RecruitingPhase 1Phase 2NCT06477523

Phase 1b/2 Study of LDRT in Combination With AK104 Plus Chemotherapy as First-line Treatment for ES-SCLC

Phase 1b/2 Study of AK104 (Anti-PD1/CTLA4 Bispecific Antibody) in Combination With Etoposide and Carboplatin Plus Low-dose Radiotherapy (LDRT) for the First-line Treatment of Patients With Extensive Stage Small Cell Lung Cancer


Sponsor

Sichuan University

Enrollment

57 participants

Start Date

May 16, 2024

Study Type

INTERVENTIONAL

Summary

Phase Ib/II, open-label, multicentre study to evaluate the efficacy and safety of low-dose radiotherapy (LDRT) combined with AK104 and chemotherapy as first-line treatment for patients with ES-SCLC.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding low-dose radiation therapy to a combination of immunotherapy (AK104) and chemotherapy improves outcomes for patients with extensive-stage small cell lung cancer — an aggressive form of lung cancer that has spread beyond one side of the chest. **You may be eligible if...** - You are between 18 and 80 years old - You have been confirmed to have extensive-stage small cell lung cancer - You are in good enough health to tolerate chemotherapy, immunotherapy, and radiation **You may NOT be eligible if...** - Your cancer is limited-stage (confined to one side of the chest) - Your organ function is too impaired to tolerate combination treatment - You have active autoimmune disease or other conditions that prevent immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAK104

IV infusion

DRUGEtoposide

Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4).

DRUGCarboplatin

Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).

RADIATIONlow-dose radiotherapy

The subjects will receive LDRT, from C1D1-C1D5, once a day for 3Gy, until the target dose of 15Gy is achieved (Cycles 1). LDRT treatment for primary/mediastinal positive lymph nodes/metastatic lesions during maintenance therapy (C1D1-C1D5, 15Gy).


Locations(2)

China West Hospital

Chengdu, Sichuan, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06477523