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SHR-1701 for Induction and Consolidation Therapy in Unresectable Stage III Non-Small Cell Lung Cancer

ConditionsNSCLC Stage IIISHR-1701Chemoradiotherapy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

This randomized phase II exploratory clinical study aims to evaluate the efficacy and safety of SHR-1701 in patients with unresectable stage III non-small cell lung cancer (NSCLC). A total of 84 eligible patients will be randomized 1:1 into an induction immunotherapy group or a consolidation immunotherapy group. Group A will receive SHR-1701 combined with platinum-based chemotherapy as induction therapy followed by concurrent chemoradiotherapy (cCRT) and subsequent SHR-1701 consolidation therapy, while Group B will receive standard cCRT followed by SHR-1701 consolidation therapy. The primary endpoint is progression-free survival (PFS). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years, male or female.

Baseline ECOG performance status 0-1.

Histologically or cytologically confirmed unresectable stage III NSCLC

Life expectancy ≥3 months

Disqualifiers

Mixed small-cell and non-small-cell lung cancer histology

Known EGFR/ALK/ROS1 mutations

Prior systemic anti-cancer therapy within 4 weeks

Active autoimmune disease requiring systemic treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-1701 combined with platinum-doublet chemotherapy induction therapy

    Drug

    SHR-1701 combined with platinum-doublet chemotherapy induction therapy

  • SHR-1701 consolidation therapy

    Drug

    SHR-1701 consolidation therapy

  • Platinum-doublet chemotherapy

    Drug

    Platinum-doublet chemotherapy

  • radiotherapy

    Radiation

    Thoracic concurrent radiotherapy, total dose 60 Gy ±10%

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: SHR-1701 induction GroupExperimental treatment 4 interventions
Group B: Control GroupActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

Time frame
4 years

Secondary outcomes

1

Objective Response Rate (ORR)

Time frame
4 years
2

Disease Control Rate (DCR)

Time frame
4 years
3

Overall Survival (OS)

Time frame
4 years
4

Treatment-Related Adverse Events (TRAE)

Time frame
4 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Fudan University

Lead sponsor

Source ClinicalTrials.gov

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