Neoadjuvant Immunotherapy Plus Chemotherapy for Potentially Resectable Stage IIIA/IIIB Non-Small Cell Lung Cancer

NCT04326153 | Active Not Recruiting Phase 2

• 1 other identifier: K2019158
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer has always been one of the leading causes of death in the world, and China is facing more and more severe challenges from cancer. Among all the causes of cancer death, lung cancer (25.2%) ranks first, among which non-small cell lung cancer (NSCLC) accounts for about 80% to 85%, of which about 1 / 3 of the patients have been in the local advanced stage (IIIA stage / IIIB stage) at the time of initial diagnosis. For the patients with stage IIIA NSCLC who can be operated on, surgery is still the most effective way to treat them. Even so, NSCLC in stage I-III undergoing radical surgery is the most effective way 30-60% of the patients eventually had relapse or distant metastasis. Therefore, people began to explore a new treatment mode, preoperative neoadjuvant chemotherapy, to improve the survival rate of NSCLC 2. At present, the NCCN guidelines for the new adjuvant treatment of NSCLC mainly recommend platinum based dual drug chemotherapy. Immunotherapy combined with chemotherapy will be a potential new adjuvant therapy in the future, which can improve the resection rate of patients, reduce the recurrence rate after surgery, and have tolerable adverse reactions.

Conditions

IIIA Stage Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 2 years DFS rate

  To evaluate the 2-year DFS rate of neoadjuvant treatment of Asian patients with resectable stage IIIA NSCLC with Sintilimab combined with albumin paclitaxel and carboplatin

  2 years

Secondary Outcomes (7)

• MPR rate

  36 month

• PCR rate

  36 month

• Downgrade rate

  36 month

• DFS

  36 month

• OS

  36 month

Study Arms (1)

experimental arm

EXPERIMENTAL

Sintilimab+Albumin paclitaxel:+Carboplatin:

Drug: Sintilimab Injection

Interventions

Sintilimab Injection DRUG

Preoperative: Sintilimab: 200mg QD, one cycle every 21 days, the first day of each cycle, a total of two cycles. Albumin paclitaxel: 135mg / m2 QD, 1 cycle every 21 days, 1 day and 8 days of each cycle, 2 cycles in total. Carboplatin: AUC 5mg QD, one cycle every 21 days, two cycles in total Postoperative: Patients began to receive postoperative adjuvant treatment within 21-60 days after the operation. Specific medication plan: Sintilimab: 200mg QD, one cycle every 21 days, the first day of each cycle, a total of 8 cycles. Albumin paclitaxel: 135mg / m2 QD, 1 cycle every 21 days, 1 day and 8 days of each cycle, 2 cycles in total. Carboplatin: AUC 5mg QD, one cycle every 21 days, two cycles in total.

experimental arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Asian male or female patients: 18-75 years old;
• ECoG physical condition score: 0-2;
• Histologic examination confirmed that the potential resectable stage IIIA/IIIB non-small cell lung cancer (T4 or N2 according to the TNM staging standard of AJCC 8th Edition);
• Estimated survival time ≥ 12 weeks;
• No systemic anti-tumor therapy has been received before. The function of main organs is normal, that is to say, the relevant examination indexes within 14 days before randomization meet the following requirements:
• \) Blood routine examination:
• a) Hemoglobin ≥ 90 g / L (no blood transfusion within 14 days); b) Neutrophil count ≥ 1.5 × 109 / L; c) Platelet count ≥ 100 × 109 / L;
• \) Biochemical examination:
• a) Total bilirubin ≤ 1.5 × ULN (upper limit of normal value); b) ALT or AST ≤ 2.5 × ULN; ALT or AST ≤ 5 × ULN in case of liver metastasis; c) Serum creatinine \< 1.5 times of the upper limit of normal value; endogenous creatinine clearance ≥ 50 ml / min (Cockcroft Gault formula);
• \) Routine coagulation examination:
• INR or PT ≤ 1.5 x ULN.
• APTT ≤ 1.5 x ULN.
• \) Left ventricular ejection fraction (LVEF) ≥ 50%.
• \. Pregnant women of childbearing age must carry out pregnancy test (serum or urine) within 7 days before entering the group, and the result is negative, and they are willing to use appropriate methods of contraception during the test and within 8 weeks after the last administration of the test drug. For men, it is necessary to agree to use appropriate methods of contraception or sterilization after operation during the trial period and within 8 weeks after the last administration of the test drug;
• \. Good compliance, family members agree to cooperate to receive survival follow-up;

You may not qualify if:

• There are mixed small cell carcinoma and sarcoma in histology;
• Other malignant tumors were diagnosed within 5 years before administration, excluding radical skin basal cell carcinoma, skin squamous cell carcinoma and / or radical resection of carcinoma in situ. If more than 5 years before the administration of the drug is diagnosed as other malignant tumors or lung cancer, it is necessary to carry out pathological or cytological diagnosis of the recurrent lesions;
• Currently participating in the intervention clinical research and treatment, or receiving other drugs or research instruments within 4 weeks before the first administration;
• Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs for another stimulation or synergistic inhibition of T cell receptor (such as CTLA-4, OX-40, CD137);
• Received immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration, or received major surgical treatment within 3 weeks before the first administration;
• With a history of haemorrhagic disease, any bleeding event with a severe grade of 3 or more in ctcae5.0 occurred within 4 weeks before screening;
• Received solid organ or blood system transplantation;
• There are clinically uncontrolled active infections, including but not limited to acute pneumonia;
• There were idiopathic pulmonary fibrosis, organic pneumonia (such as bronchiolitis obliterans), and drug-related pneumonia;
• Uncontrollable or symptomatic hypercalcemia;
• III-IV and congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmias;
• It is known to have allergic reactions to PD-1 monoclonal antibody, albumin paclitaxel, carboplatin active ingredients and / or any excipients;
• Active autoimmune diseases requiring systemic treatment (e.g., use of disease improving drugs, corticosteroids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin or corticosteroids in physiological doses for adrenal or pituitary insufficiency) are not considered systemic.
• Patients who need long-term systemic corticosteroid use. Patients with COPD, asthma requiring intermittent use of bronchodilators, inhaled corticosteroids, or local injection of corticosteroids were included.
• Long term unhealed wound or incomplete union fracture;

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

The First Hospital Of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Interventions

sintilimab

Study Design

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

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 30, 2020
• Study Start: March 20, 2020
• Primary Completion: September 6, 2023
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 1, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)