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A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer

ConditionNon-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

About this trial

The study is a Phase II study to explore the efficacy and safety of SHR-A2102 in combination with other anti-tumor therapies as perioperative treatment in patients with resectable non-small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent form in writing;

Participants must be aged between 18 and 70 years old (inclusive) when signing the informed consent form, and both men and women are eligible;

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;

Adequate organ function;

Disqualifiers

With active, known or suspected autoimmune disease of autoimmune disease;

Malignancies other than NSCLC within 5 years prior to randomization;

Has or suspected has a history of pneumonitis / interstitial lung disease or any serve lung diseases which will influence the examination of lung function;

Significant history of cardiovascular and cerebrovascular disease; Significant haemorrhagic disease;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-A2102

    Drug

    SHR-A2102.

  • Adebrelimab

    Drug

    Adebrelimab.

  • Paclitaxel

    Drug

    Paclitaxel.

  • Carboplatin

    Drug

    Carboplatin.

  • Alomnertinib Mesilate

    Drug

    Alomnertinib Mesilate.

  • Furmonertini Mesilate

    Drug

    Furmonertini Mesilate.

  • Osimertinib Mesylate

    Drug

    Osimertinib Mesylate.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: SHR-A2102 + Adebrelimab + Paclitaxel + Carboplatin GroupExperimental treatment 4 interventions
Group B: SHR-A2102 + Alomnertinib/Osimertinib/Furmonertinib GroupActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Pathology complete response (pCR)

Time frame
Up to approximately 20 weeks.
2

18-month event free rate

Time frame
Up to approximately 18 months.
3

2-years disease free rate

Time frame
Up to approximately 2 years.

Secondary outcomes

1

Event free survival (EFS)

Time frame
Up to approximately 5 years.
2

Overall survival (OS)

Time frame
Up to approximately 5 years.
3

Objective response rate (ORR)

Time frame
Up to approximately 20 weeks.
4

Disease-Free Survival (DFS)

Time frame
Up to approximately 5 years.

Other outcomes

Sponsors and contacts

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

Shanghai Hengrui Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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