NCT02143466

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Official title

A Multi-arm, Phase Ib, Open-Label, Multicentre Study to Assess the Safety,Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9291 in Combination With Ascending Doses of Novel Therapeutics in Patients With EGFRm+ Advanced NSCLC Who Have Progressed Following Therapy With an EGFR TKI (TATTON).

Phase

Phase 1

Status

Active not recruiting

Conditions

Advanced Non Small Cell Lung Cancer

Interventions

Part A - AZD9291 in combination with AZD6094; Part A - AZD9291 in combination with continuous selumetinib (Asian subjects); Part A - AZD9291 in combination with continuous selumetinib (non-Asian subjects); Part A - AZD9291 in combination with intermittent selumetinib; Part A - AZD9291 in combination with MEDI4736; Part B - AZD9291 in combination with AZD6094; Part B - AZD9291 in combination with selumetinib; Part B - AZD9291 in combination with MEDI4736; Part C - AZD6094 monotherapy (Japan only); Part C - AZD9291 in combination with AZD6094 (Japan only); Part D - AZD9291 in combination with AZD6094

Arms

• AZD6094 · Experimental
• Selumetinib · Experimental
• MEDI4736 · Experimental
• AZD6094 (monotherapy) · Experimental

Enrollment

344

Primary outcomes

• Number of participants with Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and Tolerability of AZD9291 when given in combination with AZD6094 or selumetinib
• Number of participants with Adverse Events as a measure of Safety and Tolerability of AZD9291 when given in combination with AZD6094 or selumetinib

Sponsor

AstraZeneca

Start

Aug 5, 2014

Primary completion

Mar 4, 2020

Results posted

No

Registry record

NCT02143466 · updated Jul 20, 2026

• Ahn MJ, Cho BC, Ou X, Walding A, Dymond AW, Ren S, Cantarini M, Janne PA. Osimertinib Plus Durvalumab in Patients With EGFR-Mutated, Advanced NSCLC: A Phase 1b, Open-Label, Multicenter Trial. J Thorac Oncol. 2022 May;17(5):718-723. doi: 10.1016/j.jtho.2022.01.012. Epub 2022 Feb 15. PubMed 35181499
• Yoh K, Hirashima T, Saka H, Kurata T, Ohe Y, Hida T, Mellemgaard A, Verheijen RB, Ou X, Ahmed GF, Hayama M, Sugibayashi K, Oxnard GR. Savolitinib +/- Osimertinib in Japanese Patients with Advanced Solid Malignancies or EGFRm NSCLC: Ph1b TATTON Part C. Target Oncol. 2021 May;16(3):339-355. doi: 10.1007/s11523-021-00806-5. Epub 2021 May 3. PubMed 33939068
• Oxnard GR, Yang JC, Yu H, Kim SW, Saka H, Horn L, Goto K, Ohe Y, Mann H, Thress KS, Frigault MM, Vishwanathan K, Ghiorghiu D, Ramalingam SS, Ahn MJ. TATTON: a multi-arm, phase Ib trial of osimertinib combined with selumetinib, savolitinib, or durvalumab in EGFR-mutant lung cancer. Ann Oncol. 2020 Apr;31(4):507-516. doi: 10.1016/j.annonc.2020.01.013. Epub 2020 Jan 24. PubMed 32139298
• Sequist LV, Han JY, Ahn MJ, Cho BC, Yu H, Kim SW, Yang JC, Lee JS, Su WC, Kowalski D, Orlov S, Cantarini M, Verheijen RB, Mellemgaard A, Ottesen L, Frewer P, Ou X, Oxnard G. Osimertinib plus savolitinib in patients with EGFR mutation-positive, MET-amplified, non-small-cell lung cancer after progression on EGFR tyrosine kinase inhibitors: interim results from a multicentre, open-label, phase 1b study. Lancet Oncol. 2020 Mar;21(3):373-386. doi: 10.1016/S1470-2045(19)30785-5. Epub 2020 Feb 3. PubMed 32027846