Non-small Cell Lung Cancer (NSCLC)Phase 1NCT05088967

Efficacy and Safety of IBI110 in Combination With Sintilimab Versus Sintilimab Alone in Neoadjuvant and Adjuvant Therapy of Radically Resectable Non-small Cell Lung Cancer

A Phase 1 study testing IBI110 and sintilimab in people with Non-small Cell Lung Cancer (NSCLC), run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The main purpose of this study is to evaluate the neoadjuvant therapy efficacy of IBI110 in combination with sintilimab versus sintilimab alone based on pathologic complete response (pCR) rate in stage IIB (primary tumor > 4 cm ) to IIIB (N2 only) subjects with radically resectable NSCLC. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-small Cell Lung Cancer (NSCLC)
What is being tested?: IBI110 and sintilimab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteChina
Study dates: 2 Dec 2021to 25 Dec 2023
Phase: Phase 1
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have NSCLC that has been classified as stage IIB (primary tumor > 4 cm), IIIA, or IIIB (N2 only) per the 8th edition of TNM staging system of International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC).
Subjects with non-squamous NSCLC should undergo genetic testing to confirm the absence of epidermal growth factor receptor (EGFR) sensitizing mutations or anaplastic lymphoma kinase (ALK) rearrangements;
Eligible for radical resection (R0 resection) at the thoracic surgeon's discretion, and the lung function meets the criteria for planned surgery;
Have at least one measurable lesion per RECIST v1.1 criteria;
Have a performance scale of 0 or 1 on the Eastern Cooperative Oncology Group Performance Status (ECOG PS)

Who cannot join

Have pathological evidence for small cell carcinoma, neuroendocrine carcinoma, sarcoma, lymphoepithelial rumen carcinoma, salivary gland tumor, or mesenchymal tumor from the biopsy.
Have been previously exposed to immune-mediated therapies, including but not limited to LAG-3 antibody drugs, anti-cytotoxic T lymphocyte antigen-4 (CTLA-4), anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies.

Trial locations and contacts

1 site in 1 country.

China1 site

Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000

Other trials in China

About this study

Official title: A Randomized, Open-label, Phase Ib Clinical Study to Evaluate the Efficacy and Safety of IBI110 in Combination With Sintilimab Versus Sintilimab Alone in Neoadjuvant and Adjuvant Therapy of Radically Resectable Non-small Cell Lung Cancer

Conditions: Non-small Cell Lung Cancer (NSCLC)
Being tested: IBI110, sintilimab
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.

IBI110Drug
R2PD d1 IV every 3 weeks
sintilimabDrug
200mg d1 IV every 3 weeks

Study groups in NCT05088967
Study group	Role	What they receive
IBI110+sintilimab	Experimental	IBI110 and sintilimab will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks) for 3 cycles during the neoadjuvant treatment phase. IBI110 and sintilimab will be administered as IV infusion 3 weeks during the post-operative adjuvant phase up to 1 year. Receives: Drug: IBI110; Drug: sintilimab
sintilimab	Active comparator	Sintilimab will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks) for 3 cycles during the neoadjuvant treatment phase. Sintilimab will be administered as IV infusion 3 weeks during the post-operative adjuvant phase up to 1 year. Receives: Drug: sintilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

pCR
defined as having no residual visible tumor cells in the surgically resected primary tumor and lymph node samples (ypT0N0)
Measured: Approximately 21 to 28 days after operation
Incidence of serious adverse events (SAEs), treatment-emergent AEs (TEAEs) and immune-related AEs (irAEs)
An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. A TEAE will be defined as any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment has been administered. irAEs will be assessed.
Measured: up to 90 days after the last administration
Number of participants with abnormality in vital signs
Blood pressure, pulse, respiratory rate, and temperature will be assessed.
Measured: up to 90 days after the last administration
Number of participants with abnormality in hematology parameters
Blood samples will be collected to evaluate hemoglobin, mean corpuscular volume (MCV), white blood cell (WBC) count, platelets, 5-part differential white cell count, mean platelet volume and coagulation factors including international normalized ratio (INR), activated partial thromboplastin time (aPTT) and prothrombin time (PT).
Measured: up to 90 days after the last administration
Number of participants with abnormality in clinical chemistry parameters
Blood samples will be collected to evaluate sodium, potassium, calcium, magnesium, chloride, glucose, creatinine, urea or blood urea nitrogen (BUN), bicarbonate, amylase, bilirubin, alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total protein, albumin, lactate dehydrogenase and lipase.
Measured: up to 90 days after the last administration
Number of participants with abnormality in clinical chemistry parameters
Blood samples will be collected to evaluate sodium, potassium, calcium, magnesium, chloride, glucose, creatinine, urea or BUN, bicarbonate, amylase, bilirubin, alkaline phosphatase, AST, ALT, total protein, albumin, lactate dehydrogenase and lipase.
Measured: up to 90 days after the last administration
Number of participants with abnormality in routine urinalysis parameters
Urine samples will be collected to evaluate specific gravity, leucocyte esterase, nitrite, blood, bilirubin, protein, glucose, ketones and urobilinogen.
Measured: up to 90 days after the last administration
Number of participants with abnormality in ECG parameters
12-lead ECG will be obtained using an ECG machine. Participants will be in supine or a semi-recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes before ECGs are recorded.
Measured: up to 90 days after the last administration

Secondary outcomes (11)

EFS （Event Free Survival）
defined as time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, or death due to any cause
Measured: up to 3 years
major pathological response (MPR) rate
defined as ≤ 10% residual viable tumor cells in the surgically resected primary tumor and lymph nodes
Measured: Approximately 21 to 28 days after operation
radical resection (R0 resection) rate
defined as free resection margins, systematic node dissection or sampling, and the highest mediastinal node negative for tumor
Measured: Approximately 21 to 28 days after operation
ORR （Objective Response rate,）
defined as the ratio of subjects who have achieved investigator assessed complete response (CR) and partial response (PR) per RECIST v1.1
Measured: Within 7 days before surgery
OS （Overall Survival）
defined as the time from randomization to death from any cause
Measured: up to 3 years
Immunogenicity
includes the positive rate of anti-drug antibody (ADA) and neutralizing antibody (NAb) in subjects
Measured: From date of randomization to 30 days after last dose of the drug
maximum concentrations (Cmax )
Maximum serum concentration that IBI110 and Sintilimab achieves in the body after the drug has been administered and before the administration of a second dose.
Measured: from first administration of IBI110 to 3 days before the operation
the area under the drug plasma concentration-time curve (AUC)
Area under the concentration-time curve from time zero to last measurable concentration (AUC)
Measured: from first administration of IBI110 to 3 days before the operation
half-life (t1/2)
defined as the time it takes for the concentration of IBI110 and Sintilimab in the plasma or the total amount in the body to be reduced by 50%.
Measured: from first administration of IBI110 to 3 days before the operation
clearance (CL)
a pharmacokinetic measurement of the volume of plasma from which IBI110 and Sintilimab are completely removed per unit time
Measured: from first administration of IBI110 to 3 days before the operation
volume of distribution (V).
calculated by the amount of the drug in the body divided by the plasma concentration.
Measured: from first administration of IBI110 to 3 days before the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 202125 Dec 2023

First posted22 Oct 2021
Study start2 Dec 2021
Primary completion31 Dec 2021
Study completion25 Dec 2023

Why it stopped: Development strategy adjustment

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 (NSCLC)Studies of the same condition, open and under way.
More trials run by Innovent Biologics (Suzhou) Co. Ltd.The 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05088967
Sponsor's protocol ID: CIBI110C201
Status last verified: Jan 2024
First submitted: 28 Sep 2021
Last updated: 16 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Phase Ib Clinical Study to Evaluate the Efficacy and Safety of IBI110 in Combination With Sintilimab Versus Sintilimab Alone in Neoadjuvant and Adjuvant Therapy of Radically Resectable Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT05088967
Acronym / sponsor ID: CIBI110C201
Conditions: Non-small Cell Lung Cancer (NSCLC)
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Development strategy adjustment
Enrolment: 6 participants (actual)
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
Study start: 2 Dec 2021 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 25 Dec 2023 (actual)
First posted: 22 Oct 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
IBI110+sintilimab	Experimental	Drug: IBI110, Drug: sintilimabIBI110 and sintilimab will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks) for 3 cycles during the neoadjuvant treatment phase. IBI110 and sintilimab will be administered as IV infusion 3 weeks during the post-operative adjuvant phase up to 1 year.
sintilimab	Active comparator	Drug: sintilimabSintilimab will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks) for 3 cycles during the neoadjuvant treatment phase. Sintilimab will be administered as IV infusion 3 weeks during the post-operative adjuvant phase up to 1 year.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Have NSCLC that has been classified as stage IIB (primary tumor > 4 cm), IIIA, or IIIB (N2 only) per the 8th edition of TNM staging system of International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC).
Subjects with non-squamous NSCLC should undergo genetic testing to confirm the absence of epidermal growth factor receptor (EGFR) sensitizing mutations or anaplastic lymphoma kinase (ALK) rearrangements;
Eligible for radical resection (R0 resection) at the thoracic surgeon's discretion, and the lung function meets the criteria for planned surgery;
Have at least one measurable lesion per RECIST v1.1 criteria;
Have a performance scale of 0 or 1 on the Eastern Cooperative Oncology Group Performance Status (ECOG PS)

Key exclusion criteria (2 listed)

Have pathological evidence for small cell carcinoma, neuroendocrine carcinoma, sarcoma, lymphoepithelial rumen carcinoma, salivary gland tumor, or mesenchymal tumor from the biopsy.
Have been previously exposed to immune-mediated therapies, including but not limited to LAG-3 antibody drugs, anti-cytotoxic T lymphocyte antigen-4 (CTLA-4), anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies.

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
IBI110R2PD d1 IV every 3 weeks	Drug	IBI110+sintilimab
sintilimab200mg d1 IV every 3 weeks	Drug	IBI110+sintilimab, sintilimab

Primary outcome

pCR
Time frame: Approximately 21 to 28 days after operation
defined as having no residual visible tumor cells in the surgically resected primary tumor and lymph node samples (ypT0N0)
Incidence of serious adverse events (SAEs), treatment-emergent AEs (TEAEs) and immune-related AEs (irAEs)
Time frame: up to 90 days after the last administration
An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. A TEAE will be defined as any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment has been administered. irAEs will be assessed.
Number of participants with abnormality in vital signs
Time frame: up to 90 days after the last administration
Blood pressure, pulse, respiratory rate, and temperature will be assessed.
Number of participants with abnormality in hematology parameters
Time frame: up to 90 days after the last administration
Blood samples will be collected to evaluate hemoglobin, mean corpuscular volume (MCV), white blood cell (WBC) count, platelets, 5-part differential white cell count, mean platelet volume and coagulation factors including international normalized ratio (INR), activated partial thromboplastin time (aPTT) and prothrombin time (PT).
Number of participants with abnormality in clinical chemistry parameters
Time frame: up to 90 days after the last administration
Blood samples will be collected to evaluate sodium, potassium, calcium, magnesium, chloride, glucose, creatinine, urea or blood urea nitrogen (BUN), bicarbonate, amylase, bilirubin, alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total protein, albumin, lactate dehydrogenase and lipase.
Number of participants with abnormality in clinical chemistry parameters
Time frame: up to 90 days after the last administration
Blood samples will be collected to evaluate sodium, potassium, calcium, magnesium, chloride, glucose, creatinine, urea or BUN, bicarbonate, amylase, bilirubin, alkaline phosphatase, AST, ALT, total protein, albumin, lactate dehydrogenase and lipase.
Number of participants with abnormality in routine urinalysis parameters
Time frame: up to 90 days after the last administration
Urine samples will be collected to evaluate specific gravity, leucocyte esterase, nitrite, blood, bilirubin, protein, glucose, ketones and urobilinogen.
Number of participants with abnormality in ECG parameters
Time frame: up to 90 days after the last administration
12-lead ECG will be obtained using an ECG machine. Participants will be in supine or a semi-recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes before ECGs are recorded.

11 secondary outcomes

EFS （Event Free Survival）
Time frame: up to 3 years
major pathological response (MPR) rate
Time frame: Approximately 21 to 28 days after operation
radical resection (R0 resection) rate
Time frame: Approximately 21 to 28 days after operation
ORR （Objective Response rate,）
Time frame: Within 7 days before surgery
OS （Overall Survival）
Time frame: up to 3 years
Immunogenicity
Time frame: From date of randomization to 30 days after last dose of the drug
maximum concentrations (Cmax )
Time frame: from first administration of IBI110 to 3 days before the operation
the area under the drug plasma concentration-time curve (AUC)
Time frame: from first administration of IBI110 to 3 days before the operation
half-life (t1/2)
Time frame: from first administration of IBI110 to 3 days before the operation
clearance (CL)
Time frame: from first administration of IBI110 to 3 days before the operation
volume of distribution (V).
Time frame: from first administration of IBI110 to 3 days before the operation

Results and safety

The study was stopped early (reason given: Development strategy adjustment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
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.

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 1 study testing IBI110 and sintilimab in people with Non-small Cell Lung Cancer (NSCLC), run by Innovent Biologics (Suzhou) Co. Ltd. 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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 16 Jan 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Development strategy adjustment). Results are not available in the source record.

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?

pCR (time frame: Approximately 21 to 28 days after operation). The study lists 8 primary outcomes in all. 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 NCT05088967.

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 16 Jan 2024.