Association Between Microbiome and the Efficacy and Safety of PD-1/PD-L1 Blockade in Resectable NSCLC

NCT ID: NCT06613308

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-25
• Study Completion Date: 2025-12-31

Brief Summary

This study will investigate the relationship between respiratory and gut microbiome and PD-1/PD-L1 immune checkpoint inhibitor efficacy and immune-related adverse events (irAE) in patients with non-small cell lung cancer (Stage IIA-IIIB）

Conditions

Lung Cancer (NSCLC)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Arm1(Neoadjuvant immunotherapy combined with chemotherapy)

Neoadjuvant immunotherapy combined with chemotherapy

Intervention Type: DRUG

The treatment regimen consisted of a PD-1/PD-L1 monoclonal antibody in combination with a platinum-containing two-agent standard chemotherapy regimen administered every three weeks. Following two to four cycles of therapy, patients who demonstrated no evidence of disease progression were eligible for surgical resection, which was performed within three to four weeks after the conclusion of the last neoadjuvant therapy. Consolidation with a PD-1/PD-L1 monoclonal antibody was initiated within three to eight weeks after surgery and continued every three weeks. The efficacy of the treatment was evaluated according to the irRECIST criteria. Chemotherapy regimens were selected based on tumour histology and investigator judgement. In the event of poor tolerability, patients may switch between cisplatin or carboplatin treatments.

Arm2(Neoadjuvant chemotherapy)

Neoadjuvant chemotherapy

Intervention Type: DRUG

A platinum-containing two-agent standard chemotherapy regimen was administered every three weeks. Following a two-to-four-cycle therapy, if the patients were evaluated without progressive disease, patients undergo surgical resection within three to four weeks of the final neoadjuvant treatment. Postoperative adjuvant chemotherapy is then conducted in accordance with the recommended regimen outlined in the 2022 edition of the CSCO Guidelines for the Diagnosis and Treatment of Non-Small Cell Lung Cancer. The efficacy of the treatment was evaluated in accordance with the RECIST 1.1 criteria.

The chemotherapy regimens were selected based on the tumor histology and the judgement of the investigators, in accordance with the standard clinical practice. In the event of poor tolerability, patients may switch between cisplatin or carboplatin treatments.

Interventions

Neoadjuvant immunotherapy combined with chemotherapy

The treatment regimen consisted of a PD-1/PD-L1 monoclonal antibody in combination with a platinum-containing two-agent standard chemotherapy regimen administered every three weeks. Following two to four cycles of therapy, patients who demonstrated no evidence of disease progression were eligible for surgical resection, which was performed within three to four weeks after the conclusion of the last neoadjuvant therapy. Consolidation with a PD-1/PD-L1 monoclonal antibody was initiated within three to eight weeks after surgery and continued every three weeks. The efficacy of the treatment was evaluated according to the irRECIST criteria. Chemotherapy regimens were selected based on tumour histology and investigator judgement. In the event of poor tolerability, patients may switch between cisplatin or carboplatin treatments.

Intervention Type: DRUG

Neoadjuvant chemotherapy

A platinum-containing two-agent standard chemotherapy regimen was administered every three weeks. Following a two-to-four-cycle therapy, if the patients were evaluated without progressive disease, patients undergo surgical resection within three to four weeks of the final neoadjuvant treatment. Postoperative adjuvant chemotherapy is then conducted in accordance with the recommended regimen outlined in the 2022 edition of the CSCO Guidelines for the Diagnosis and Treatment of Non-Small Cell Lung Cancer. The efficacy of the treatment was evaluated in accordance with the RECIST 1.1 criteria.

The chemotherapy regimens were selected based on the tumor histology and the judgement of the investigators, in accordance with the standard clinical practice. In the event of poor tolerability, patients may switch between cisplatin or carboplatin treatments.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18-75 years old;
• first-diagnosed, driver gene-negative non-small cell lung cancer patients with histopathological confirmed diagnosis (Stage IIA-IIIB);
• at least 1 measurable lesion as defined by RECIST version 1.1; an Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1;
• no prior systemic therapy or radiotherapy;
• the patients are eligible for indications for surgical resection and amenable to - neoadjuvant immunotherapy or chemotherapy after multidisciplinary evaluation;
• signing the written consent before enrollment in the study;
• participants need to have adequate pulmonary ventilation and diffusion function to allow surgical resection by pre-enrolment pulmonary function testing;

Exclusion Criteria

• refusal of participation or inability to give a clear consent;
• requiring treatment with systemic glucocorticoids and other - immunosuppressive agents;
• use of antibiotics within the previous 3 months or the presence of an infectious disease requiring antibiotic therapy;
• probiotics within 3 months prior to enrolment;
• presence of obstructive pneumonia, cancerous cavities, active tuberculosis;
• the presence of bronchiectasis, combined lung infections, pulmonary fibrosis, uncontrolled diabetes mellitus;
• the presence of primary tumors elsewhere;
• receiving chemotherapy or any other cancer treatment prior to enrolment;
• participants with brain metastases confirmed by brain MRI with contrast prior to enrolment;
• active or pre-existing autoimmune disease;
• the presence of uncontrolled comorbidities, including heart failure, uncontrolled hypertension, unstable angina, interstitial lung disease;
• positive test for hepatitis B surface antigen or hepatitis C ribonucleic acid requiring treatment;
• known positive history or positive test results for human immunodeficiency virus or acquired immunodeficiency syndrome (AIDS);
• history of allergy to study drug components;
• women who are pregnant or breastfeeding;
• previous treatment with anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibodies.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: collaborator

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Bin Cao

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

science and technology center

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Central Contacts

Yeming Wang, M.D.

Role: CONTACT

wwyymm_love@163.com

+86 84206264

Dong Liu, M.D.

Role: CONTACT

liudongdoc@163.com

Other Identifiers

2022-YJXBF-03-01

Identifier Type: -

Identifier Source: org_study_id