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CompletedNCT04672369Updated Jun 22, 2023

A Study to Evaluate the Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced NSCLC

A Phase 1 interventional study of IBI939 and Sintilimab in Advanced Lung Cancer, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by Innovent Biologics (Suzhou) Co. Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in subjects with advanced lung cancer.

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Conditions studied

  • Advanced Lung Cancer

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03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 42 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 192 studies on the registry; 44 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Signed the Informed Consent Form;
  2. Male or female ≥ 18 and≤75 years of age;
  3. Life expectancy ≥ 12 weeks;
  4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 or 1
  5. Have at least 1 lesion (not previously irradiated) with an accurately measured longest diameter ≥ 10 mm by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent is preferred) at baseline (except lymph nodes which must have short axis ≥ 15 mm) according to RECIST V1.1 and lesions amenable to repeated accurate measurements.
  6. Histologically or cytologically confirmednon-small cell lung cancer

Exclusion criteria

Exclusion Criteria:

  1. Previous exposure to immune-mediated therapy; previous use of antitumor vaccine;
  2. Received the last anti-tumor therapy within 4 weeks prior to the first dose of study drug;
  3. Received any investigational agent within 4 weeks prior to the first dose of study drug;
  4. Received systemic treatment with Chinese herbal medicine indicated for cancer or drugs used for immunoregulation (including thymosin, interferon, interleukin, except for local use for pleural effusion) within 2 weeks before the first dose;
  5. Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study;
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    IBI939 in combination with Sintilimab

    Biological: IBI939 · Biological: Sintilimab

  • Active comparator
    sintilimab

    Biological: Sintilimab

Interventions

  • BiologicalIBI939

    IBI939 injection

  • BiologicalSintilimab

    Sintilimab injection

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What researchers measure

Primary outcomes

  1. Objective response rate(ORR)

    Proportion of subjects with complete response(CR) or partial response(PR).

    Time frame: 6 months

Secondary outcomes

  1. adverse event

    Time frame: 3 months

  2. Progression-free survival(PFS)

    The time from randomization to the first occurrence of objective disease progression or death

    Time frame: 6 months

  3. Overall Survival(OS)

    The time from randomization to death due to any cause.

    Time frame: 6 months

  4. Disease Control Rate(DCR)

    Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD).

    Time frame: 6 months

  5. Duration of Response (DoR)

    The time from the first documented objective tumor response(CR or PR) to objective disease progression (PD) or death.

    Time frame: 6 months

  6. Time to Objective Response(TTR)

    Time from randomization to first objective tumor response (CR or PR).

    Time frame: 6 months

  7. Area under the plasma concentration-time curve (AUC)

    Time frame: 24 hours

  8. Maximum concentration (Cmax)

    Time frame: 24 hours

  9. Trough concentration (Cmin)

    Time frame: 24 hours

  10. Clearance (CL), 12. volume of distribution (V)

    Time frame: 24 hours

  11. Half-life (t1/2)

    Time frame: 24 hours

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Study locations

1 site
  • Jilin Province Cancer Hospital
    Jilin, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04672369
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Sponsor
First posted
Dec 17, 2020
Start date
Jun 6, 2021
Primary completion
Jan 1, 2023
Completion
Jun 1, 2023
Last update
Jun 22, 2023

Study contacts

Ying Cheng
principal investigator · Jilin Province Cancer Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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