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An Open, Multicenter Phase II Clinical Trial of SHR-A2009 Combined With Other Anti-tumor Therapies for Perioperative Treatment of Resectable Non-small Cell Lung Cancer.

ConditionNon-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

The study is being conducted to evaluate the efficacy, and safety of SHR-A2009 combined with other anti-tumor therapies for perioperative treatment of resectable non-small cell lung cancer in adults.

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.

The ECOG score was 0 or 1.

Pathologically confirmed NSCLC, assessed as resectable or previously resected (R0).

Disqualifiers

Participants who received systemic immunostimulatory therapy within 4 weeks prior to the first dose.

Participants who received systemic immunosuppressive therapy within 2 weeks before the first dose.

Participants with active, known or suspected autoimmune diseases.

Other malignant tumors within 5 years before screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • adebrelimab + SHR-A2009

    Drug

    adebrelimab + SHR-A2009

  • paclitaxel or pemetrexed combined with carboplatin +adebrelimab

    Drug

    paclitaxel or pemetrexed combined with carboplatin +adebrelimab

  • adebrelimab + SHR-A2009

    Drug

    adebrelimab + SHR-A2009 (longer-interval regimen arm)

  • adebrelimab + SHR-A2009

    Drug

    adebrelimab + SHR-A2009 (shorter-interval regimen arm)

  • adebrelimab

    Drug

    adebrelimab

  • adebeliizumab + SHR-A2009

    Drug

    adebeliizumab + SHR-A2009 (longer-interval regimen arm)

  • adebeliizumab + SHR-A2009

    Drug

    adebeliizumab + SHR-A2009 (shorter-interval regimen arm)

  • adebeliizumab + platinum-containing double chemotherapy

    Drug

    adebeliizumab + platinum-containing double chemotherapy

  • almonertinib combined with SHR-A2009

    Drug

    almonertinib combined with SHR-A2009 (longer-interval regimen arm)

  • almonertinib combined with SHR-A2009

    Drug

    almonertinib combined with SHR-A2009 (shorter-interval regimen arm)

  • almonertinib

    Drug

    almonertinib

  • SHR-A2009 combined with almonertinib

    Drug

    SHR-A2009 combined with almonertinib

  • almonertinib monotherapy

    Drug

    almonertinib monotherapy

Treatment groups

660 Participants
are divided into 13 treatment groups

13

Treatment groups

See each treatment group below.

Group A: group A1-1adebrelimab + SHR-A2009Experimental treatment 1 intervention
Group B: group A1-2 paclitaxel or pemetrexed combined with carboplatin +adebrelimabActive comparator 1 intervention
Group C: group1 A2-1adebrelimab + SHR-A2009 (longer-interval regimen arm)Experimental treatment 1 intervention
Group D: group2 A2-2adebrelimab + SHR-A2009 (shorter-interval regimen arm)Experimental treatment 1 intervention
Group E: group A2-3 adebrelimabActive comparator 1 intervention
Group F: group1 A3-1 adebeliizumab + SHR-A2009 (longer-interval regimen arm)Experimental treatment 1 intervention
Group G: group2 A3-2 adebeliizumab + SHR-A2009 (shorter-interval regimen arm)Experimental treatment 1 intervention
Group H: group A3-3 adebeliizumab + platinum-containing double chemotherapyActive comparator 1 intervention
Group I: group B1-1 almonertinib combined with SHR-A2009 (longer-interval regimen arm)Experimental treatment 1 intervention
Group J: group B1-2 almonertinib combined with SHR-A2009 (shorter-interval regimen arm)Experimental treatment 1 intervention
Group K: group B1-3 almonertinibActive comparator 1 intervention
Group L: group B2-1 SHR-A2009 combined with almonertinibExperimental treatment 1 intervention
Group M: group B2-2 almonertinib monotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Part A1 : pCR rate;

Time frame
about 24 months
2

Part A2 : 2-year DFS rate;

Time frame
about 24 months
3

Part A3 : pCR rate and 18-month EFS rate;

Time frame
about 18 months
4

Part B1 : 2-year DFS rate.

Time frame
about 24 months

Secondary outcomes

1

The incidence and grade of adverse events;

Time frame
about 48 months
2

surgical complications;

Time frame
about 24 months
3

EFS

Time frame
about 24 months ;
4

ORR;

Time frame
about 24 months

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: