Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

March 1, 2024

Primary Completion Date

February 28, 2027

Study Completion Date

February 28, 2027

Conditions
Lung Squamous Cell Carcinoma
Interventions
RADIATION

low-dose radiation therapy and stereotactic body radiation therapy

Patients will receive radiation therapy.

DRUG

chemotherapy

Patients will receive sintilimab combined with standard platinum-based doublet chemotherapy for a total of 4 cycles. Patients subsequently received maintenance treatment with sintilimab, and continued treatment until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor treatments, death, or other circumstances that should stop treatment as specified in the protocol. Whichever occurs first. The maximum treatment time with sintilimab is 24 months (or 35 cycles).

DRUG

Sintilimab

Patients will receive sintilimab combined with standard platinum-based doublet chemotherapy for a total of 4 cycles. Patients subsequently received maintenance treatment with sintilimab, and continued treatment until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor treatments, death, or other circumstances that should stop treatment as specified in the protocol. Whichever occurs first. The maximum treatment time with sintilimab is 24 months (or 35 cycles).

Trial Locations (1)

610044

RECRUITING

West China Hospital of Sichuan University, Chengdu

All Listed Sponsors
collaborator

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

lead

Sichuan University

OTHER

NCT06121505 - Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung Cancer | Biotech Hunter | Biotech Hunter