New Protocol: Toripalimab with Chemotherapy for Small Cell Lung Cancer

Multicenter, double-blind, placebo-controlled phase 3 trial (EXTENTORCH)

Previously untreated extensive-stage SCLC

Toripalimab + EP (etoposide + cisplatin/carboplatin) for 4–6 cycles, followed by toripalimab maintenance vs. placebo + EP

ORR: 78.0% vs. 73.1%

mDoR: 5.3 mos vs. 4.3 mos (HR: 0.63 [0.49-0.81])

mPFS: 5.8 mos vs. 5.6 mos (HR: 0.67 [0.54-0.82])

6-mo PFS: 47.1% vs. 36.3%

12-mo PFS: 18.1% vs. 4.9%

mOS: 14.6 mos vs. 13.3 mos (HR: 0.80 [0.65-0.98])

12-mo OS: 63.1% vs. 54.9%

24-mo OS: 25.9% vs. 19.5%

Grade ≥3 AEs: Neutropenia (74.3% vs. 75.0%), anemia (30.6% vs. 34.7%), thrombocytopenia (24.8% vs. 34.3%)

Immune-related AEs: Hypothyroidism (6.8% vs. 2.3%), pneumonitis (4.5% vs. 1.4%), hyperthyroidism (4.1% vs. 1.9%)

Serious AEs: 50.0% vs. 37.5%

Treatment-related discontinuations: 12.6% vs. 7.9%

Treatment-related deaths: 5.4% vs. 3.2%

Cheng Y,Zhang W,Wu L Toripalimab Plus Chemotherapy as a First-Line Therapy for Extensive-Stage Small Cell Lung Cancer: The Phase 3 EXTENTORCH Randomized Clinical Trial

Reviewed by Ulas D. Bayraktar, MD on Apr 7, 2025