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NCT Number: NCT05825443

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

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nanfang Hospital, Southern Medical University

Guandong, Guangdong, 510515, China

Location status: Recruiting

Location contact

Di Lu, MD, PhD

CONTACT

[email protected]

86+13268379321

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • 18-80 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.

Exclusion criteria

  • 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;
  • Any disease that is unstable or may endanger the patient's safety;
  • Drug abuse, medical, psychological or social diseases;
  • Participate in other clinical studies within 3 months before enrollment;
  • During pregnancy or lactation;

Treatment and study plan

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.

Other names: Cisplatin, carboplatin, pemetrexed, paclitaxel liposome, albumen-paclitaxel

Primary outcomes

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

    Time frame: Up to approximately 2 years

    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.

Secondary outcomes

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

    Time frame: Up to approximately 3 years

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

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

    Time frame: Up to approximately 5 years

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

  3. Disease free survival (DFS)

    Time frame: Up to approximately 2 years

    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.

  4. Overall survival (OS)

    Time frame: Up to approximately 5 years

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

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

    Time frame: Up to approximately 2 years

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

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

    Time frame: Up to approximately 3 years

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

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

    Time frame: Up to approximately 5 years

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

  8. Treatment-related adverse events(TRAE)

    Time frame: Up to approximately 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • Jiangsu Hengrui Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Acronym: PANORAMA

Important dates

Study start
2023
Primary completion
2026
Study completion
2029
First posted
Apr 24, 2023
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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