence of level 3-4 TRAE according to CTCAE v5.0

    Time frame: Up to approximately 1 year

07

Study locations

1 of 1 sites recruiting
  • Nanfang Hospital, Southern Medical University
    Guandong, Guangdong 510515, China
    Recruiting
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 Apr 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05825443
Lead sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Apr 24, 2023
Start date
Apr 10, 2023
Primary completion
Apr 1, 2026 (estimated)
Completion
Apr 1, 2029 (estimated)
Last update
Apr 25, 2023

Study contacts

Di Lu
Contact
david_lu1989@163.com
020-62787240

Oversight

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

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