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Active, not recruitingNCT04699721Updated Oct 2, 2026

Clinical Study of Neoadjuvant Chemotherapy and Immunotherapy Combined With Probiotics in Patients With Resectable NSCLC

A Phase 2 interventional study of Probiotics (BiFico)+nivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC5 in Non-small Cell Lung Cancer Stage II, Non-small Cell Lung Cancer Stage ⅢA and Non-small Cell Lung Cancer Stage IIIB, sponsored by Xiangya Hospital of Central South University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Xiangya Hospital of Central South University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Sep 2020, registered Dec 2020).
Updated Oct 2, 2026Start date movedPrimary completion moved+4 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
65
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

To evaluate the safety and effect of neoadjuvant chemotherapy and immunotherapy combined with probiotics for resectable NSCLC patients.

02

Conditions studied

  • Non-small Cell Lung Cancer Stage II
  • Non-small Cell Lung Cancer Stage ⅢA
  • Non-small Cell Lung Cancer Stage IIIB

Keywords

  • Neoadjuvant therapy
  • Immunotherapy
  • Chemotherapy
  • Probiotics
  • Non-small cell lung cancer (NSCLC)
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 65 is close to the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Xiangya Hospital of Central South University is the lead sponsor of 170 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Histologically or cytologically confirmed previously untreated non-small cell lung cancer.
  2. Patients with resectable stage II, IIIA and IIIB (N2) disease (according to AJCC 8th edition);
  3. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1;
  4. 18 years ≤ Age ≤ 80 years;
  5. Patients with appropriate treatment compliance and could be followed-up correctly;
  6. Patients with measurable or evaluable diseases (according to RECIST 1.1);
  7. Patients must have the ability to swallow oral drugs;
  8. Patients with adequate pulmonary function capable of tolerating the proposed lung resection according to the evidence-based clinical practice guidelines of American College of Chest Physicians;
  9. Signed and dated written informed consent must be provided by the patient prior to admission to the study.

Exclusion criteria

Exclusion Criteria:

  1. Subjects with known ALK translocations or EGFR mutations.
  2. Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll;
  3. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease;
  4. Patients with symptomatic ILD (grade 3-4) and/or poor lung function and a history of interstitial lung disease cannot be included;
  5. Patients with other active malignant tumors currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug;
  6. Patients who are unable to follow the procedures required in the protocol due to any medical, mental or psychological conditions;
  7. Prior treatment with an anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody or any other antibodies or drugs that target T cell costimulation or immune checkpoint pathways;
  8. Known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid indicating acute or chronic infection;
  9. Known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome;
  10. Patients with a history of allergy to study drugs or ingredients.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
65 participants (actual)

Study arms

  • Experimental
    Arm 1

    3 cycles of nivolumab+Paclitaxel (albumin-bound type)+ Carboplatin AUC5 (21 days/cycle); as well as BiFico (oral taking, 4 capsules/time, 2 times per day)

    Drug: Probiotics (BiFico)+nivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC5

Interventions

  • DrugProbiotics (BiFico)+nivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC5

    3 cycles of nivolumab+Paclitaxel (albumin-bound type)+ Carboplatin AUC5 (21 days/cycle); as well as BiFico (oral taking, 4 capsules/time, 2 times per day)

    Also known as: Bifidobacterium trifidum live powder (BiFico, SINE)

06

What researchers measure

Primary outcomes

  1. Pathological complete response

    The percentage of participants with 0% residual viable tumor cells in the primary tumor and sampled lymph nodes after neoadjuvant therapy.

    Time frame: After surgery, based on surgical resection specimens and blinded independent pathological review.

Secondary outcomes

  1. Objective response rate

    The percentage of participants who achieved complete response or partial response after 3 cycles of neoadjuvant therapy according to the RECIST 1.1 criteria.

    Time frame: 21 days (±7 days) after the completion of three cycles of neoadjuvant therapy and before surgery.

  2. Clinical TNM downstaging

    Participants who achieve a a reduction in the corresponding radiological T, N, or overall TNM stage compared with baseline.

    Time frame: 21 days (±7 days) after the completion of three cycles of neoadjuvant therapy and before surgery.

  3. Treatment-related Adverse Events

    The number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

    Time frame: Treatment-related adverse events were assessed between the start of the first neoadjuvant dose and 30 days after the last dose of neoadjuvant study treatment.

  4. Disease free survival

    The time (month) from the completion of lung cancer radical surgery to the recurrence or metastasis of the disease.

    Time frame: 1 year, 3 years and 5 years after the operation

  5. Recurrence rate

    The percentage of participants who have recurrence or metastasis of lung cancer at certain time points after radical surgery.

    Time frame: 1 year, 3 years and 5 years after the operation

  6. Overall survival

    The time (month) from the completion of lung cancer radical surgery to all-cause death.

    Time frame: 1 year, 3 years and 5 years after the operation

07

Study locations

1 site
  • Xiangya Hospital of Central South University
    Changsha, Hunan 410008, China
08

References and documents

Individual participant data

Plan to share: Yes — all IPD that underlie results in a publication

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Start date
Jul 1, 2020→Sep 2, 2020
Oct 2, 2026
Primary completion
Sep 2027→Dec 31, 2024 (actual)
Oct 2, 2026
Enrollment
60 (estimated)→65 (actual)
Oct 2, 2026
Also revised
eligibility, primary outcomes and interventions
Show all 1 update
  1. Oct 2, 2026
    Start date Jul 1, 2020→Sep 2, 2020
    Primary completion Sep 2027→Dec 31, 2024 (now actual)
    Enrollment 60 (estimated)→65 (actual)
    Eligibility Criteria revised
    Primary outcomes Revised (2 changes)
    Interventions Arms or interventions changed
    + 5 other changes: verification date, description, conditions, secondary outcomes and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04699721
Lead sponsor
Xiangya Hospital of Central South University
Responsible party
Sponsor
First posted
Jan 7, 2021
Start date
Sep 2, 2020
Primary completion
Dec 31, 2024
Completion
Dec 31, 2027 (estimated)
Last update
Oct 2, 2026

Study contacts

Yang Gao, Doctor
study director · Xiangya Hospital of Central South University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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