NSCLC, Stage IIIAPhase 3NCT05157776
A Phase III Trial of Neoadjuvant Sintilimab and Chemotherapy for NSCLC Harboring No Driver Mutations
A Phase 3 study testing PD-1 and chemotherapy in people with NSCLC, Stage IIIA and EGF-R Negative Non-Small Cell Lung Cancer, run by Tongji University at 1 site in China.
Trial summary
This is a randomized, open-label study designed to evaluate the safety and efficacy of neoadjuvant PD-1 antibody plus chemotherapy followed by surgery in resectable stage IIIA non-small cell lung cancer. The primary endpoint: pCR rate The second endpoint: MPR, DFS, MRD Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC, Stage IIIA, EGF-R Negative Non-Small Cell Lung Cancer, ALK Negative NSCLC
- What is being tested?
- PD-1 and chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2021to 31 Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resectable stage IIIA NSCLC, EGFR mutation-negative and ALK rearrangement negative (8th UICC TNM staging);
- No prior anti-tumor therapy for NSCLC;
- Age from 18 to 75 years old;
- Adequate organ function:
- Hemoglobin ≥9.0g/L; White blood cell count 4.0~10×109/L; The absolute value of neutrophils (ANC) ≥ 1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤ 1.5 times the upper limit of normal; ALT and AST≤2.5 times the upper limit of normal; The international normalized ratio of prothrombin time is ≤1.5 times the upper limit of normal value, and the partial thromboplastin time is within the range of normal value; Creatinine ≤ 1.5 times the upper limit of normal;
- No chemotherapy, radiotherapy or hormone therapy for malignant tumors, no history of other malignant tumors, excluding patients who have received hormone therapy for prostate cancer and have had DFS for more than 5 years;
- ECOG 0～1;
Who cannot join
- Double primary or multiple primary NSCLC;
- EGFR mutation or ALK mutation was positive
- patients with psychosis;
- Pre-existing or coexisting bleeding disorders;
- Other uncontrollable and inoperable patients;
- Patients whose previous operations have prevented this operation from being performed;
- Female patients who are pregnant or breastfeeding;
- For patients who are allergic to the drugs in the program.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Jiang Fan, MD, 02163240090, fan_jiang@tongji.edu.cn
Jiang Fan, MD
About this study
Official title: Neoadjuvant Sintilimab and Platinum-based Chemotherapy for Resectable Locally Advanced NSCLC Harboring no Driver Mutations: A Prospective, Randomized, Multicenter Phase III Trial
This is a randomized, open-label study designed to evaluate the safety and efficacy of neoadjuvant PD-1 antibody plus chemotherapy followed by surgery in resectable stage IIIA non-small cell lung cancer.
The primary endpoint: pCR rate The second endpoint: MPR, DFS, MRD
Read the detailed description
This study is a prospective, multicenter, phase III randomized controlled clinical study. Stage IIIA NSCLC patients with EGFR mutation negative and ALK rearrangement negative were enrolled, and after 2 courses of treatment with Sintilimab combined with Platinum-based Chemotherapy, they were randomly assigned 1:1 to the control group (surgical resection and postoperative treatment for 2 courses are recommended) or the experimental group (surgery after 2 courses of treatment).
The primary endpoint is pCR rate. The second endpoints are MPR, DFS, and MRD.
- Being tested
- PD-1 and chemotherapy
- Keywords
- Neoadjuvant, PD-1, NSCLC, Phase III, Platinum-based, Locally Advanced
- 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.
PD-1 and chemotherapyDrug
Sintilimab+(Squamous)ABX+DDP/CBP, or (non-Squamous)PEM+DDP/CBP
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Neoadjuvant therapy of Sintilimab and chemotherapy in 2 cycles before surgery and optional adjuvant therapy of Sintilimab and chemotherapy in 2 cycles after surgery Receives: Drug: PD-1 and chemotherapy |
| Experimental group | Experimental | Neoadjuvant therapy of Sintilimab and chemotherapy in 4 cycles before surgery Receives: Drug: PD-1 and chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologically complete response (pCR) rate
Measured: in three weeks after the surgical resection
Secondary outcomes (3)
Major pathological response (MPR) rate
Measured: in three weeks after the surgical resection
Disease-free survival (DFS)
Measured: one, two, three and five years since the initial treatment (each treatment is 2 days)
Minimal residual disease(MRD)
Measured: in one week before each cycle and in the forth week after the surgical resection (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start28 Oct 2021
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NSCLC, Stage IIIAStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiang Fan, Tongji University
- Investigators
- Jiang Fan, MD, Principal investigator, Shanghai General Hospital; Shanghai Pulmonary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157776
- Sponsor's protocol ID
- SGHDOT 21-10
- Status last verified
- May 2023
- First submitted
- 7 Dec 2021
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin D, Wu L, Wang P, Li X, Wang X, Cai Y, Xiong K, Chen X, Yang F, Huang W, Wang X, Fan J. Dynamic circulating tumor DNA indicates pathological benefits of additional neoadjuvant chemoimmunotherapy courses for locally advanced non-small-cell lung cancer patients. Front Oncol. 2025 Jul 24;15:1563315. doi: 10.3389/fonc.2025.1563315. eCollection 2025.
PubMed 40777124
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Sintilimab and Platinum-based Chemotherapy for Resectable Locally Advanced NSCLC Harboring no Driver Mutations: A Prospective, Randomized, Multicenter Phase III Trial
- ClinicalTrials.gov ID
- NCT05157776
- Acronym / sponsor ID
- SGHDOT 21-10
- Keywords
- Neoadjuvant, PD-1, NSCLC, Phase III, Platinum-based, Locally Advanced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 15 Dec 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.
This is a randomized, open-label study designed to evaluate the safety and efficacy of neoadjuvant PD-1 antibody plus chemotherapy followed by surgery in resectable stage IIIA non-small cell lung cancer.
The primary endpoint: pCR rate The second endpoint: MPR, DFS, MRD
Detailed description
This study is a prospective, multicenter, phase III randomized controlled clinical study. Stage IIIA NSCLC patients with EGFR mutation negative and ALK rearrangement negative were enrolled, and after 2 courses of treatment with Sintilimab combined with Platinum-based Chemotherapy, they were randomly assigned 1:1 to the control group (surgical resection and postoperative treatment for 2 courses are recommended) or the experimental group (surgery after 2 courses of treatment).
The primary endpoint is pCR rate. The second endpoints are MPR, DFS, and MRD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: PD-1 and chemotherapyNeoadjuvant therapy of Sintilimab and chemotherapy in 2 cycles before surgery and optional adjuvant therapy of Sintilimab and chemotherapy in 2 cycles after surgery |
| Experimental group | Experimental | Drug: PD-1 and chemotherapyNeoadjuvant therapy of Sintilimab and chemotherapy in 4 cycles before surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Resectable stage IIIA NSCLC, EGFR mutation-negative and ALK rearrangement negative (8th UICC TNM staging);
- No prior anti-tumor therapy for NSCLC;
- Age from 18 to 75 years old;
- Adequate organ function:
- Hemoglobin ≥9.0g/L; White blood cell count 4.0~10×109/L; The absolute value of neutrophils (ANC) ≥ 1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤ 1.5 times the upper limit of normal; ALT and AST≤2.5 times the upper limit of normal; The international normalized ratio of prothrombin time is ≤1.5 times the upper limit of normal value, and the partial thromboplastin time is within the range of normal value; Creatinine ≤ 1.5 times the upper limit of normal;
Key exclusion criteria (8 listed)
- Double primary or multiple primary NSCLC;
- EGFR mutation or ALK mutation was positive
- patients with psychosis;
- Pre-existing or coexisting bleeding disorders;
- Other uncontrollable and inoperable patients;
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 |
|---|---|---|
| PD-1 and chemotherapySintilimab+(Squamous)ABX+DDP/CBP, or (non-Squamous)PEM+DDP/CBP | Drug | Control group, Experimental group |
Primary outcome
Pathologically complete response (pCR) rate
Time frame: in three weeks after the surgical resection
3 secondary outcomes
Major pathological response (MPR) rate
Time frame: in three weeks after the surgical resection
Disease-free survival (DFS)
Time frame: one, two, three and five years since the initial treatment (each treatment is 2 days)
Minimal residual disease(MRD)
Time frame: in one week before each cycle and in the forth week after the surgical resection (each cycle is 21 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Derived from this study: PubMed 40777124Lin D, Wu L, Wang P, Li X, Wang X, Cai Y, Xiong K, Chen X, Yang F, Huang W, Wang X, Fan J. Dynamic circulating tumor DNA indicates pathological benefits of additional neoadjuvant chemoimmunotherapy courses for locally advanced non-small-cell lung cancer patients. Front Oncol. 2025 Jul 24;15:1563315. doi: 10.3389/fonc.2025.1563315. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
Jiang Fan, MD principal investigator
Shanghai General Hospital; Shanghai Pulmonary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PD-1 and chemotherapy in people with NSCLC, Stage IIIA and EGF-R Negative Non-Small Cell Lung Cancer, run by Tongji 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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 May 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiang Fan, MD (15901013210, fan_jiang@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologically complete response (pCR) rate (time frame: in three weeks after the surgical resection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05157776, which also lists 1 linked publication.
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 9 May 2023.