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A Study of SHR-A2102 in Combination With Adebrelimab and SHR-8068 in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

About this trial

This study is a multicenter, open-label, dose-finding/efficacy-expanding Phase IB/II clinical trial to evaluate SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer. The study consists of two phases: Phase IB to explore the safety/tolerability of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer; Phase II: To explore the efficacy of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.

Age 18~70 years old.

Pathologically confirmed unresectable locally advanced/metastatic non-small cell lung cancer.

At least one measurable lesion per RECIST v1.1 criteria.

Disqualifiers

Active or symptomatic brain metastases.

Previous diagnosis of any other malignancy.

Clinically symptomatic moderate to severe ascites; Uncontrollable or moderate or above pleural effusion, pericardial effusion.

Received anti-tumor therapy 4 weeks prior to initiation of study treatment.

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-A2102

    Drug

    SHR-A2102: injection, 80mg/ bottle, intravenous drip

  • Adebelimab (SHR-1316)

    Drug

    Adebelimab (SHR-1316): injection, 600mg(12mL)/ bottle, intravenous drip

  • SHR-8068

    Drug

    SHR-8068: injection, 50mg（10mL）/ bottle, intravenous drip

Treatment groups

124 Participants
are divided into 1 treatment group
Group A: SHR-A2102 in Combination with Adebrelimab and SHR-8068Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Determination of Recommended Phase II dose (RP2D)

Time frame
From first dose of study treatment until the end of Cycle 1（up to 21 days）
2

Objective Response Rate (ORR)

The percentage of participants with a confirmed CR or PR according to RECIST v1.1 criteria.

Time frame
From time of first dose of SHR-A2102 or Adebrelimab or SHR-8068 until the date of objective disease progression or death (up to 12 months)
3

Incidence and severity of AEs

Time frame
The observation period ended at the end of the 21-day period after the first dose of SHR-A2102 or Adebrelimab or SHR-8068 (up to 21 days)

Secondary outcomes

1

Disease Control Rate (DCR)

The percentage of participants who have a best objective response of confirmed CR or PR or who have SD after start of treatment.

Time frame
From time of first dose of SHR-A2102 or Adebrelimab or SHR-8068 until the date of objective disease progression or death (up to 12 months)
2

Duration of Response (DoR)

The time from the date of first response until date of disease progression or death in the absence of disease progression.

Time frame
From time of first dose of objective disease progression until the date of objective disease progression or death (up to 12 months)]
3

Progression free Survival (PFS)

Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death.

Time frame
From time of first dose of objective disease progression until the date of objective disease progression or death (up to 12 months)
4

Overall Survival (OS)

The time until death due to any cause.

Time frame
From time of first dose of objective disease progression until the date of death (up to 24 months)

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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