Neoadjuvant PD-1 Antibody Plus Apatinib or Chemotherapy for Non-small Cell Lung Cancer

STATUS

Recruiting
End date

Dec 30, 2026
participants needed

99
sponsor

Shanghai Pulmonary Hospital, Shanghai, China

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Updated on 19 February 2024

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blood transfusion

platelet count

measurable disease

metastasis

platinum-based chemotherapy

neutrophil count

anticoagulation therapy

anticoagulants

pulmonary function test

aptt

ros1

pd-1 inhibitor

angiogenesis inhibitor

apatinib

proto-oncogene tyrosine-protein kinase ros

kidney function test

endobronchial ultrasound

cancer immunotherapy

camrelizumab

blockade

oral contraceptives

small cell lung cancer

Summary

Show definitions

Immunotherapy with anti-programmed death 1 (PD-1) antibodies has revolutionized the treatment of metastatic and advanced NSCLC, but its application in neoadjuvant setting has not been well established. Results from a pilot clinical study reported the safety and feasibility of neoadjuvant PD-1 blockade. There are several neoadjuvant immunotherapy (NEOSTAR, LCMC3, NADIM, IMpower131) ongoing, and the preliminary results are reported in 2019 American Society of Clinical Oncology, which show promising therapeutic prospect. However, the therapeutic response rate (major pathologic response [MPR]) are not so good (20% - 45%) for PD-1 inhibitor monotherapy. To improve the therapeutic response, the investigators design a multiple-canter, open-label, phase II trial for stage II-IIIA resectable NSCLC. The participants will receive neoadjuvant PD-1 inhibitor (camrelizumab) combined with antiangiogenic drug (apatinib) or platinum-based chemotherapy.

Description

Detailed Description:

This is a multiple-canter, open-label, phase II trial, 2-4 cycles treatment will be planned as neo-adjuvant therapy for NSCLC participants in stage II-IIIA.

Study design:

Participants: Newly diagnosed Resectable II-IIIA NSCLC without EGFR/ALK/ROS1/BRAF mutation.

Treatment

Group Acamrelizumab 200 mg q3w i.v. for 2-4 cycles, apatinib 250mg pd po 3w/cycle for 2-4 cycles before surgery; Group Bcamrelizumab 200 mg q3w i.v. for 2-4 cycles, platinum-based chemotherapy q3w i.v for 2-4 cycles before surgery.

Endpoints

Primary objectives are to assess MPR and safety. Secondary objective is to assess 2-year overall survival (OS), disease-free survival (DFS), OS etc.

Exploratory end point is to explore biomarkers.

Details

Condition	Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer
Age	18years - 75years
Treatment	Camrelizumab
Clinical Study Identifier	NCT04379739
Sponsor	Shanghai Pulmonary Hospital, Shanghai, China
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Aged 18-75 years
	Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1
	Histological or cytological diagnosis of NSCLC by needle biopsy, and clinical stage II-IIIA (N2 single lymph node station) according to the TNM classification (8th edition) validated by radiological examination or EBUS
	Without EGFR, ALK, ROS1 or BRAF gene mutation
	At least 1 measurable lesion according to RECIST 1.1
	Life expectancy is at least 12 weeks
	Adequate hematological function, liver function and renal function: Hemoglobin greater than or equal to 9.0 g/dL (which can be maintained or exceeded by blood transfusion); Red blood cell count greater than or equal to 2.0 x 10^12/L; Absolute neutrophil count (ANC) greater than or equal to 1.0x10^9/L; Platelet count greater than or equal to 100 x 10^9/L; Total bilirubin within the normal limit; Upper limit of normal value of alanine glutamate transaminase, straw glutamate transaminase and alkaline phosphatase less than 2.5 times; Creatinine less than or equal to 2.0 mg/dL;Creatinine clearance rate greater than or equal to 60ml/min; The international standardized ratio of prothrombin time (INR) is less than or equal to 1.5 in patients who have not received anticoagulation therapy, and the upper limit of partial thrombin time (APTT) is less than or equal to 1.5 times the normal value. Patients receiving full or extra-gastrointestinal anticoagulant therapy can enter the clinical trial as long as the dose of anticoagulant is stable for at least 2 weeks before entering the clinical study, and the results of the coagulation test test are within the limits of local treatment
	Without systemic metastasis
	With the feasibility of radical surgery therapy
	Patients with normal lung function can tolerate surgery
	The child-bearing female must undergo pregnancy test within 7 days before starting the treatment and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 30 days after completion of the trial. The child-bearing male shall use condom for contraception during the trial and within 30 days after completion of the trial
	Signed and dated informed consent
Exclusion Criteria
	The patient has undergone any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc
	The patient suffered from other cancers besides NSCLC (except cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumor [including Ta and Tis]) within 5 years before the trial
	The patient suffers from any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that starts to attack within the last 3 months, congestive heart failure [ Grade II specified by New York Heart Association (NYHA)], cardiac infarction (6 months before enrollment), severe arrhythmia and liver, kidney or metabolic diseases that requires drug treatment
	Any active, diagnosed or suspected autoimmune diseases
	The patient is allergic to camrelizumab or its any excipients
	The patient has had or is currently suffering from interstitial lung disease
	The patient is a carrier of active hepatitis B, hepatitis C or HIV
	The patient had undergone other major systemic operations or suffered from severe trauma within 2 months before the trial
	Pregnancy or breast-feeding women
	Patients with eurological or psychiatric disorders history including epilepsy or dementia were lack of treatment compliance
	Other situations in which investigators thought the patients not suit to be included

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endobronchial ultrasound

small cell lung cancer

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Neoadjuvant PD-1 Antibody Plus Apatinib or Chemotherapy for Non-small Cell Lung Cancer