IIIA Stage Non-small Cell Lung CancerPhase 2Neo-Pre-ICNCT04326153
Neoadjuvant Immunotherapy Plus Chemotherapy for Potentially Resectable Stage IIIA/IIIB Non-Small Cell Lung Cancer
A Phase 2 study testing Sintilimab Injection in people with IIIA Stage Non-small Cell Lung Cancer, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
Cancer has always been one of the leading causes of death in the world, and China is facing more and more severe challenges from cancer. Among all the causes of cancer death, lung cancer (25.2%) ranks first, among which non-small cell lung cancer (NSCLC) accounts for about 80% to 85%, of which about 1 / 3 of the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IIIA Stage Non-small Cell Lung Cancer
- What is being tested?
- Sintilimab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2020to 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Asian male or female patients: 18-75 years old;
- ECoG physical condition score: 0-2;
- Histologic examination confirmed that the potential resectable stage IIIA/IIIB non-small cell lung cancer (T4 or N2 according to the TNM staging standard of AJCC 8th Edition);
- Estimated survival time ≥ 12 weeks;
- No systemic anti-tumor therapy has been received before. The function of main organs is normal, that is to say, the relevant examination indexes within 14 days before randomization meet the following requirements:
- 1) Blood routine examination:
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- Hemoglobin ≥ 90 g / L (no blood transfusion within 14 days); b) Neutrophil count ≥ 1.5 × 109 / L; c) Platelet count ≥ 100 × 109 / L;
- 2) Biochemical examination:
- Total bilirubin ≤ 1.5 × ULN (upper limit of normal value); b) ALT or AST ≤ 2.5 × ULN; ALT or AST ≤ 5 × ULN in case of liver metastasis; c) Serum creatinine < 1.5 times of the upper limit of normal value; endogenous creatinine clearance ≥ 50 ml / min (Cockcroft Gault formula);
- 3) Routine coagulation examination:
- INR or PT ≤ 1.5 x ULN.
- APTT ≤ 1.5 x ULN.
- 4) Left ventricular ejection fraction (LVEF) ≥ 50%.
- 7. Pregnant women of childbearing age must carry out pregnancy test (serum or urine) within 7 days before entering the group, and the result is negative, and they are willing to use appropriate methods of contraception during the test and within 8 weeks after the last administration of the test drug. For men, it is necessary to agree to use appropriate methods of contraception or sterilization after operation during the trial period and within 8 weeks after the last administration of the test drug;
- 8. Good compliance, family members agree to cooperate to receive survival follow-up;
- 9. Sign informed consent.
Who cannot join
- There are mixed small cell carcinoma and sarcoma in histology;
- Other malignant tumors were diagnosed within 5 years before administration, excluding radical skin basal cell carcinoma, skin squamous cell carcinoma and / or radical resection of carcinoma in situ. If more than 5 years before the administration of the drug is diagnosed as other malignant tumors or lung cancer, it is necessary to carry out pathological or cytological diagnosis of the recurrent lesions;
- Currently participating in the intervention clinical research and treatment, or receiving other drugs or research instruments within 4 weeks before the first administration;
- Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs for another stimulation or synergistic inhibition of T cell receptor (such as CTLA-4, OX-40, CD137);
- Received immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration, or received major surgical treatment within 3 weeks before the first administration;
- With a history of haemorrhagic disease, any bleeding event with a severe grade of 3 or more in ctcae5.0 occurred within 4 weeks before screening;
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- Received solid organ or blood system transplantation;
- There are clinically uncontrolled active infections, including but not limited to acute pneumonia;
- There were idiopathic pulmonary fibrosis, organic pneumonia (such as bronchiolitis obliterans), and drug-related pneumonia;
- Uncontrollable or symptomatic hypercalcemia;
- III-IV and congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmias;
- It is known to have allergic reactions to PD-1 monoclonal antibody, albumin paclitaxel, carboplatin active ingredients and / or any excipients;
- Active autoimmune diseases requiring systemic treatment (e.g., use of disease improving drugs, corticosteroids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin or corticosteroids in physiological doses for adrenal or pituitary insufficiency) are not considered systemic.
- Patients who need long-term systemic corticosteroid use. Patients with COPD, asthma requiring intermittent use of bronchodilators, inhaled corticosteroids, or local injection of corticosteroids were included.
- Long term unhealed wound or incomplete union fracture;
- Active infection requiring treatment or systemic anti infective drugs used within 1 week before the first administration;
- In the first 6 months of screening, there were arterial thrombosis events, such as cerebrovascular accident (including transient ischemic attack), myocardial infarction, unstable angina, etc;
- For female subjects: they should be surgical sterilization, postmenopausal patients, or agree to use a medically recognized contraceptive measure during the study treatment period and within 6 months after the end of the study treatment period; the serum or urine pregnancy test must be negative within 7 days before the study is enrolled in the group, and must be non lactation period. Male subjects: patients who should be sterilized surgically or who agree to use a medically approved contraceptive method during the study and within 6 months after the end of the study.
- Known human immunodeficiency virus (HIV) infection history (i.e. HIV 1 / 2 antibody positive);
- Untreated active hepatitis B;
- Note: hepatitis B subjects who meet the following criteria also meet the inclusion criteria:
- Before the first administration, HBV viral load must be less than 1000 copies / ml (200iu / ml). Subjects should receive anti HBV treatment during the whole period of chemotherapy drug treatment to avoid virus reactivation. For subjects with anti HBC +, HBsAg (-), anti HBS (-), and HBV viral load (-), prophylactic anti HBV treatment is not required, but virus reactivation needs to be closely detected.
- Active HCV infected subjects (HCV antibody positive and HCV-RNA level higher than the detection limit)
- Those who have a history of abuse of psychotropic substances and are unable to give up or have mental disorders;
- Inoculate the live vaccine within 30 days before the first administration; Note: it is allowed to receive the injection inactivated virus vaccine for seasonal influenza; however, it is not allowed to accept the live attenuated influenza vaccine for intranasal medication.
- There are medical history, disease, treatment or laboratory abnormal results that may interfere with the test results, prevent the subjects from participating in the whole process of the study, or the researchers think that participating in the study is not in the best interests of the subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center Phase 2 Study of Neoadjuvant Immunotherapy Plus Chemotherapy for Potentially Resectable Stage IIIA/IIIB Non-Small Cell Lung Cancer
Cancer has always been one of the leading causes of death in the world, and China is facing more and more severe challenges from cancer. Among all the causes of cancer death, lung cancer (25.2%) ranks first, among which non-small cell lung cancer (NSCLC) accounts for about 80% to 85%, of which about 1 / 3 of the patients have been in the local advanced stage (IIIA stage / IIIB stage) at the time of initial diagnosis. For the patients with stage IIIA NSCLC who can be operated on, surgery is still the most effective way to treat them. Even so, NSCLC in stage I-III undergoing radical surgery is the most effective way 30-60% of the patients eventually had relapse or distant metastasis. Therefore, people began to explore a new treatment mode, preoperative neoadjuvant chemotherapy, to improve the survival rate of NSCLC 2.
At present, the NCCN guidelines for the new adjuvant treatment of NSCLC mainly recommend platinum based dual drug chemotherapy.
Immunotherapy combined with chemotherapy will be a potential new adjuvant therapy in the future, which can improve the resection rate of patients, reduce the recurrence rate after surgery, and have tolerable adverse reactions.
Read the detailed description
Sample size calculation： The primary endpoint is the 2-year DFS rate，however, due to the extended observation time required for this endpoint, it is not suitable for promptly validating treatment response. MPR rate is employed to calculate the necessary sample size.
Simon's optimal two-stage design is utilized. The addition of sintilimab to chemotherapy is assumed to elevate the MPR rate from 8.9% to 35%. The sample size should be 29(17+12). In the first stage, the study will be concluded if ≤2 patients achieve MPR, indicating a negative outcome. Conversely, if more than 4 patients achieve MPR, the study will proceed by enrolling an additional 12 patients. Considering the sample size calculation results and sufficient funding, the final enrollment is 30. The type 1 error rate is 0.05. The outlined protocol yield an 95% statistical power to detect an MPR rate of 35% under alternative hypotheses.
MRD detectition： Using previously retained biomarkers from patients for MRD detection, exploring the relationship between MRD and patient DFS and OS.
- Conditions
- IIIA Stage Non-small Cell Lung Cancer
- Being tested
- Sintilimab Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab InjectionDrug
Preoperative:
Sintilimab: 200mg QD, one cycle every 21 days, the first day of each cycle, a total of two cycles.
Albumin paclitaxel: 135mg / m2 QD, 1 cycle every 21 days, 1 day and 8 days of each cycle, 2 cycles in total.
Carboplatin: AUC 5mg QD, one cycle every 21 days, two cycles in total
Postoperative:
Patients began to receive postoperative adjuvant treatment within 21-60 days after the operation. Specific medication plan:
Sintilimab: 200mg QD, one cycle every 21 days, the first day of each cycle, a total of 8 cycles.
Albumin paclitaxel: 135mg / m2 QD, 1 cycle every 21 days, 1 day and 8 days of each cycle, 2 cycles in total.
Carboplatin: AUC 5mg QD, one cycle every 21 days, two cycles in total.
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | Sintilimab+Albumin paclitaxel:+Carboplatin: Receives: Drug: Sintilimab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 years DFS rate
To evaluate the 2-year DFS rate of neoadjuvant treatment of Asian patients with resectable stage IIIA NSCLC with Sintilimab combined with albumin paclitaxel and carboplatin
Measured: 2 years
Secondary outcomes (7)
MPR rate
Major pathological remission rate
Measured: 36 month
PCR rate
Pathological complete response rate
Measured: 36 month
Downgrade rate
Downgrade rate,including T downgrade and N downgrade
Measured: 36 month
DFS
Disease-free survival
Measured: 36 month
OS
Overall survival
Measured: 36 month
ORR
Objective response rate
Measured: 36 month
TRAE
Treatment-related adverse reactions
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start20 Mar 2020
- Primary completion6 Sep 2023
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IIIA Stage Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326153
- Sponsor's protocol ID
- K2019158
- Acronym
- Neo-Pre-IC
- Status last verified
- Dec 2023
- First submitted
- 17 Mar 2020
- Last updated
- 1 Feb 2024
- Results posted
- 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 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Phase 2 Study of Neoadjuvant Immunotherapy Plus Chemotherapy for Potentially Resectable Stage IIIA/IIIB Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04326153
- Acronym / sponsor ID
- Neo-Pre-IC / K2019158
- Conditions
- IIIA Stage Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Mar 2020 (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.
Cancer has always been one of the leading causes of death in the world, and China is facing more and more severe challenges from cancer. Among all the causes of cancer death, lung cancer (25.2%) ranks first, among which non-small cell lung cancer (NSCLC) accounts for about 80% to 85%, of which about 1 / 3 of the patients have been in the local advanced stage (IIIA stage / IIIB stage) at the time of initial diagnosis. For the patients with stage IIIA NSCLC who can be operated on, surgery is still the most effective way to treat them. Even so, NSCLC in stage I-III undergoing radical surgery is the most effective way 30-60% of the patients eventually had relapse or distant metastasis. Therefore, people began to explore a new treatment mode, preoperative neoadjuvant chemotherapy, to improve the survival rate of NSCLC 2.
At present, the NCCN guidelines for the new adjuvant treatment of NSCLC mainly recommend platinum based dual drug chemotherapy.
Immunotherapy combined with chemotherapy will be a potential new adjuvant therapy in the future, which can improve the resection rate of patients, reduce the recurrence rate after surgery, and have tolerable adverse reactions.
Detailed description
Sample size calculation： The primary endpoint is the 2-year DFS rate，however, due to the extended observation time required for this endpoint, it is not suitable for promptly validating treatment response. MPR rate is employed to calculate the necessary sample size.
Simon's optimal two-stage design is utilized. The addition of sintilimab to chemotherapy is assumed to elevate the MPR rate from 8.9% to 35%. The sample size should be 29(17+12). In the first stage, the study will be concluded if ≤2 patients achieve MPR, indicating a negative outcome. Conversely, if more than 4 patients achieve MPR, the study will proceed by enrolling an additional 12 patients. Considering the sample size calculation results and sufficient funding, the final enrollment is 30. The type 1 error rate is 0.05. The outlined protocol yield an 95% statistical power to detect an MPR rate of 35% under alternative hypotheses.
MRD detectition： Using previously retained biomarkers from patients for MRD detection, exploring the relationship between MRD and patient DFS and OS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Drug: Sintilimab InjectionSintilimab+Albumin paclitaxel:+Carboplatin: |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Asian male or female patients: 18-75 years old;
- ECoG physical condition score: 0-2;
- Histologic examination confirmed that the potential resectable stage IIIA/IIIB non-small cell lung cancer (T4 or N2 according to the TNM staging standard of AJCC 8th Edition);
- Estimated survival time ≥ 12 weeks;
- No systemic anti-tumor therapy has been received before. The function of main organs is normal, that is to say, the relevant examination indexes within 14 days before randomization meet the following requirements:
Key exclusion criteria (26 listed)
- Note: hepatitis B subjects who meet the following criteria also meet the inclusion criteria:
- Before the first administration, HBV viral load must be less than 1000 copies / ml (200iu / ml). Subjects should receive anti HBV treatment during the whole period of chemotherapy drug treatment to avoid virus reactivation. For subjects with anti HBC +, HBsAg (-), anti HBS (-), and HBV viral load (-), prophylactic anti HBV treatment is not required, but virus reactivation needs to be closely detected.
- There are medical history, disease, treatment or laboratory abnormal results that may interfere with the test results, prevent the subjects from participating in the whole process of the study, or the researchers think that participating in the study is not in the best interests of the subjects.
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 |
|---|---|---|
| Sintilimab InjectionPreoperative: Sintilimab: 200mg QD, one cycle every 21 days, the first day of each cycle, a total of two cycles. Albumin paclitaxel: 135mg / m2 QD, 1 cycle every 21 days, 1 day and 8 days of each cycle, 2 cycles in total. Carboplatin: AUC 5mg QD, one cycle every 21 days, two cycles in total Postoperative: Patients began to receive postoperative adjuvant treatment within 21-60 days after the operation. Specific medication plan: Sintilimab: 200mg QD, one cycle every 21 days, the first day of each cycle, a total of 8 cycles. Albumin paclitaxel: 135mg / m2 QD, 1 cycle every 21 days, 1 day and 8 days of each cycle, 2 cycles in total. Carboplatin: AUC 5mg QD, one cycle every 21 days, two cycles in total. | Drug | experimental arm |
Primary outcome
2 years DFS rate
Time frame: 2 years
To evaluate the 2-year DFS rate of neoadjuvant treatment of Asian patients with resectable stage IIIA NSCLC with Sintilimab combined with albumin paclitaxel and carboplatin
7 secondary outcomes
MPR rate
Time frame: 36 month
PCR rate
Time frame: 36 month
Downgrade rate
Time frame: 36 month
DFS
Time frame: 36 month
OS
Time frame: 36 month
ORR
Time frame: 36 month
TRAE
Time frame: 36 month
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 1 Feb 2024.
- Individual participant dataSharing planned: No
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RecruitingPhase 3
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RecruitingPhase 3
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sintilimab Injection in people with IIIA Stage Non-small Cell Lung Cancer, run by The First Hospital of Jilin 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 16 inclusion and 26 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 1 Feb 2024. 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?
2 years DFS rate (time frame: 2 years). 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 1 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.