A Phase II Clinical Study of SHR-7787 Injection Combined With SHR-1316 Injection in Patients With LS-SCLC

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

About this trial

This study is an open-label, multicenter, phase II clinical study designed to evaluate the preliminary efficacy, safety, and tolerability of SHR-7787 in combination with Adebrelimab in patients with limited-stage small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate in this clinical study, understand the study procedures, and be able to sign the informed consent form (ICF) in writing.

Aged 18 to 75 years (inclusive), of any gender.

Histologically or cytologically confirmed unresectable limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemotherapy and radiation therapy.

ECOG performance status score of 0 or 1.

Disqualifiers

Combined small cell lung cancer or any transformed small cell lung cancer.

History of other malignancies within 5 years prior to the first dose of the study drug.

Severe cardiovascular or cerebrovascular diseases.

Bleeding symptoms of significant clinical relevance within 3 months prior to the first dose of the study drug.

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-7787 Injection

    Drug

    SHR-7787 injection.

  • SHR-1316

    Drug

    SHR-1316 (Adebrelimab) Injection.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: SHR-7787 (Dose 1) + SHR-1316 groupExperimental treatment 2 interventions
Group B: SHR-7787 (Dose 2) + SHR-1316 groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence and severity of adverse events (AEs)

The dose expansion part of Phase 1

Time frame
Approximately 3 weeks
2

Incidence and severity of serious adverse events (SAEs)

The dose expansion part of Phase 1

Time frame
Approximately 3 weeks
3

Progression-Free Survival (PFS)

The dose expansion part of Phase 1

Time frame
Approximately 16 months
4

Progression-Free Survival (PFS)

The efficacy expansion part of Phase 2

Time frame
Approximately 16 months

Secondary outcomes

1

Overall Survival (OS)

The dose expansion part of Phase 1

Time frame
Approximately 16 months
2

Objective Response Rate (ORR)

The dose expansion part of Phase 1

Time frame
Approximately 16 months
3

Duration of Response (DoR)

The dose expansion part of Phase 1

Time frame
Approximately 16 months
4

Anti-Drug Antibody (ADA) of SHR-7787

The dose expansion part of Phase 1

Time frame
Approximately 16 months

Other outcomes

Sponsors and contacts

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