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OpenTrials
Completed

NCT Number: NCT04672369

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

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jilin Province Cancer Hospital

Jilin City, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed the Informed Consent Form;
  • Male or female ≥ 18 and≤75 years of age;
  • Life expectancy ≥ 12 weeks;
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 or 1
  • 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.
  • Histologically or cytologically confirmednon-small cell lung cancer

Exclusion criteria

  • Previous exposure to immune-mediated therapy; previous use of antitumor vaccine;
  • Received the last anti-tumor therapy within 4 weeks prior to the first dose of study drug;
  • Received any investigational agent within 4 weeks prior to the first dose of study drug;
  • 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;
  • Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study;

Treatment and study plan

IBI939

Biological

IBI939 injection

Sintilimab

Biological

Sintilimab injection

Primary outcomes

  1. Objective response rate(ORR)

    Time frame: 6 months

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

Secondary outcomes

  1. adverse event

    Time frame: 3 months

  2. Progression-free survival(PFS)

    Time frame: 6 months

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

  3. Overall Survival(OS)

    Time frame: 6 months

    The time from randomization to death due to any cause.

  4. Disease Control Rate(DCR)

    Time frame: 6 months

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

  5. Duration of Response (DoR)

    Time frame: 6 months

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

  6. Time to Objective Response(TTR)

    Time frame: 6 months

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

  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

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 17, 2020
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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