Lung DiseasesPhase 2NCT04371796
Sintilimab (IBI308) in the Neoadjuvant Treatment of Patients With Resectable II-IIIA NSCLC
A Phase 2 study testing Sintilimab injection in people with Lung Diseases and Neoplasms, run by Sichuan Cancer Hospital and Research Institute.
Trial summary
The aim of this study was to investigate the safety and efficacy of Sintilimab (IBI308) in patients with resectable NSCLC, and to provide new treatment options for neoadjuvant therapy in patients with stage II-IIIA NSCLC Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Diseases, Neoplasms, Respiratory Tract Diseases
- 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
- 20 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2020to 30 Dec 2021
- Phase
- Phase 2
- 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
- Age: 18 years old to 75 years old, male or female;
- Histologically or cytologically confirmed NSCLC (stage II-IIIA, American Joint Committee on Cancer, eighth edition) that was surgically resectable;
- Being treatment-naive and the diameter of primary tumor was greater than or equal to 1 cm;
- ECOG performance status score: 0-1;
- The function of important organs meets the following requirements (no blood components and cell growth factors are allowed for 2 weeks before the start of study): Absolute neutrophil count (ANC)≥1.5×10 E+9/L; platelets≥100×10E+9/L / L; hemoglobin ≥9g/dL; serum albumin(ALB)≥2.8g/dL; a total bilirubin (TBil) of≤1.5 ULN, ALT and AST≤2.5 ULN, in case of liver metastasis, ALT and AST≤5 ULN; creatinine clearance rate≥ 50mL/min(Cockcroft-Gault);thyroid function is normal.
- Estimated survival time≥3 months;
- PD-L1 expression level ≥ 1%；
- Patients were voluntarily enrolled in the study and signed an informed consent form (ICF) with good adherence and follow-up.
Who cannot join
- The patient has any active autoimmune disease or a history of autoimmune disease;
- The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppression purposes (dose>10 mg / day of prednisone or other therapeutic hormones);
- History of interstitial lung disease;
- Severe allergic reactions to other monoclonal antibodies;
- Previous allogeneic organ transplantation or hemopoietic stem cell transplantation;
- Have clinical symptoms or disease that are not well controlled ;
Show all 13Show fewer
- Grade III to grade IV congestive heart failure;
- Uncontrolled hypertension;
- Artery thrombosis, embolism, or ischemia within 6 months before study treatment;
- Coagulation disorders;
- Active and uncontrolled infection;
- The patient has previously received other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1;
- Any other known malignant tumor;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Exploratory Efficacy and Safety Study of PD-1 Inhibitor Sintilimab (IBI308) in the Neoadjuvant Treatment of Patients With Resectable II-IIIA NSCLC
The aim of this study was to investigate the safety and efficacy of Sintilimab (IBI308) in patients with resectable NSCLC, and to provide new treatment options for neoadjuvant therapy in patients with stage II-IIIA NSCLC
Read the detailed description
Sintilimab injection (IBI308) as neoadjuvant therapy in patients with resectable NSCLC
- Conditions
- Lung Diseases, Neoplasms, Respiratory Tract Diseases, Thoracic Neoplasms, Non-small-cell Lung Cancer
- Being tested
- Sintilimab injection
- Keywords
- NSCLC, neoadjuvant, Sintilimab
- Medical subject headings
- Lung Diseases, Neoplasms, Respiratory Tract Diseases, Thoracic Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab injectionDrug
Also called IBI308, Xindili Dankang
Sintilimab injection 200mg, 2cycles of treatment before surgery
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab injection | Experimental | * Drugs: Eligible patients received two doses of intravenous sintilimab (200 mg) every 3 weeks (Q3W). Each infusion time is 30-60min.
* Surgery: The patient underwent imaging examinations within 7 days prior to surgery, including chest CT and related metastatic examinations. The patient underwent surgery 6-8 weeks after the first dose. Receives: Drug: Sintilimab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathologic response rate(MPR)(<10% viable tumor cells)
To assess the major pathologic response rate (<10% viable tumor cells) in patients receiving Sintilimab Injection
Measured: At time of surgery
Secondary outcomes (5)
Disease Control Rate (DCR)
the proportion of patients with a best overall response of CR, PR or SD in the whole body, as assessed per RECIST 1.1 by the investigator.
Measured: up to 2 years
Overall response rate (ORR)
the proportion of patients with a best overall confirmed response of CR or PR in the whole body as assessed per RECIST 1.1 by the investigator
Measured: up to 2 years
Disease-free survival (DFS)
Defined as the time from date of surgery until recurrence of tumor or death from any cause
Measured: up to 2 years
Incidence of irAEs
Immune-related AE per Common Terminology Criteria for Adverse Events (CTCAE V5.0)
Measured: up to 2 years
Incidence of SAEs
Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start10 May 2020 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Innovent Biologics, Inc.
- Responsible party
- Principal investigator, Juan LI, MD, Sichuan Cancer Hospital and Research Institute
- Investigators
- Juan Li, MD, Principal investigator, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371796
- Sponsor's protocol ID
- EK2019001
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2020
- Last updated
- 1 May 2020
- 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 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Efficacy and Safety Study of PD-1 Inhibitor Sintilimab (IBI308) in the Neoadjuvant Treatment of Patients With Resectable II-IIIA NSCLC
- ClinicalTrials.gov ID
- NCT04371796
- Acronym / sponsor ID
- EK2019001
- Conditions
- Lung Diseases, Neoplasms, Respiratory Tract Diseases, Thoracic Neoplasms, Non-small-cell Lung Cancer
- Keywords
- NSCLC, neoadjuvant, Sintilimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Collaborators
- Innovent Biologics, Inc.
- Study start
- 10 May 2020 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 1 May 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.
The aim of this study was to investigate the safety and efficacy of Sintilimab (IBI308) in patients with resectable NSCLC, and to provide new treatment options for neoadjuvant therapy in patients with stage II-IIIA NSCLC
Detailed description
Sintilimab injection (IBI308) as neoadjuvant therapy in patients with resectable NSCLC
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sintilimab injection | Experimental | Drug: Sintilimab injection* Drugs: Eligible patients received two doses of intravenous sintilimab (200 mg) every 3 weeks (Q3W). Each infusion time is 30-60min. * Surgery: The patient underwent imaging examinations within 7 days prior to surgery, including chest CT and related metastatic examinations. The patient underwent surgery 6-8 weeks after the first dose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 18 years old to 75 years old, male or female;
- Histologically or cytologically confirmed NSCLC (stage II-IIIA, American Joint Committee on Cancer, eighth edition) that was surgically resectable;
- Being treatment-naive and the diameter of primary tumor was greater than or equal to 1 cm;
- ECOG performance status score: 0-1;
- The function of important organs meets the following requirements (no blood components and cell growth factors are allowed for 2 weeks before the start of study): Absolute neutrophil count (ANC)≥1.5×10 E+9/L; platelets≥100×10E+9/L / L; hemoglobin ≥9g/dL; serum albumin(ALB)≥2.8g/dL; a total bilirubin (TBil) of≤1.5 ULN, ALT and AST≤2.5 ULN, in case of liver metastasis, ALT and AST≤5 ULN; creatinine clearance rate≥ 50mL/min(Cockcroft-Gault);thyroid function is normal.
Key exclusion criteria (13 listed)
- The patient has any active autoimmune disease or a history of autoimmune disease;
- The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppression purposes (dose>10 mg / day of prednisone or other therapeutic hormones);
- History of interstitial lung disease;
- Severe allergic reactions to other monoclonal antibodies;
- Previous allogeneic organ transplantation or hemopoietic stem cell transplantation;
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 injectionAlso: IBI308, Xindili DankangSintilimab injection 200mg, 2cycles of treatment before surgery | Drug | Sintilimab injection |
Primary outcome
Major pathologic response rate(MPR)(<10% viable tumor cells)
Time frame: At time of surgery
To assess the major pathologic response rate (<10% viable tumor cells) in patients receiving Sintilimab Injection
5 secondary outcomes
Disease Control Rate (DCR)
Time frame: up to 2 years
Overall response rate (ORR)
Time frame: up to 2 years
Disease-free survival (DFS)
Time frame: up to 2 years
Incidence of irAEs
Time frame: up to 2 years
Incidence of SAEs
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Individual participant dataSharing planned: No
Related trials for Lung Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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.
Juan Li, MD principal investigator
Sichuan Cancer Hospital and Research Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab injection in people with Lung Diseases and Neoplasms, run by Sichuan Cancer Hospital and Research Institute.
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 8 inclusion and 13 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 1 May 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Li, MD (+8613880276636, dr.lijuan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathologic response rate(MPR)(<10% viable tumor cells) (time frame: At time of surgery). 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 May 2020.