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

Efficacy and Safety of Postoperative Adjuvant Chemotherapy Combined With Camrelizumab for Patients With ⅡA -ⅢA Non-small Cell Lung Cancer：a Phase II , Single-arm Clinical Study

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.

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy; Immunotherapy
• Intervention / Treatment: Drug: Camrelizumab

• Study Type: Interventional
• Enrollment (Anticipated): 57
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Di Lu; Phone Number: 020-62787240; Email: david_lu1989@163.com

Study Locations

• China
  • Guangdong
    • Guandong, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: Di Lu, MD, PhD; Phone Number: 86+13268379321; Email: david_lu189@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.; Other Names: Cisplatin; carboplatin; pemetrexed; paclitaxel liposome; albumen-paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Three-years disease free survival (3y-DFS)	According to the K-M curve, the proportion of disease-free progression in 3 years	Up to approximately 3 years
Five-years disease free survival (5y-DFS)	According to the K-M curve, the proportion of disease-free progression in 5 years	Up to approximately 5 years
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.	Up to approximately 2 years
Overall survival (OS)	Defined as the time from randomization to death from any cause.	Up to approximately 5 years
Two-years overall survival（2y-OS)	According to the K-M curve, the proportion of OS in 2 years	Up to approximately 2 years
Three-years overall survival（3y-OS)	According to the K-M curve, the proportion of OS in 3 years	Up to approximately 3 years
Five-years overall survival（5y-OS)	According to the K-M curve, the proportion of OS in 5 years	Up to approximately 5 years
Treatment-related adverse events（TRAE）	The incidence of TRAE and the incidence of level 3-4 TRAE according to CTCAE v5.0	Up to approximately 1 year

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Jiangsu Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Anticipated): April 1, 2026
• Study Completion (Anticipated): April 1, 2029

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 22, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Non-small Cell Lung Cancer; Camrelizumab; Adjuvant therapy
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Folic Acid Antagonists; Carboplatin; Paclitaxel; Cisplatin; Albumin-Bound Paclitaxel; Pemetrexed
• Other Study ID Numbers: NFEC-2023-031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No