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A Study Evaluating Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade for Limited-stage Small Cell Lung Cancer

ConditionSmall-Cell Lung Cancer (SCLC)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

This study will enroll patients with limited-stage small cell lung cancer (SCLC). Patients will receive chemotherapy (etoposide and platinum-based drugs) combined with dual immune checkpoint blockade (PD-1/CTLA-4) and thymosin alpha 1, with a total cycles of 4. Thoracic radiotherapy was performed no later than the three cycle of chemotherapy. Prophylactic cranial irradiation was recommended for patients who received complete response or partial response after chemoradiotherapy. Finally consolidation therapy with dual immune checkpoint blockade (PD-1/CTLA-4) and thymosin alpha 1 was conducted for one year. The study aims to evaluate the efficacy and safety of this treatment regimen.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males or females aged 18 to 75 years or older;

Patients must have histologically or cytologically confirmed small cell lung cancer (SCLC);

Stage II-III according to AJCC 8th staging system;

No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy;

Disqualifiers

Concurrent enrolment in another clinical study, unless it is an observational(non-interventional) clinical study;

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

Prior use of anti-PD-1, anti-PD-L1, or anti-CTLA4 antibodies;

Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access;

Trial design

Design model

Single group

Treatments tested in this trial

  • Immuno-chemotherapy

    Drug

    Immuno-chemotherapy regimen included etoposide, cisplatin, iparomlimab and tuvonralimab, and thymosin alpha 1.

  • Radiotherapy

    Radiation

    Definitive dose of thoracic radiotherapy was delivered no later than the three cycle of immuno-chemotherapy. Prophylactic cranial irradiation (PCI) was delivered with a total dose of 25Gy in 10 fractions. PCI was recommended for patients who achieved complete response or partial response after thoracic chemoradiotherapy.

  • Consolidative therapy

    Drug

    Consolidation therapy regimen included iparomlimab and tuvonralimab, and thymosin alpha 1, with a duration of one year.

Treatment groups

56 Participants
are divided into 1 treatment group
Group A: The study groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival

PFS measures the time from the start date of treatment to disease progression, death from any cause or last follow up if alive.

Time frame
2-year

Secondary outcomes

1

Overall survival

OS measures the time from the start date of treatment to death from any cause or last follow up if alive.

Time frame
2-year
2

Treatment-related toxicity

Treatment-related toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) 5.0 toxicity

Time frame
through study completion, an average of 18 months

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

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