Phase III Trial Comparing Cryoablation Plus Pembrolizumab and Pemetrexed-Carboplatin Versus Pembrolizumab and Pemetrexed-Carboplatin Alone in First-Line Treatment of Metastatic Lung Adenocarcinoma

What this Trial Is About

Researchers are evaluating whether adding cryoablation to standard treatment with pembrolizumab, pemetrexed, and carboplatin improves one-year survival in patients with metastatic lung adenocarcinoma. This phase III, multicenter, open-label trial compares two groups one receiving cryoablation plus standard drugs and the other receiving only the standard drug combination. The study investigates the possible survival benefit of combining these treatments for this advanced lung cancer. Participants are randomly assigned to one of two arms. The experimental arm receives cryoablation of one eligible visceral or bone metastasis excluding liver and sclerotic bone lesions alongside pembrolizumab and pemetrexed-carboplatin given according to approved dosing. Cryoablation is performed within 6 weeks after starting pembrolizumab. The control arm receives pembrolizumab, pemetrexed, and carboplatin without cryoablation. Treatment continues until disease progression, unacceptable toxicity, or other reasons for stopping. Participants undergo tumor assessments at baseline and every 9 weeks using RECIST v1.1 criteria. Blood samples and optional biopsies are collected at specified times including before treatment and at progression. Safety is monitored up to 90 days after the last immunotherapy or 12 months of treatment. Follow-up continues for up to 36 months after randomization to track tumor response, survival, and quality of life. The primary outcome is one-year overall survival rate, with multiple secondary outcomes including response rates and adverse events.

Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in 1st-line Treatment for Patients With Metastatic Lung Adenocarcinoma