Pazopanib (P) Or Placebo In Completely Resected Stage I Nsclc Patients: Survival Results Of The Phase Ii Trial Ifct-0703.

7510 Background: P is an anti-angiogenic agent approved in metastatic renal cell carcinoma and sarcoma. We have previously reported compliance of adjuvant P (i.e. % of patients (pts) able to receive at least 3 months (m.) of P, whatever the dose) in stage I NSCLC. Compliance has already been reported (WCLC 2013) and has been found adequate at the dose 400 mg/d (69% [95%CI 50-84] (p = 0.027, compared to 38% in P 800 mg/d) vs 93% [95%CI 77-99] in placebo. Here we report survival data. Methods: In this double-blind non-comparative randomized multicenter phase II trial, 143 pts with resected stage I NSCLC (7thTNM edition) were randomized to receive placebo or P 800 mg/d during 6 m. The Fleming’s two-stage primary endpoint was compliance. After 64 pts included (interim analysis), IDMC recommended to start with P 400 mg/d because of initial insufficient compliance. A one-step Fleming design was used with the new dose. Here, we present survival data for which the intent to treat analysis was performed in 142 pts...