Non Small Cell Lung Cancer (Stage III)Phase 2NCT06962189
The Efficacy and Safety of Sintilimab Plus Chemotherapy in Surgical Conversion for Patients With Unresectable Stage IIIB-IIIC NSCLC: A Prospective, Single-Arm, Phase II Study
A Phase 2 study testing chemoimmunothrapy in people with Non Small Cell Lung Cancer (Stage III), run by Zhejiang University.
Trial summary
This study aimed to evaluate the conversion rate to curative-intent treatment in patients with unresectable stage IIIB-IIIC non-small cell lung cancer (NSCLC) following induction therapy with PD-1 blockade combined with chemotherapy, and to assess progression-free survival (PFS) in these patients who underwent… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer (Stage III)
- What is being tested?
- chemoimmunothrapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2025to 31 Dec 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients voluntarily participate in this study and sign informed consent forms (including consent for relevant testing of collected biological samples).
- 2. Histologically or cytologically confirmed NSCLC with no prior antitumor therapy (including systemic medications or local treatments).
- 3.Treatment-naïve patients with unresectable stage IIIB-IIIC NSCLC. 4. Evaluated by a multidisciplinary team (MDT): Surgical resection is not the current preferred treatment option, but radical resection of the primary lung lesion is feasible after induction chemoimmunotherapy, and metastatic contralateral/supraclavicular lymph nodes (if present) are amenable to definitive radiotherapy.
- 5. Aged 18-75 years, regardless of gender. 6. ECOG performance status 0-1. 7. At least one measurable lesion per RECIST v1.1 criteria. 8. All suspicious mediastinal lymph nodes (e.g., pathologically enlarged or PET-CT-suggested malignancy) must undergo pathological confirmation via endobronchial ultrasound (EBUS), thoracoscopy, or mediastinoscopy if technically feasible.
- 9. Pulmonary function (e.g., FVC, FEV1, TLC, FRC, DLco) deemed adequate for planned lung resection by MDT assessment.
- 10. Absence of comorbidities that would elevate surgical risk to unacceptable levels.
- 11. Adequate organ function within 14 days prior to enrollment (no blood components, growth factors, or corrective therapies allowed during this period): Absolute neutrophil count ≥1.5×10⁹/L, Platelets ≥100×10⁹/L, Hemoglobin ≥90 g/L, Serum albumin ≥35 g/L TSH ≤1×ULN, Total bilirubin ≤1.5×ULN, ALT/AST ≤3×ULN, INR ≤1.5 or PT ≤1.5×ULN, Serum creatinine ≤1.5×ULN 12. Non-sterilized or premenopausal female patients must use contraception (e.g., IUD, oral contraceptives, condoms) during the study and for 3 months post-treatment. Non-sterilized females must have a negative serum/urine HCG test within 72 hours before enrollment, be non-lactating, and male patients with fertile partners must use effective contraception during the trial and for 3 months after the last dose.
Who cannot join
- 1. Patients with NSCLC harboring driver mutations (e.g., EGFR, ALK, ROS1). 2. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 therapies targeting T-cell co-stimulatory pathways.
- 3. History of concurrent or other malignancies within the past 3 years (except cured basal cell carcinoma of the skin or cervical carcinoma in situ).
- 4. Active hepatitis B/C with poor response to antiviral therapy. 5. Active autoimmune diseases or history of autoimmune disorders (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism; vitiligo is permitted; childhood asthma resolved without intervention in adulthood is allowed; asthma requiring bronchodilators is excluded).
- 6. Current use of immunosuppressants or systemic corticosteroids (>10 mg/day prednisone equivalent) for immunosuppression within 2 weeks prior to enrollment.
- 7. Poorly controlled hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) or uncontrolled cardiac conditions: NYHA class ≥II heart failure, Unstable angina, Myocardial infarction within 1 year, Clinically significant supraventricular/ventricular arrhythmias requiring treatment, QTc >450 ms (men) or >470 ms (women).
- 8.Coagulopathy (INR >2.0, PT >16 s), bleeding tendency, or ongoing thrombolytic/anticoagulant therapy (prophylactic low-dose aspirin or LMWH is permitted).
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- 9.Arterial/venous thrombotic events within 6 months (e.g., cerebrovascular accident, transient ischemic attack, deep vein thrombosis, pulmonary embolism).
- 10.Hereditary or acquired bleeding/thrombotic disorders (e.g., hemophilia, thrombocytopenia).
- 11. Urinalysis showing proteinuria ≥++ with 24-hour urine protein >1.0 g. 12. Active infection, unexplained fever ≥38.5°C within 7 days prior to treatment, or baseline leukocyte count >15×10⁹/L.
- 13. Congenital or acquired immunodeficiency (e.g., HIV infection). 14. Other factors deemed by the investigator to compromise patient safety or study outcomes (e.g., substance abuse, severe comorbidities, psychiatric disorders, or social circumstances affecting compliance).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Weijia Fang, MD contact
About this study
This study aimed to evaluate the conversion rate to curative-intent treatment in patients with unresectable stage IIIB-IIIC non-small cell lung cancer (NSCLC) following induction therapy with PD-1 blockade combined with chemotherapy, and to assess progression-free survival (PFS) in these patients who underwent curative-intent treatment .
Read the detailed description
This study is a prospective phase II trial designed to evaluate the safety and efficacy of radical resection of the primary lung lesion combined with radical radiotherapy for metastatic lymph nodes, followed by sequential PD-1 inhibitor consolidation therapy, in treatment-naïve patients with unresectable stage IIIB-IIIC non-small cell lung cancer (NSCLC) who received induction therapy with Sintilimab plus platinum-based doublet chemotherapy. The study plans to enroll 39 pathologically confirmed, driver mutation-negative, treatment-naïve stage IIIB-IIIC NSCLC patients. Eligible patients will receive 3-4 cycles of Sintilimab combined with platinum-based doublet induction chemotherapy, followed by assessment for feasibility of radical lung resection.The primary objectives are to evaluate: (1)The conversion rate to curative-intent treatment (radical resection and/or definitive radiotherapy) after induction chemoimmunotherapy in treatment-naïve unresectable stage IIIB-IIIC NSCLC patients; (2) Progression-free survival (PFS) in patients who undergo curative-intent treatment post-induction. Secondary objectives include observation of adverse event rates, objective response rate (ORR), major pathological response (MPR), PFS, overall survival (OS), and exploration of biomarkers associated with treatment efficacy and prognosis.
- Conditions
- Non Small Cell Lung Cancer (Stage III)
- Being tested
- chemoimmunothrapy
- Keywords
- NSCLC, IIIB-IIIC stage, conversion therapy, chemoimmunotherapy
- 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.
chemoimmunothrapyDrug
Patients will receive 3-4 cycles of induction therapy with Sintilimab combined with platinum-based doublet chemotherapy, followed by multidisciplinary team (MDT) evaluation. For patients deemed eligible for radical lung primary lesion resection, surgery should be performed within 4-6 weeks after completing the final cycle of chemoimmunotherapy. The timing of radiotherapy for metastatic lymph nodes will be determined by MDT discussion. If deemed inoperable after induction therapy by MDT, definitive radiotherapy will be administered subsequently. All patients, in the absence of contraindications, will receive PD-1 inhibitor maintenance therapy for 1 year following local treatment.
| Study group | Role | What they receive |
|---|---|---|
| chemoimmunotherapy induction group | Experimental | For treatment-naive patients with unresectable IIIB-IIIC stage NSCLC, 3-4 cycles of induction chemoimmunotherapy, then radical pulmonary resection± definitive radiotherapy for metastatic lymph nodes, then PD-1 inhibitor maintenance therapy for 1 year Receives: Drug: chemoimmunothrapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
conversion rate
the conversion rate to curative primary lung lesion resetion in patients with unresectable stage IIIB-IIIC NSCLC following induction chemoimmunotherapy
Measured: up to 20 weeks
1-y PFS
the proportion of patients without disease progression in one year after the initial dose of chemoimmumotherapy
Measured: within one year
Secondary outcomes (6)
safety
types and incidence of adverse events occurring during the treatment period
Measured: up to 2 years
the rate of major pathological response (MPR)
the proportion of patients who achieve MRP among those receiving pneumonectomy
Measured: up to 20 weeks
the rate of pathological complete response (pCR)
the proportion of patients who achieve pCR among those receiving pneumonectomy
Measured: up to 20 weeks
PFS
progression-free survival
Measured: 5 years
OS
overall survival
Measured: 5 years
the incidence of radiation pneumonitis
the incidence of radiation pneumonitis
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start15 May 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (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 III)Studies of the same condition, open and under way.
- More trials run by Zhejiang 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
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijia Fang, MD, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962189
- Sponsor's protocol ID
- CITRAD
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Sintilimab Plus Chemotherapy in Surgical Conversion for Patients With Unresectable Stage IIIB-IIIC NSCLC: A Prospective, Single-Arm, Phase II Study
- ClinicalTrials.gov ID
- NCT06962189
- Acronym / sponsor ID
- CITRAD
- Conditions
- Non Small Cell Lung Cancer (Stage III)
- Keywords
- NSCLC, IIIB-IIIC stage, conversion therapy, chemoimmunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 May 2025 (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 study aimed to evaluate the conversion rate to curative-intent treatment in patients with unresectable stage IIIB-IIIC non-small cell lung cancer (NSCLC) following induction therapy with PD-1 blockade combined with chemotherapy, and to assess progression-free survival (PFS) in these patients who underwent curative-intent treatment .
Detailed description
This study is a prospective phase II trial designed to evaluate the safety and efficacy of radical resection of the primary lung lesion combined with radical radiotherapy for metastatic lymph nodes, followed by sequential PD-1 inhibitor consolidation therapy, in treatment-naïve patients with unresectable stage IIIB-IIIC non-small cell lung cancer (NSCLC) who received induction therapy with Sintilimab plus platinum-based doublet chemotherapy. The study plans to enroll 39 pathologically confirmed, driver mutation-negative, treatment-naïve stage IIIB-IIIC NSCLC patients. Eligible patients will receive 3-4 cycles of Sintilimab combined with platinum-based doublet induction chemotherapy, followed by assessment for feasibility of radical lung resection.The primary objectives are to evaluate: (1)The conversion rate to curative-intent treatment (radical resection and/or definitive radiotherapy) after induction chemoimmunotherapy in treatment-naïve unresectable stage IIIB-IIIC NSCLC patients; (2) Progression-free survival (PFS) in patients who undergo curative-intent treatment post-induction. Secondary objectives include observation of adverse event rates, objective response rate (ORR), major pathological response (MPR), PFS, overall survival (OS), and exploration of biomarkers associated with treatment efficacy and prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chemoimmunotherapy induction group | Experimental | Drug: chemoimmunothrapyFor treatment-naive patients with unresectable IIIB-IIIC stage NSCLC, 3-4 cycles of induction chemoimmunotherapy, then radical pulmonary resection± definitive radiotherapy for metastatic lymph nodes, then PD-1 inhibitor maintenance therapy for 1 year |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Patients voluntarily participate in this study and sign informed consent forms (including consent for relevant testing of collected biological samples).
- 2. Histologically or cytologically confirmed NSCLC with no prior antitumor therapy (including systemic medications or local treatments).
- 3.Treatment-naïve patients with unresectable stage IIIB-IIIC NSCLC. 4. Evaluated by a multidisciplinary team (MDT): Surgical resection is not the current preferred treatment option, but radical resection of the primary lung lesion is feasible after induction chemoimmunotherapy, and metastatic contralateral/supraclavicular lymph nodes (if present) are amenable to definitive radiotherapy.
- 5. Aged 18-75 years, regardless of gender. 6. ECOG performance status 0-1. 7. At least one measurable lesion per RECIST v1.1 criteria. 8. All suspicious mediastinal lymph nodes (e.g., pathologically enlarged or PET-CT-suggested malignancy) must undergo pathological confirmation via endobronchial ultrasound (EBUS), thoracoscopy, or mediastinoscopy if technically feasible.
- 9. Pulmonary function (e.g., FVC, FEV1, TLC, FRC, DLco) deemed adequate for planned lung resection by MDT assessment.
Key exclusion criteria (10 listed)
- 1. Patients with NSCLC harboring driver mutations (e.g., EGFR, ALK, ROS1). 2. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 therapies targeting T-cell co-stimulatory pathways.
- 3. History of concurrent or other malignancies within the past 3 years (except cured basal cell carcinoma of the skin or cervical carcinoma in situ).
- 4. Active hepatitis B/C with poor response to antiviral therapy. 5. Active autoimmune diseases or history of autoimmune disorders (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism; vitiligo is permitted; childhood asthma resolved without intervention in adulthood is allowed; asthma requiring bronchodilators is excluded).
- 6. Current use of immunosuppressants or systemic corticosteroids (>10 mg/day prednisone equivalent) for immunosuppression within 2 weeks prior to enrollment.
- 7. Poorly controlled hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) or uncontrolled cardiac conditions: NYHA class ≥II heart failure, Unstable angina, Myocardial infarction within 1 year, Clinically significant supraventricular/ventricular arrhythmias requiring treatment, QTc >450 ms (men) or >470 ms (women).
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 |
|---|---|---|
| chemoimmunothrapyPatients will receive 3-4 cycles of induction therapy with Sintilimab combined with platinum-based doublet chemotherapy, followed by multidisciplinary team (MDT) evaluation. For patients deemed eligible for radical lung primary lesion resection, surgery should be performed within 4-6 weeks after completing the final cycle of chemoimmunotherapy. The timing of radiotherapy for metastatic lymph nodes will be determined by MDT discussion. If deemed inoperable after induction therapy by MDT, definitive radiotherapy will be administered subsequently. All patients, in the absence of contraindications, will receive PD-1 inhibitor maintenance therapy for 1 year following local treatment. | Drug | chemoimmunotherapy induction group |
Primary outcome
conversion rate
Time frame: up to 20 weeks
the conversion rate to curative primary lung lesion resetion in patients with unresectable stage IIIB-IIIC NSCLC following induction chemoimmunotherapy
1-y PFS
Time frame: within one year
the proportion of patients without disease progression in one year after the initial dose of chemoimmumotherapy
6 secondary outcomes
safety
Time frame: up to 2 years
the rate of major pathological response (MPR)
Time frame: up to 20 weeks
the rate of pathological complete response (pCR)
Time frame: up to 20 weeks
PFS
Time frame: 5 years
OS
Time frame: 5 years
the incidence of radiation pneumonitis
Time frame: 1-2 years
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 8 May 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.
Weijia Fang, MD contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing chemoimmunothrapy in people with Non Small Cell Lung Cancer (Stage III), run by Zhejiang University.
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 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: opening soon, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Xuqi Sun (+86-18767186629, sunxq@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
conversion rate (time frame: up to 20 weeks). The study lists 2 primary outcomes in all. 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 8 May 2025.