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The Clinical Study of Adalimumab Combined With Other Anti-tumor Therapy as a Treatment for Resectable Non-small Cell Lung Cancer

ConditionResectable Non-small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

This study is an open-label, multicenter phase II clinical trial of adebelizumab combined with other anti-tumor therapies in patients with non-small cell lung cancer. The aim of this study was to evaluate the safety, tolerability and efficacy of adebelizumab combined with other anti-tumor therapies in patients with resectable non-small cell lung cancer ( NSCLC )

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

voluntarily participate in this clinical study, understand the research procedure and be able to sign the informed consent in writing ;

At the time of signing the informed consent form, the age is 18-70 years old ( including both ends ), both men and women can.

Disqualifiers

Small cell lung cancer ( SCLC ) and NSCLC mixed tumors confirmed by histology or cytology contain non-NSCLC pathological types such as small cell components.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adebrelimab Injection combined with SHR-1826 Injection combined with SHR-8068 Injection

    Drug

    Adebrelimab Injection combined with SHR-1826 Injection combined with SHR-8068 Injection

  • Adebrelimab Injection combined with HRS-7058 Capsule

    Drug

    Adebrelimab Injection combined with HRS-7058 Capsule

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: PART AExperimental treatment 1 intervention
Group B: PART BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pathological complete response (pCR) rate: pCR is defined as the absence of any residual tumor at the time of surgical resection.

Time frame
All results are expected to be obtained in the last participant three months after surgery.

Secondary outcomes

1

Event-free survival (EFS)

EFS is defined as the time from the first dose to any of the following events: any progression of disease precluding surgery; progression or recurrent disease based on investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after surgery; or death from any cause.

Time frame
In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
2

Disease-free survival (DFS) as assessed byinvestigator

DFS is defined as the time from firste dose to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.

Time frame
In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
3

Objective response rate (ORR): assessed by the investigator

Time frame
In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
4

Overall Survival (OS)

OS is defined as the time from first dose to death due to any cause.

Time frame
In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: