TRITON: First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients with Non-Squamous Histology
Condition: Non-Small Cell Lung Cancer
Sponsor: AstraZeneca LP
Full Title
A Phase IIIb, Randomized, Multicenter, Open-label Study to
assess the Efficacy of Durvalumab plus Tremelimumab versus
Pembrolizumab in Combination with Platinum-Based
Chemotherapy for First-Line Treatment in Metastatic Non-Small
Cell Lung Cancer Patients with Non-Squamous Histology who
have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS
(TRITON)
Study Treatment
Durvalumab plus Tremelimumab versus Pembrolizumab in Combination with
Platinum-Based Chemotherapy for First-Line Treatment
Eligibility/Info
Histologically or cytologically documented Stage IV non-squamous NSCLC not amenable to curative surgery or radiation.
STK11 or KEAP1 or KRAS mutations.
Co-mutations are also allowed (STK11 and KRAS mutations, STK11 and KEAP1 mutations, or KEAP1 and KRAS mutations).
Participants must have tumors that lack activating EGFR mutations (eg, exon 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, exon 20 insertions, or exon 20 S768I mutation) and ALK fusions.
No prior chemotherapy or any other systemic therapy for metastatic NSCLC. Participants who have received prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred >6 months from end of last therapy
No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anti-cancer vaccines, within 12 months to randomization.
Contact
For more information you may contact the Research Department through the NYCBS HALO Messaging Center or call directly: 631-675-5075.