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

NCT05825443 | Recruiting Phase 2

• 1 other identifier: NFEC-2023-031
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immunotherapy; Chemotherapy

Keywords

Camrelizumab; Non-small Cell Lung Cancer; Adjuvant therapy

Outcome Measures

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.

  Up to approximately 2 years

Secondary Outcomes (8)

• Three-years disease free survival (3y-DFS)

  Up to approximately 3 years

• Five-years disease free survival (5y-DFS)

  Up to approximately 5 years

• Disease free survival (DFS）

  Up to approximately 2 years

• Overall survival (OS)

  Up to approximately 5 years

• Two-years overall survival（2y-OS)

  Up to approximately 2 years

Study Arms (1)

Treatment group

EXPERIMENTAL

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

Camrelizumab DRUG

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

Treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent form before starting the study;
• For patients with non-small cell lung cancer who have undergone surgical resection, the TNM stage after surgery is IIA-IIIA;
• Patients cannot receive targeted adjuvant therapy;
• years old;
• The patient can recover within 3-8 weeks after the operation, and receive postoperative adjuvant treatment;
• The ECOG PS score is 0 or 1;
• Have not received any chemotherapy for non-small cell lung cancer before enrollment;
• 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;
• Female patients must meet: menopause or have undergone surgical sterilization. Women with fertility must take effective contraceptive measures. Do not breastfeed.
• Male patients must agree to use appropriate contraceptive measures.

You may not qualify if:

• Known or suspected to be allergic to the drug or any component of the drug related to the test;
• Patients who can receive targeted treatment;
• 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;
• 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;
• Uncontrolled hypertension after treatment with antihypertensive drugs, i.e. systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg;
• History of HIV infection, active period of HCV infection, active period of HBV infection (HBV-DNA\>1000 copies/ml);
• The researcher judged that there was a risk of bleeding;
• Active severe clinical infection (≥ grade 3 CTCAE V5.0);
• Epilepsy patients who need medication;
• Allogeneic organ transplantation;
• Patients who need kidney dialysis;
• Thrombotic or embolic venous or arterial events occurred within six months before enrollment;
• Serious uncured wounds, ulcers or fractures;
• Interstitial pneumonia;
• Any malabsorption disease;

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Jiangsu Hengrui Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guandong, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

camrelizumab; Cisplatin; Carboplatin; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Central Study Contacts

Di Lu

CONTACT

020-62787240; david_lu1989@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Four cycles of chemotherapy combine with camrelizumab, followed by maintenance with camrelizumab until one year or the disease progressed or unacceptable toxicity

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: April 24, 2023
• Study Start: April 10, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)