Non-small Cell Lung Cancer Stage IIPhase 2NCT04699721
Clinical Study of Neoadjuvant Chemotherapy and Immunotherapy Combined With Probiotics in Patients With Resectable NSCLC
A Phase 2 study testing Probiotics (BiFico)+nivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC5 in people with Non-small Cell Lung Cancer Stage II and Non-small Cell Lung Cancer Stage ⅢA, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
To evaluate the safety and effect of neoadjuvant chemotherapy and immunotherapy combined with probiotics for resectable NSCLC patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-small Cell Lung Cancer Stage II, Non-small Cell Lung Cancer Stage ⅢA, Non-small Cell Lung Cancer Stage IIIB
- What is being tested?
- Probiotics (BiFico)+nivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC5
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2020to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed previously untreated non-small cell lung cancer.
- Patients with resectable stage II, IIIA and IIIB (N2) disease (according to AJCC 8th edition);
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-1;
- 18 years ≤ Age ≤ 80 years;
- Patients with appropriate treatment compliance and could be followed-up correctly;
- Patients with measurable or evaluable diseases (according to RECIST 1.1);
Show all 9Show fewer
- Patients must have the ability to swallow oral drugs;
- 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;
- Signed and dated written informed consent must be provided by the patient prior to admission to the study.
Who cannot join
- Subjects with known ALK translocations or EGFR mutations.
- 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;
- 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;
- Patients with symptomatic ILD (grade 3-4) and/or poor lung function and a history of interstitial lung disease cannot be included;
- Patients with other active malignant tumors currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug;
- Patients who are unable to follow the procedures required in the protocol due to any medical, mental or psychological conditions;
Show all 10Show fewer
- 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;
- Known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid indicating acute or chronic infection;
- Known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome;
- Patients with a history of allergy to study drugs or ingredients.
Trial locations and contacts
1 site in 1 country.
China1 site
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
About this study
Official title: Clinical Study of Neoadjuvant Chemotherapy and Immunotherapy Combined With Probiotics in Patients With Resectable Non-small Cell Lung Cancer
To evaluate the safety and effect of neoadjuvant chemotherapy and immunotherapy combined with probiotics for resectable NSCLC patients.
- Conditions
- Non-small Cell Lung Cancer Stage II, Non-small Cell Lung Cancer Stage ⅢA, Non-small Cell Lung Cancer Stage IIIB
- Being tested
- Probiotics (BiFico)+nivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC5
- Keywords
- Neoadjuvant therapy, Immunotherapy, Chemotherapy, Probiotics, Non-small cell lung cancer (NSCLC)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics (BiFico)+nivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC5Drug
Also called Bifidobacterium trifidum live powder (BiFico, SINE)
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)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 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) Receives: Drug: Probiotics (BiFico)+nivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response
The percentage of participants with 0% residual viable tumor cells in the primary tumor and sampled lymph nodes after neoadjuvant therapy.
Measured: After surgery, based on surgical resection specimens and blinded independent pathological review.
Secondary outcomes (6)
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.
Measured: 21 days (±7 days) after the completion of three cycles of neoadjuvant therapy and before surgery.
Clinical TNM downstaging
Participants who achieve a a reduction in the corresponding radiological T, N, or overall TNM stage compared with baseline.
Measured: 21 days (±7 days) after the completion of three cycles of neoadjuvant therapy and before surgery.
Treatment-related Adverse Events
The number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: 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.
Disease free survival
The time (month) from the completion of lung cancer radical surgery to the recurrence or metastasis of the disease.
Measured: 1 year, 3 years and 5 years after the operation
Recurrence rate
The percentage of participants who have recurrence or metastasis of lung cancer at certain time points after radical surgery.
Measured: 1 year, 3 years and 5 years after the operation
Overall survival
The time (month) from the completion of lung cancer radical surgery to all-cause death.
Measured: 1 year, 3 years and 5 years after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start2 Sep 2020
- Primary completion31 Dec 2024
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer Stage IIStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yang Gao, Doctor, Study director, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699721
- Sponsor's protocol ID
- 202007093
- Status last verified
- Sep 2026
- First submitted
- 27 Dec 2020
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Neoadjuvant Chemotherapy and Immunotherapy Combined With Probiotics in Patients With Resectable Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04699721
- Acronym / sponsor ID
- 202007093
- Conditions
- 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)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and effect of neoadjuvant chemotherapy and immunotherapy combined with probiotics for resectable NSCLC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Probiotics (BiFico)+nivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC53 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed previously untreated non-small cell lung cancer.
- Patients with resectable stage II, IIIA and IIIB (N2) disease (according to AJCC 8th edition);
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-1;
- 18 years ≤ Age ≤ 80 years;
- Patients with appropriate treatment compliance and could be followed-up correctly;
Key exclusion criteria (10 listed)
- Subjects with known ALK translocations or EGFR mutations.
- 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;
- 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;
- Patients with symptomatic ILD (grade 3-4) and/or poor lung function and a history of interstitial lung disease cannot be included;
- Patients with other active malignant tumors currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotics (BiFico)+nivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC5Also: Bifidobacterium trifidum live powder (BiFico, SINE)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 | Arm 1 |
Primary outcome
Pathological complete response
Time frame: After surgery, based on surgical resection specimens and blinded independent pathological review.
The percentage of participants with 0% residual viable tumor cells in the primary tumor and sampled lymph nodes after neoadjuvant therapy.
6 secondary outcomes
Objective response rate
Time frame: 21 days (±7 days) after the completion of three cycles of neoadjuvant therapy and before surgery.
Clinical TNM downstaging
Time frame: 21 days (±7 days) after the completion of three cycles of neoadjuvant therapy and before surgery.
Treatment-related Adverse Events
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.
Disease free survival
Time frame: 1 year, 3 years and 5 years after the operation
Recurrence rate
Time frame: 1 year, 3 years and 5 years after the operation
Overall survival
Time frame: 1 year, 3 years and 5 years after the operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for Non-small Cell Lung Cancer Stage II
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8
RecruitingPhase 3
A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.
Non Small Cell Lung Cancer
Not yet recruitingPhase 2
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148(ABBV-1480) as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Gao, Doctor study director
Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotics (BiFico)+nivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC5 in people with Non-small Cell Lung Cancer Stage II and Non-small Cell Lung Cancer Stage ⅢA, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (time frame: After surgery, based on surgical resection specimens and blinded independent pathological review.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.