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NSCLC (Non-small-cell Lung Cancer)Phase 1NCT05118334

IBI310 (Anti-CTLA-4) in Combination With Sintilimab in Patients With Non-small-cell Lung Cancer (NSCLC)

A Phase 1 study testing Sintilimab and IBI310 in people with NSCLC (Non-small-cell Lung Cancer), run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open label, multicenter, phase Ib study evaluating IBI310 (anti-CTLA-4) in combination with Sintilimab in patients with advanced, recurrent or metastatic non-small-cell lung cancer (NSCLC) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC (Non-small-cell Lung Cancer)
What is being tested?
Sintilimab and IBI310
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
12 Nov 2021to 17 Feb 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

None listed.

Who cannot join

  • Had tumors other than NSCLC within the past 5 years.
  • Had allogeneic organ or stem cell transplantation.
  • The presence of uncontrolled life-threatening illness
  • Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
  • Patients who have used large doses of glucocorticoids, anti-cancer monoclonal antibodies, and other immunosuppressive agents within 4 weeks.
  • HIV positive.
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  • Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
  • Severe, uncontrolled medical conditions and infections.
  • At the same time using other test drugs or in other clinical trials.
  • Refusal or inability to sign informed consent to participate in the trial.
  • Other treatment contraindications.
  • Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.
  • Hepatitis B surface antigen (HBsAg) positive and HBVDNA ≥1000cps/ml.
  • Patients with positive HCV antibody test results can only be included in the study when the polymerase chain reaction of HCV RNA is negative.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

Other trials in China

About this study

Official title: An Open Label, Multicenter, Phase Ib Study Evaluating IBI310 (Anti-CTLA-4) in Combination With Sintilimab in Patients With Advanced, Recurrent or Metastatic Non-small-cell Lung Cancer (NSCLC)

This is an open label, multicenter, phase Ib study evaluating IBI310 (anti-CTLA-4) in combination with Sintilimab in patients with advanced, recurrent or metastatic non-small-cell lung cancer (NSCLC)

Being tested
Sintilimab, IBI310
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.

  • SintilimabDrug

    (IBI310 1mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W)until progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.

  • IBI310Drug

    (IBI310 1mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W) until progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.

Study groups in NCT05118334
Study groupRoleWhat they receive
IBI310 (anti-CTLA-4) 1mg/kg(Q3W until progressive disease)in combination with SintilimabExperimentalThe test group will be treated with IBI310 1mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W until progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
Receives: Drug: Sintilimab; Drug: IBI310
IBI310 (anti-CTLA-4) 1mg/kg(Q3W*4cycles)in combination with SintilimabExperimentalThe test group will be treated with IBI310 1mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W*4cycles,and then Sintilimab 200 mg IV, Q3W single until progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
Receives: Drug: Sintilimab; Drug: IBI310
IBI310 (anti-CTLA-4) 1mg/kg(Q6W)in combination with SintilimabExperimentalThe test group will be treated with IBI310 1mg/kg IV, Q6W+ Sintilimab 200 mg IV, Q3Wuntil progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
Receives: Drug: Sintilimab; Drug: IBI310
IBI310 (anti-CTLA-4) 0.5mg/kg in combination with SintilimabExperimentalThe test group will be treated with IBI310 0.5mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W until progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
Receives: Drug: Sintilimab; Drug: IBI310

What is being measured

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

  1. Objective Response Rate(ORR)

    Investigator evaluated ORR per RECIST V1.1

    Measured: Up to 2 years

  2. Treatment Emergent Adverse Event (TEAE)

    Incidence and severity of treatment-emergent: which is evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, v5.0) grade;

    Measured: Up to 2 years

  3. Severe Adverse Event (SAE)

    Incidence and severity of treatment-emergent: which is evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, v5.0) grade;

    Measured: Up to 2 years

Secondary outcomes (6)

  1. DOR

    Defined as the time from the first documented objective response to the first documented progressive disease or death of any cause, whichever occurs first;

    Measured: Up to 2 years

  2. Progression Free Survival (PFS)

    Defined as the time from randomization to the first documented progressive disease or death of any cause, whichever occurs first;

    Measured: Up to 2 years

  3. Overall Survival (OS)

    Defined as the time from randomization to death of any cause in subjects without receiving any immunotherapy outside the study protocol for first-line treatment of advanced NSCLC

    Measured: Up to 2 years

  4. Disease Control Rate (DCR)

    Defined as the proportion of patients whose best response is CR, PR, and stable disease (SD) non-CR/non-PD

    Measured: Up to 2 years

  5. Time to Response (TTR)

    Defined as the time from randomization to the first documented and confirmed objective response (CR or PR)

    Measured: Up to 2 years

  6. HRQoL

    According to EORTC QLQ-C30

    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.

  1. First posted11 Nov 2021
  2. Study start12 Nov 2021
  3. Primary completion31 Jul 2022
  4. Study completion17 Feb 2023

Resources

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
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05118334
Sponsor's protocol ID
CIBI310H201
Status last verified
Feb 2023
First submitted
1 Nov 2021
Last updated
23 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhao Y, Chen X, Yao J, Long J, Mao Y, Wu D, Zang A, Zhao J, Liu Z, Meng R, Chen Y, Luo Y, Guo Q, Li L, Cui J. A phase Ib study evaluating the safety and efficacy of IBI310 plus sintilimab in patients with advanced non-small-cell lung cancer who have progressed after anti-PD-1/L1 therapy. Cancer Med. 2024 Feb;13(3):e6855. doi: 10.1002/cam4.6855. Epub 2024 Jan 12.

    PubMed 38214075

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sintilimab and IBI310 in people with NSCLC (Non-small-cell Lung Cancer), 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 0 inclusion and 14 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: finished, as of the sponsor's last update on 23 Feb 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Objective Response Rate(ORR) (time frame: Up to 2 years). The study lists 3 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 NCT05118334, 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 23 Feb 2023.

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